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COOL AMI EU Pilot Trial to Assess Cooling as an Adjunctive Therapy to Percutaneous Intervention in Patients With Acute Myocardial Infarction

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ClinicalTrials.gov Identifier: NCT02509832
Recruitment Status : Completed
First Posted : July 28, 2015
Last Update Posted : June 27, 2018
Sponsor:
Information provided by (Responsible Party):
ZOLL Circulation, Inc., USA

Brief Summary:

COOL AMI EU Pilot Trial: A Multicenter, Prospective, Randomized Controlled Trial to Assess Cooling as an adjunctive Therapy to Percutaneous Intervention in Patients with Acute Myocardial Infarction.

Evaluate the retention of subjects after integrating therapeutic hypothermia using the ZOLL Proteus IVTM System into existing STEMI treatment protocols for subjects who present with acute anterior myocardial infarction.


Condition or disease Intervention/treatment Phase
Acute Myocardial Infarction Device: Cooling + PCI Device: PCI only Not Applicable

Detailed Description:
Evaluate the retention of subjects after integrating therapeutic hypothermia using the ZOLL Proteus IVTM System into existing STEMI treatment protocols for subjects who present with acute anterior myocardial infarction.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: COOL-AMI EU PILOT TRIAL: A Multicenter, Prospective, Randomized Controlled Trial To Assess Cooling as an Adjunctive Therapy to Percutaneous Intervention in Patients With ACUTE MYOCARDIAL INFARCTION
Study Start Date : July 2015
Actual Primary Completion Date : March 2018
Actual Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Cooling + PCI
The subjects will be considered to be enrolled in the Test Arm of the trial when all inclusion and exclusion criteria have been met, the informed consent form has been signed, and randomization to the Test Arm of the trial to allow cooling with the Proteus IVTM System before and after PCI.
Device: Cooling + PCI
Cooling with ZOLL Proteus IVTM System before and after Percutaneous Coronary Intervention (PCI)

PCI only
The subjects will be considered to be enrolled in the Control Arm of the trial when all inclusion and exclusion criteria have been met, the informed consent form has been signed, and randomization to the Control Arm of the trial to allow PCI only.
Device: PCI only
Standard of Care for PCI




Primary Outcome Measures :
  1. Proportion of all subjects who complete the follow-up and cMR imaging requirements at 30-day follow up period [ Time Frame: 30 day ]

Secondary Outcome Measures :
  1. 1. Anterior Infarct Size (IS) as assessed by Cardiac Magnetic Resonance (cMR) at 4 - 6 days following the index procedure for subjects in Test and Control Arms [ Time Frame: 4 - 6 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

All Inclusion Criteria must be answered YES for subject to be eligible for trial Inclusion Criteria:

  1. ≥ 18 years of age.
  2. symptoms consistent with AMI (chest pain, unresponsive to nitroglycerin, ≥ 30 minutes and < 6 hours.
  3. Anterior MI with ST-segment elevation of 0.2 mV in two or more anterior contiguous precordial leads.
  4. Eligible for PCI.
  5. Opportunity for at least 10 minutes of cooling with the Proteus IVTM System prior to PCI.
  6. Written, informed consent to participate in this clinical trial.

Exclusion Criteria:

All Exclusion Criteria must be answered NO for subject to be eligible for trial inclusion.

  1. Previous myocardial infarction.
  2. Cardiogenic shock (systolic blood pressure [SBP] <80 mmHg and non-responsive to fluids, or SBP <100 mmHg with vasopressors, or requirement for an intra-aortic balloon pump [IABP]).
  3. Resuscitated cardiac arrest, atrial fibrillation, or Killip risk stratification class II through IV
  4. Aortic dissection or requires an immediate surgical or procedural intervention other than PCI
  5. Congestive Heart Failure (CHF), hepatic failure, end- stage kidney disease or severe renal failure (clearance < 30ml/min/1.73m2).
  6. Fever (temperature > 37.5 °C) or infection with fever in the last 5 days.
  7. Previous CABG.
  8. Stroke within 90 days of admission.
  9. Cardio-pulmonary decompensation present or imminent
  10. Contraindications to hypothermia, such as patients with known hematologic dyscrasias which affect thrombosis (e.g., cryoglobulinemia, sickle cell disease, serum cold agglutinins) or vasospastic disorders (such as Raynaud's or thromboangitis obliterans)
  11. Hypersensitivity or contraindication to aspirin, heparin, or sensitivity to contrast media, which cannot be adequately pre-medicated.
  12. History of bleeding diathesis, coagulopathy, cryoglobulinemia, sickle cell anemia, or will refuse blood transfusions.
  13. Height of <1.5 meters (4 feet 11 inches).
  14. Hypersensitivity to buspirone hydrochloride or Pethidine (Meperidine) and/or treatment with a monoamine oxidase inhibitor in the past 14 days.
  15. History of severe hepatic or renal impairment, untreated hypothyroidism, Addison's disease, benign prostatic hypertrophy, or urethral stricture that in the opinion of the physician would be incompatible with Pethidine administration.
  16. Inferior Vena Cava filter in place (IVC).
  17. The patient has a pre-MI life expectancy of <1 year due to underlying medical conditions or pre-existing co-morbidities.
  18. Known, unresolved history of drug use or alcohol dependency, or lacks the ability to comprehend or follow instructions.
  19. Currently enrolled in another investigational drug or device trial that has not completed the primary endpoint.
  20. Apprehension or unwilling to undergo the required MRI imaging at follow-up, has a documented or suspected diagnosis of claustrophobia, or has Gadolinium allergy
  21. Received thrombolytic therapy en route to the hospital
  22. Clinical evidence of spontaneous reperfusion as observed symptomatically and/ or from ECG findings (partial or complete ST resolution in ECG before randomization) upon admission
  23. Vulnerable subject, for instance, a person in detention (i.e., prisoner or ward of the state)
  24. Female who is known to be pregnant.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02509832


Locations
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Austria
Universitätsklinik für Notfallmedizin Allgemeines Krankenhaus der Stadt Wien
Vienna, Austria
Estonia
North Estonia Medical Center
Tallinn, Estonia, 13419
Hungary
Heart Center Balatonfüred
Balatonfüred,, Hungary, 8230
Medical and Health Science Center University of Debrecen
Debrecen, Hungary, 4032
Heart Institute University of Pecs
Pecs, Hungary, H-7624
Poland
National Institute of Cardiology, Department of Interventional Cardiology & Angiology
Warsaw, Poland, 04628
Silesian Center for Heart Diseases
Zabrze, Poland, 41-800
Medical University in Łódź, Bieganski Hospital
Łódź, Poland
Serbia
Clinical Center of Serbia Head of Department for invasive diagnostics (Division of Cardiology)
Belgrade, Serbia
University Clinical Hospital Center Zemun
Zemun, Serbia
Slovenia
University Medical Centre Ljubljana
Ljubljana, Slovenia, 1000
Sweden
Skane University Hospital Lund University
Lund, Sweden
United Kingdom
Essex Cardiothoracic Centre, Anglia Ruskin University
Basildon, Essex, United Kingdom
Sponsors and Collaborators
ZOLL Circulation, Inc., USA
Investigators
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Principal Investigator: Michael Holzer Universitätsklinik für Notfallmedizin Allgemeines Krankenhaus der Stadt Wien
Principal Investigator: Marko Noc University Medical Center Ljubljana Slovenia

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Responsible Party: ZOLL Circulation, Inc., USA
ClinicalTrials.gov Identifier: NCT02509832     History of Changes
Other Study ID Numbers: EDC-2420
First Posted: July 28, 2015    Key Record Dates
Last Update Posted: June 27, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by ZOLL Circulation, Inc., USA:
Therapeutic Hypothermia (TH)
Acute Myocardial Infarction (AMI)
Percutaneous Coronary Intervention (PCI)
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases