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IK-5001 for the Prevention of Remodeling of the Ventricle and Congestive Heart Failure After Acute Myocardial Infarction (PRESERVATION 1)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Bellerophon
Sponsor:
Information provided by (Responsible Party):
Bellerophon ( Bellerophon BCM LLC )
ClinicalTrials.gov Identifier:
NCT01226563
First received: October 20, 2010
Last updated: October 2, 2014
Last verified: October 2014
  Purpose

The primary objective is to evaluate the safety and effectiveness of the IK-5001 device for the prevention of ventricular remodeling and congestive heart failure when administered to subjects who had successful percutaneous coronary intervention with stent placement after ST segment elevation MI (STEMI).


Condition Intervention
Acute Myocardial Infarction
Congestive Heart Failure
ST-Elevation Myocardial Infarction
Device: Sodium Alginate and Calcium Gluconate
Device: Saline Solution

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: A Placebo Controlled , Multicenter, Randomized, Double Blind Trial to Evaluate the Safety and Effectiveness of IK-5001 for the Prevention of Remodeling of the Ventricle and Congestive Heart Failure After Acute Myocardial Infarction - Preservation I Trial

Resource links provided by NLM:


Further study details as provided by Bellerophon:

Primary Outcome Measures:
  • Left Ventricular End Diastolic Volume Index [ Time Frame: Baseline, 6 Months ] [ Designated as safety issue: No ]
    Anatomic measurement of left ventricular end diastolic volume index (LVEDVI) assessed through echocardiogram.


Secondary Outcome Measures:
  • Kansas City Cardiomyopathy Questionaire [ Time Frame: Baseline (prior to index STEMI), 1, 3, 6 and 12 month follow-up visits ] [ Designated as safety issue: No ]
    Patient reported outcomes (PROs) using The Kansas City Cardiomyopathy Questionaire (KCCQ) score - a validated disease-specific self-administered 23-item questionnaire that will be used to quantify symptoms, function, and quality of life of subjects.

  • Six minute walk test [ Time Frame: Baseline (prior to index STEMI), 1, 3, 6 and 12 month follow-up visits ] [ Designated as safety issue: No ]
    The six minute walk test (6MWT) is used for measuring the response to medical interventions in subjects with moderate to severe heart disease, functional status of subjects, as well as a predictor of morbidity and mortality

  • New York Heart Association (NYHA) functional classification (Physician reported) [ Time Frame: Baseline (prior to index STEMI), 1, 3, 6 and 12 month follow-up visits ] [ Designated as safety issue: Yes ]
    New York Heart Association (NYHA) classification assessed by physician will be categorized by Class (Class I - IV)

  • Cardiovascular death, non-fatal heart failure events or cardiovascular hospitalizations [ Time Frame: Study duration ] [ Designated as safety issue: Yes ]
    Time to cardiovascular death, non-fatal heart failure events or cardiovascular hospitalizations adjudicated by a Clinical Events Committee

  • Re-hospitalization due to any cardiovascular event [ Time Frame: Study duration ] [ Designated as safety issue: Yes ]
    Time to re-hospitalization due to any cardiovascular event


Other Outcome Measures:
  • NT-pro-brain natriuretic peptide (NT-proBNP) levels [ Time Frame: Baseline, discharge, 1, 3, and 6 month follow-up visits. ] [ Designated as safety issue: No ]
    NT-pro-brain natriuretic peptide (NT-proBNP) levels

  • Short Form 12 (SF-12) Questionnaire [ Time Frame: Baseline (prior to the index STEMI), 1, 3, 6 and 12 month follow-up visits ] [ Designated as safety issue: No ]
    The SF-12 is a validated general quality of life self-administered instrument that has been used in various disease states.

  • Measurement of alginate in plasma and urine [ Time Frame: Baseline, 5, 30 min, 1, 3, 8, 24, 48 hrs, 1, 3 month ] [ Designated as safety issue: No ]

    At selected sites, relatively intensive sampling: blood will be drawn just prior to deployment (0 hour), 5 and 30 minutes and 1, 3, 8, 24, 48 hrs post deployment or until discharge, whichever occurs first, and at 1 and 3 month follow-up visit.

    At selected sites, urine collection for measurements of alginate, 4 urine samples, will be collected at baseline (within 30 min prior to deployment), 0-8 hrs (from the time immediately following the device deployment through 8 hrs post deployment), 8 through 24 hours through post deployment, 24 through 48 hrs or discharge (whichever comes first). In addition, a urine sample will be taken at 1 and 3 month follow-up visits.


  • Healthcare utilization [ Time Frame: 6 and 12 month follow-up visits. ] [ Designated as safety issue: No ]
    The healthcare utilization and questionnaire consists of subject responses to questions regarding mobility, self-care, usual activities, pain, discomfort, anxiety and depression.

  • Anatomic endpoints [ Time Frame: 4 to 6 hours following deployment, 1, 3 and 12 month follow-up visits ] [ Designated as safety issue: No ]
    Anatomic endpoints: ejection fraction, end systolic volume index, mitral regurgitation, diastolic function, sphericity index, wall thickness, wall motion score and left ventricular (LV) mass index derived from the echocardiogram.

  • Primary Safety Evaluation [ Time Frame: Study duration ] [ Designated as safety issue: Yes ]

    The following safety endpoints will be adjudicated by a Clinical Events Classification Committee:

    1. Death
    2. Recurrent myocardial infarction (MI) or target vessel revascularization or stent thrombosis
    3. Significant arrhythmia requiring therapy
    4. Myocardial rupture

  • Long-term Safety Evaluation [ Time Frame: Up to 5 years after device deployment ] [ Designated as safety issue: Yes ]
    1. Death

      • If death: adjudicate for "cardiovascular" or "non-cardiovascular" or "cannot be determined"

    2. Need for devices for the management of congestive heart failure (CHF)

      • automated implantable cardiac defibrillator (AICD)
      • cardiac resynchronization therapy
      • left ventricular assist device (LVAD)
    3. Heart transplant

  • Continuous Electrocardiogram Cardiac Safety Endpoints [ Time Frame: Baseline, prior to discharge, 1, 3 and 6 month follow-up visits ] [ Designated as safety issue: Yes ]
    • New ischemia by ST segment deviation
    • QT/QTcF (Fridericia's heart rate correction) before and 18 hours after procedure
    • Severe bradycardia or tachycardia, including sustained ventricular or supraventricular tachycardia, total beats in episodes of tachycardia, total pauses and newly paced beats.

  • Clinical Chemistry, Hematology, and Urinalysis panel [ Time Frame: Clinical Chemistry, Hematology: Baseline, 8 hours (± 2 hours) post-deployment, 1, 3, and 6 month follow-up visits. Urinalysis : Baseline and discharge ] [ Designated as safety issue: Yes ]

    Chemistry panel - levels of albumin, alkaline phosphatase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), blood urea nitrogen, calcium, serum chloride, bicarbonate, direct bilirubin, creatinine, γ-GT, glucose, lactate dehydrogenase, potassium, sodium, and total bilirubin.

    Hematology panel - hemoglobin, hematocrit, mean corpuscular volume (MCV), red blood cell count (RBC), white blood cell (WBC) levels (with 5 part differential), and platelet count.

    Urinalysis - pH, specific gravity, RBC, WBC, glucose, protein in the urine, and a Human chorionic gonadotropin (HCG) pregnancy test


  • Performance Goal and Study Success [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
    5 mL change or greater in LVEDVI in IK-5001 group vs. placebo


Estimated Enrollment: 306
Study Start Date: April 2012
Estimated Study Completion Date: August 2020
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IK-5001
IK-5001 is a aqueous mixture of sodium alginate and calcium gluconate. A 4 mL (+/- 0.2 mL)slow bolus, intracoronary injection of IK-5001 will be administered over 30 to 60 seconds
Device: Sodium Alginate and Calcium Gluconate
4 mL (+/- 0.2 mL)administered through intracoronary slow bolus injection over 15 to 30 seconds at least 2 days after PCI but within 5 days of onset of symptoms.
Other Names:
  • IK-5001
  • BIOABSORBABLE CARDIAC MATRIX (BCM)
Placebo Comparator: Saline Solution
A 4 mL (+/- 0.2 mL)slow bolus intracoronary injection of saline solution will be administered over 30 to 60 seconds
Device: Saline Solution
4 mL (+/- 0.2 mL)slow bolus, intracoronary injection of saline solution will be administered over 15 to 30 seconds at least 2 days after percutaneous coronary intervention (PCI) but within 5 days of onset of symptoms.

Detailed Description:

Heart failure is a significant problem, and carries substantial mortality. According to studies, left ventricular (LV) remodeling contributes independently to heart failure progression. Prevention and reversal of LV remodeling are correlated with decreased risk of death and heart failure events. IK-5001 is an implantable device to be used in subjects with recent myocardial infarction (MI). The IK-5001 device has been shown to directly halt the remodeling process that occurs following acute MI. IK-5001 replaces the damaged extracellular matrix (ECM) that has degraded during infarction, supports the damaged myocardial tissue, prevents local dyskinesis, and decreases wall stress. Because of its minimal interaction with the myocardium, its mechanism of action, its lack of specific pharmacologic activity and its elimination behavior, IK-5001 is a medical device in concurrence with the Global Harmonization Task Force's harmonized definition for medical devices.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

Subjects must meet all of the following inclusion criteria to participate in this trial:

  1. The subject is ≥ 18 years of age.
  2. The subject has given informed consent.
  3. The subject has experienced a large STEMI defined by the following criteria:

    Peak cardiac enzyme value within 48 hours of symptom onset as follows:

    • Creatine kinase MB fraction (CK-MB) > 30 x the upper limit of normal OR
    • Troponin I > 200 x upper limit of normal OR
    • Troponin T > 60 x the upper limit of normal

    AND at least 1 of the following 3 criteria:

    • Delayed presentation with PCI > 6 hours from onset of symptoms
    • Significant new Q waves in ≥ 2 anterior leads or anterior ST segment elevation of at least 3 mm persistent at 24 hours after PCI
    • New onset of CHF (Killip class 3-4) or cardiogenic shock persistent at 24 hours after PCI

    AND at least 1 of the following 2 criteria:

    • MI ≥ 20% by Single Photon Emission Computed Tomography scan (SPECT) or cardiac Magnetic Resonance Imaging (MRI) with defect in the appropriate distribution
    • Ejection fraction ≤ 35% with wall motion abnormality in the appropriate distribution at baseline imaging assessment
  4. The subject has had successful PCI with stent within 48 hours of symptom onset, and residual stenosis less than 20% in the infarct related artery and greater than or equal to thrombolysis in myocardial infarction (TIMI) 2 flow. Subjects undergoing rescue PCI after thrombolysis or delayed presentation with ongoing ischemia may be enrolled.
  5. For Germany only: Patients determined to have Killip class 4 at time of device deployment are not eligible for randomization.
  6. For Germany only: If SPECT is used for determination of MI size in order to meet inclusion criteria, the SPECT must have been previously performed as part of standard clinical care. SPECT is not to be performed solely to qualify a patient for this study in Germany.

Exclusion criteria:

Subjects will be excluded from participating in this trial if ANY of the following exclusion criteria are met:

  1. Any subject with cardiogenic shock requiring mechanical ventilation or mechanical support at the time of deployment. Subject must be off mechanical support prior to deployment.
  2. Need for urgent coronary artery bypass graft (CABG)
  3. Clinically significant valvular heart disease with planned surgical correction or transcatheter aortic valve implantation (TAVI)
  4. Uncontrolled ventricular arrhythmias
  5. Renal insufficiency with a calculated creatinine clearance of less than 30 mL/ minute. See Appendix A for determining estimated creatinine clearance.
  6. Clinically significant hepatic insufficiency
  7. Inadequate imaging windows (defined as the inability to visualize the endocardial border of at least 16 of the 17 segments in both the apical four chambers and apical two chamber views without foreshortening) or arrhythmia that would preclude adequate 3D imaging on transthoracic echocardiography at the local baseline echo assessment
  8. Non-ambulatory prior to the index MI
  9. The subject has participated in another trial of an investigational agent within 30 days prior to randomization.
  10. Subject has received resorbable stent as part of PCI.
  11. The subject is pregnant or breastfeeding. Women of child-bearing potential will have a negative urine pregnancy test prior to randomization.
  12. Any other concurrent condition that, in the opinion of the investigator, would prevent completion of the clinical trial, including inability to comply with follow up requirements.
  13. For Germany only: In the investigator's opinion, the patient is not expected to survive ≥12 months.
  14. For Germany only: 24 hours prior to device deployment, the patient has a serum calcium level greater than the upper limit of normal as determined by the local laboratory.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01226563

Contacts
Contact: Diane Stebbins 908-574-4847 diane.stebbins@bellerophon.com

  Hide Study Locations
Locations
United States, Alabama
Cardiology, P.C. Recruiting
Birmingham, Alabama, United States, 35211
Principal Investigator: Thomas Cawthon Jr., MD         
United States, California
Harbor - UCLA Medical Center Recruiting
Torrance, California, United States, 90509
Principal Investigator: William J. French, MD         
United States, District of Columbia
MedStar Washington Hospital Center Recruiting
Washington, District of Columbia, United States, 20010
Principal Investigator: Ron Waksman, MD         
United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32610
Principal Investigator: Carl J Pepine, MD         
University of Miami Hospital Recruiting
Miami, Florida, United States, 33136
Principal Investigator: Mauricio Cohen, M.D.         
United States, Indiana
St. Vincent Medical Group Inc. Recruiting
Indianapolis, Indiana, United States, 46290
Principal Investigator: James B. Hermiller, MD         
United States, Michigan
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48202
Principal Investigator: Adam Greenbaum, MD         
United States, Minnesota
Minneapolis Heart Institute Recruiting
Minneapolis, Minnesota, United States, 55407
Principal Investigator: Jay H. Traverse, MD         
United States, New York
Montefiore Medical Center Weiler Division Recruiting
Bronx, New York, United States, 10461
Principal Investigator: Vankeepuram S. Srinivas, MD         
Buffalo Heart Group LLP Withdrawn
Buffalo, New York, United States, 14215
Stony Brook Medicine Recruiting
Stony Brook, New York, United States, 11794
Principal Investigator: Luis Gruberg, MD         
United States, North Carolina
East Carolina Heart Institute - ECHI Recruiting
Greenville, North Carolina, United States, 27834
Principal Investigator: Ramesh Daggubati, MD         
United States, Ohio
Carl and Edyth Lindner Center for Research and Education @ Christ Hospital Recruiting
Cincinnati, Ohio, United States, 45219
Principal Investigator: Ian J. Sarembock, MD         
Ohio Health Research Institute Recruiting
Columbus, Ohio, United States, 43214
Principal Investigator: Steven Yakubov, MD         
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
Principal Investigator: Ian Gilchrist, MD         
Allegheny General Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Principal Investigator: David Lasorda, DO         
United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
Principal Investigator: J. Dawn Abbott, MD         
Australia, Queensland
Gold Coast Hospital Recruiting
Southport, Queensland, Australia, 4215
Principal Investigator: Rohan Jayasinghe, MD         
Princess Alexandra Hospital Recruiting
Woolloongabba, Brisbane, Queensland, Australia, 4102
Principal Investigator: Paul Garrahy, MD         
Australia, South Australia
The Queen Elisabeth Hospital Recruiting
Woodville South, South Australia, Australia, 5011
Principal Investigator: John Horowitz, MD         
Australia
Flinders Medical Centre Recruiting
Bedford Park, Australia, 5042
Principal Investigator: Derek Chew, MD         
Alfred Hospital Recruiting
Melbourne, Victoria, Australia, 3004
Principal Investigator: Henry Krum, MD         
The Northern Hospital Recruiting
Melbourne, Victoria, Australia, 3076
Principal Investigator: William vanGaal, MD         
Royal Perth Hospital - Dept. of Cardiology Recruiting
Perth, Australia, 6000
Principal Investigator: Matthew Erickson, M.D.         
Belgium
ZNA Middelheim Recruiting
Antwerpen, Belgium, 2020
Principal Investigator: Paul Vermeersch, MD         
Universitair Ziekenhuis Brussel Recruiting
Brussel, Belgium, 1090
Principal Investigator: Danny Schoors, MD         
Ziekenhuis Oost-Limburg (ZOL) Recruiting
Genk, Belgium, 3600
Principal Investigator: Joseph Dens, MD         
CHU du Sart Tilman Recruiting
Liege, Belgium
Principal Investigator: Victor Legrand, MD         
Canada, Alberta
Royal Alexandra Hospital Recruiting
Edmonton, Alberta, Canada, T5H 3V9
Principal Investigator: Neil Brass, MD         
Canada, Nova Scotia
Queen Elizabeth II Health Science Centre Recruiting
Halifax, Nova Scotia, Canada, B3H 3A7
Principal Investigator: Ata-ur-Rehman Quraishi, MD         
Canada, Ontario
York PCI Research Recruiting
Newmarket, Ontario, Canada, L3Y 2P7
Principal Investigator: Warren Cantor, M.D.         
Canada
Montreal Heart Institute Recruiting
Montreal, Canada, QC H1T 1C8
Principal Investigator: Jean-Francois Tanguay, MD         
Centre Hospitalier de l'Universite de Montreal (CHUM) Recruiting
Quebec, Canada, 3840
Principal Investigator: Andre Kokis, MD         
Centre Hospitalier Universitaire de Sherbrooke Recruiting
Quebec, Canada, J1H 5N4
Principal Investigator: Michel Nguyen, MD         
Institut universitaire de cardiologie et de pneumologie de Quebec (IUCPQ) Withdrawn
Quebec, Canada, G1V 4G5
St. Michael's Hospital Recruiting
Toronto, Ontario, Canada, M5B-1W8
Principal Investigator: Christopher Buller, MD         
France
Hopital de Brive Service de Cardiologie Recruiting
Brive la Gaillarde, France, 19312
Principal Investigator: Sebastien Bosle, MD         
Hopital Henri Mondor Recruiting
Creteil Cedex, France, 94010
Principal Investigator: Emmanuel Teiger, Prof         
Hopital du Bocage Central Recruiting
Dijon Cedex, France, 21079
Principal Investigator: Yves Cottin, MD         
CHU Grenoble - Hopital Michallon Recruiting
Grenoble Cedex 09, France
Principal Investigator: Gerald Vanzetto, Prof.         
Hopital Charles Nicolle Recruiting
Haute Normandie, France, 7601
Principal Investigator: Christophe Tron, MD         
Centre Hospitalier Regional Universitaire de Lille Recruiting
Lille, France, 59037
Principal Investigator: Eric Van Belle, Prof         
Centre Hospitalier Universitaire de Nice Hopital Pasteur Recruiting
Nice Cedex 1, France, 06002
Principal Investigator: Emile Ferrari, MD         
Hopital Lariboisiere Recruiting
Paris, France, 75010
Principal Investigator: Damien Logeart, MD         
Nouvel Hopital Civil Recruiting
Strasbourg Cedex, France, 67091
Principal Investigator: Patrick Ohlmann, MD         
CHU de Toulouse - Hopital Rangueil Recruiting
Toulouse, France, 31059
Principal Investigator: Jerome Roncalli, MD         
Germany
Vivantes Humboldt-Klinikum Recruiting
Berlin, Germany, 13509
Principal Investigator: Steffen Behrens, MD         
Vivantes Netzwerk fur Gesundheit GmbH, Kinikum Neukolln Recruiting
Berlin, Germany, 12351
Principal Investigator: Harald Darius, MD         
Helios Klinikum Erfurt Recruiting
Erfurt, Germany, 99089
Principal Investigator: Harald Lapp, MD         
Elisabeth-Krankenhaus Recruiting
Essen, Germany, 45138
Principal Investigator: Christoph K. Naber, MD         
Universitatsklinikum Heidelberg Recruiting
Heidelberg, Germany, 69120
Principal Investigator: Emmanuel Chorianopoulos, MD         
Universitatsklinikum Jena, Klinik fur Innere Medizin, Kardiologie Recruiting
Jena, Germany, 07747
Principal Investigator: Hans R. Figulla, MD         
Klinik fur Kardiologie and Angiologie Universitatsklinikum Recruiting
Kiel, Germany, 24105
Principal Investigator: Norbert Frey, MD         
Universitatsklinikum Koln Withdrawn
Koln, Germany, 50937
University of Leipzig Recruiting
Leipzig, Germany, D-04289
Principal Investigator: Axel Linke, MD         
Universitatsklinikum Schleswig-Holstein Recruiting
Lubeck, Germany, 23538
Principal Investigator: Kai Mortensen, M.D.         
Klinikum der Stadt Ludwigshafen am Rhein gGmbH Recruiting
Ludwigshafen, Germany, D-67063
Principal Investigator: Uwe Zeymer, MD         
Universitatsmedizin Mannheim Recruiting
Mannheim, Germany, D-68167
Principal Investigator: Ralf Lehmann, M.D.         
Klinikum der Universitat Munchen LMU Recruiting
Munchen, Germany, 81377
Principal Investigator: Christian Kupatt, Prof. Dr. med         
Stadtische Kliniken Neuss - Lukaskrankenhaus Recruiting
Neuss, Germany, 41464
Principal Investigator: Michael Haude, MD         
Klinikum Oldenburg gGmbH Recruiting
Oldenburg, Germany, 26133
Principal Investigator: Albrecht Elsasser, MD         
St. Marien-Krankenhaus Siegen gem. GMbH Recruiting
Siegen, Germany, 57072
Principal Investigator: Michael Buerke, MD         
Krankenhaus Barmherzige Brüder Abt.Kardiologie und Pneumologie Recruiting
Trier, Germany, 54292
Principal Investigator: Karl E Hauptmann, MD         
Helios Klinikum Wuppertal Recruiting
Wuppertal, Germany, 42117
Principal Investigator: Klaus Tiroch, MD         
Israel
The Edith Wolfson Medical Center Recruiting
Holon, Tel Aviv, Israel, 58100
Principal Investigator: Yoseph Rozenman, MD         
HaEmek Medical Center Recruiting
Afula, Israel, 18101
Principal Investigator: Yoav Turgeman, MD         
Barzilai Medical Center Recruiting
Ashkelon, Israel, 78278
Principal Investigator: Amos Katz, MD         
The Lady Davis Carmel Medical Center Recruiting
Haifa, Israel, 34362
Principal Investigator: Amnon Merdler, MD         
Rambam Medical Center Recruiting
Haifa, Israel, 31096
Principal Investigator: Eitan Abergel, MD         
B'nai Zion Medical Center Active, not recruiting
Haifa, Israel
Hadassah University Medical Center Jerusalem-Cardiology Recruiting
Jerusalem, Israel, 91120
Principal Investigator: Arthur Pollak, MD         
Kaplan Medical Center Recruiting
Rehovot, Israel
Principal Investigator: Oscar Kracoff, MD         
Sheba Medical Center - Tel Hashomer Recruiting
Tel Hashomer, Israel, 52621
Principal Investigator: Victor Guetta, MD         
Poland
UCK, Kliniczne Centrum Kardiologii Recruiting
Gdnask, Poland, 80-952
Principal Investigator: Grzegorz Raczak, Prof.         
Centrum Interwencyjnego Leczenia Chorob Serca i Naczyn z Pododdzialem Kardiologii Interwencyjnej Recruiting
Krakow, Poland, 31-202
Principal Investigator: Jaroslaw Trebacz, MD         
I Klinika Kardiologii i Elektrokardiologii lnterwencyjnej oraz Nadcisnienia Tetniczego CM UJ Recruiting
Kraków, Poland, 31-501
Principal Investigator: Danuta Czarnecka, MD         
Oddzial Kardiologiczny Wojewodzki Specjalistyczny Szpital im. Bieganskiego w Lodzi Recruiting
Lodz, Poland, 91-347
Principal Investigator: Jaroslaw Kasprzak, MD         
Samodzileny Publiczny Szpital Kliniczny nr 4 w Lublinie Recruiting
Lublin, Poland, 20-954
Principal Investigator: Andrzej Wysokinski, MD         
Samodzielny Publiczny Szpital Kliniczny nr 2 PUM w Szczecinie Recruiting
Szczecin, Poland, 70-111
Principal Investigator: Zdzislawa Kornacewicz-Jach, MD         
Pracownia Kardiologii Inwazyjnej Recruiting
Warsaw, Poland, 02-097
Principal Investigator: Janusz Kochman, MD         
Cetrainy Szpital Kliniczny MSWIA Recruiting
Warszawa, Poland, 02-507
Principal Investigator: Robert Gil, Prof. Dr         
Spain
Hospital Universitari de Bellvitge Withdrawn
Barcelona, Spain
Hospital del Mar/Passeig Maritim 25-29 Recruiting
Barcelona, Spain, 08003
Principal Investigator: Jordi Bruguera Cortada, MD         
Hospital Juan Ramon Jimenez Recruiting
Huelva, Spain, 21005
Principal Investigator: Jose F. Diaz Fernandez, MD         
Hospital Universitario La Paz Recruiting
Madrid, Spain, 28046
Principal Investigator: Esteban Lopez De Sa Areses, M.D.         
Hospital Universitario Ramon y Cajal Recruiting
Madrid, Spain, 28034
Principal Investigator: Jose L. Zamorano, MD         
Hospital Clinico de Santiago de Compostela Recruiting
Santiago, Spain, 15706
Principal Investigator: Jose R. Gonzalez Juanetey, MD         
Sponsors and Collaborators
Bellerophon BCM LLC
Investigators
Study Director: Reinilde Heyrman, M.D. Bellerophon BCM LLC
  More Information

No publications provided

Responsible Party: Bellerophon ( Bellerophon BCM LLC )
ClinicalTrials.gov Identifier: NCT01226563     History of Changes
Other Study ID Numbers: IK-5001-VENREM-201
Study First Received: October 20, 2010
Last Updated: October 2, 2014
Health Authority: Israel: Ministry of Health
United States: Food and Drug Administration
Belgium: Federal Agency for Medicinal Products and Health Products
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Germany: Federal Institute for Drugs and Medical Devices
Canada: Health Canada
Australia: Department of Health and Ageing Therapeutic Goods Administration
Poland: Ethics Committee

Keywords provided by Bellerophon:
STEMI
Acute Myocardial Infarction
Congestive Heart Failure
Left Ventricular Remodeling

Additional relevant MeSH terms:
Heart Failure
Infarction
Myocardial Infarction
Cardiovascular Diseases
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Vascular Diseases
Alginic acid
Pharmaceutical Solutions
Coagulants
Hematologic Agents
Hemostatics
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Radiation-Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014