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

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Myocardial Infarction
• Intervention / Treatment: Device: Cooling + PCI; Device: PCI only

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: 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)
OTHER: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of all subjects who complete the follow-up and cMR imaging requirements at 30-day follow up period	30 day

Secondary Outcome Measures

Outcome Measure	Time Frame
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	4 - 6 days

Collaborators and Investigators

• Sponsor: ZOLL Circulation, Inc., USA
• Investigators: Principal Investigator: Michael Holzer, Universitätsklinik für Notfallmedizin Allgemeines Krankenhaus der Stadt Wien; Principal Investigator: Marko Noc, University Medical Center Ljubljana Slovenia

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (ACTUAL): March 1, 2018
• Study Completion (ACTUAL): June 1, 2018

Study Registration Dates

• First Submitted: July 24, 2015
• First Submitted That Met QC Criteria: July 27, 2015
• First Posted (ESTIMATE): July 28, 2015

Study Record Updates

• Last Update Posted (ACTUAL): November 25, 2020
• Last Update Submitted That Met QC Criteria: November 23, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Percutaneous Coronary Intervention (PCI); Acute Myocardial Infarction (AMI); Therapeutic Hypothermia (TH)
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction
• Other Study ID Numbers: EDC-2420

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED