Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

COOL-AMI EU Pivotal Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03173313
Recruitment Status : Recruiting
First Posted : June 1, 2017
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
ZOLL Circulation, Inc., USA

Brief Summary:
The objective of this trial is to evaluate the safety and effectiveness of therapeutic hypothermia, using the ZOLL Proteus IVTM System, as an adjunctive therapy for patients presenting with acute anterior myocardial infarction (AMI) and undergoing percutaneous coronary intervention (PCI).

Condition or disease Intervention/treatment Phase
Acute Myocardial Infarction Device: Intravascular permissive hypothermia as an adjunct to PCI Not Applicable

Detailed Description:
A multicenter, prospective, interventional, randomized-controlled trial. Randomization will be in a 1:1 ratio, Test Arm (PCI + Cooling) or Control Arm (PCI alone) in up to 468 randomized subjects (234 subjects in each arm). Endpoint: Relative reduction of 20% in mean anterior myocardial infarct size as determined by Cardiac Magnetic Resonance (cMR) imaging at 4-6 days post infarct in the Test Arm (cooling + PCI) relative to the Control Arm (PCI only).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 468 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: COOL-AMI EU Pivotal Trial: A Multicenter, Prospective, Randomized-Controlled Trial to Assess the Safety and Effectiveness of Cooling As an Adjunctive Therapy to Percutaneous Intervention in Patients With Acute Myocardial Infarction
Actual Study Start Date : April 14, 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


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: Intravascular permissive hypothermia as an adjunct to PCI
Cooling with ZOLL Proteus IVTM System before and after Percutaneous Coronary Intervention (PCI) -or- Standard of Care for 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: Intravascular permissive hypothermia as an adjunct to PCI
Cooling with ZOLL Proteus IVTM System before and after Percutaneous Coronary Intervention (PCI) -or- Standard of Care for PCI




Primary Outcome Measures :
  1. Relative reduction of in mean anterior myocardial infarct size as determined by Cardiac Magnetic Resonance (cMR) imaging at 4-6 days post infarct in the Test Arm (cooling + PCI) relative to the Control Arm (PCI only). [ Time Frame: 4-6 Days ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

Inclusion Criteria:

  1. The patient is ≥ 18 years of age.
  2. The patient must have symptoms consistent with AMI (i.e. chest pain, arm pain, etc.) and unresponsive to nitroglycerin, with symptoms beginning greater than 30 minutes but less than 6 hours prior to presentation at hospital.
  3. Qualifying Infarct location:

    1. Roll-In subjects: Evidence of Acute Anterior or Inferior MI with ST-segment elevation of >= 0.2 mV in two or more anterior or inferior contiguous precordial leads.
    2. Randomized subjects: Evidence of Acute Anterior MI only with ST-segment elevation of >= 0.2 mV in two or more anterior contiguous precordial leads.
  4. The patient is eligible for PCI.
  5. The patient is willing to provide written informed consent to participate in this clinical trial.

Exclusion Criteria:

  1. The patient has had a previous Myocardial Infarction.
  2. The patient is experiencing 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. The patient is presenting with resuscitated cardiac arrest, atrial fibrillation, or Killip risk stratification class II through IV.
  4. The patient has an aortic dissection or requires an immediate surgical or procedural intervention other than PCI.
  5. The patient has known history of Congestive Heart Failure (CHF), hepatic failure, end-stage kidney disease or severe renal failure (clearance < 30ml/min/1.73m²).
  6. The patient is febrile (temperature > 37.5 °C) or has experienced an infection with fever in the last 5 days.
  7. The patient has a known previous CABG.
  8. The patient has a known recent stroke within 90 days of admission.
  9. Cardio-pulmonary decompensation that has occurred en route to the hospital or, in the opinion of the physician, that is imminent or likely to occur following presentation to the clinical site.
  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).The patient has a known hypersensitivity or contraindication to aspirin, heparin, or sensitivity to contrast media, which cannot be adequately pre-medicated.
  11. Any contraindication to cardiac MRI, or any implant in the upper body which may cause artifacts on cardiac MRI imaging.
  12. The patient has a known hypersensitivity or contraindication to aspirin, heparin, or sensitivity to contrast media, which cannot be adequately pre-medicated.
  13. The patient has a known history of bleeding diathesis, coagulopathy, cryoglobulinemia, sickle cell anemia, or will refuse blood transfusions.
  14. The patient has a height of <1.5 meters (4 feet 11 inches).
  15. The patient has a known hypersensitivity or contraindication to buspirone hydrochloride or Pethidine (Meperidine) and/or has been treated with a monoamine oxidase inhibitor in the past 14 days.
  16. Patient has a known 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.
  17. The patient has an Inferior Vena Cava filter in place (IVC).
  18. The patient has a pre-MI life expectancy of <1 year due to underlying medical conditions or pre-existing co-morbidities.
  19. The patient has a known, unresolved history of drug use or alcohol dependency, or lacks the ability to comprehend or follow instructions.
  20. The patient is currently enrolled in another investigational drug or device trial.
  21. The patient is apprehensive about or unwilling to undergo the required MRI imaging at follow-up, has a documented or suspected diagnosis of claustrophobia, or has Gadolinium allergy, or is in permanent Atrial Fibrillation.
  22. The patient has received thrombolytic therapy en route to the hospital.
  23. The patient shows clinical evidence of spontaneous reperfusion as observed symptomatically and/ or from ECG findings (partial or complete ST resolution in ECG prior to informed consent and randomization).
  24. The patient is a vulnerable subject, for instance, a person in detention (i.e., prisoner or ward of the state).
  25. The patient is a 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): NCT03173313


Contacts
Layout table for location contacts
Contact: Philippa Hill (408)-419-2957 phill@zoll.com

Locations
Layout table for location information
Slovenia
University Medical Centre Ljubljana Recruiting
Ljubljana, Slovenia, 1000
Contact: Marko Noc    38 64 172 3807    marko.noc@mf.uni-lj.si   
Contact: Peter Radsel    +38640433599    peter.radsel@mf.uni-lj.si   
Principal Investigator: Marko Noc         
Sub-Investigator: Misa Fister         
Sponsors and Collaborators
ZOLL Circulation, Inc., USA
Investigators
Layout table for investigator information
Principal Investigator: Marko Noc University Medical Center Ljubljana Slovenia

Layout table for additonal information
Responsible Party: ZOLL Circulation, Inc., USA
ClinicalTrials.gov Identifier: NCT03173313     History of Changes
Other Study ID Numbers: EDC-3135
First Posted: June 1, 2017    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ZOLL Circulation, Inc., USA:
Hypothermia
Acute Myocardial Infarction
AMI
PCI
Therapeutic Hypothermia
Additional relevant MeSH terms:
Layout table for MeSH terms
Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases