COOL AMI EU Pilot Trial to Assess Cooling as an Adjunctive Therapy to Percutaneous Intervention in Patients With Acute Myocardial Infarction
NCT ID: NCT02509832
Last Updated: 2020-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2015-07-31
2018-06-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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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.
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.
PCI only
Standard of Care for PCI
Interventions
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Cooling + PCI
Cooling with ZOLL Proteus IVTM System before and after Percutaneous Coronary Intervention (PCI)
PCI only
Standard of Care for PCI
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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ZOLL Circulation, Inc., USA
INDUSTRY
Responsible Party
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Principal Investigators
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Michael Holzer
Role: PRINCIPAL_INVESTIGATOR
Universitätsklinik für Notfallmedizin Allgemeines Krankenhaus der Stadt Wien
Marko Noc
Role: PRINCIPAL_INVESTIGATOR
University Medical Center Ljubljana Slovenia
Locations
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Universitätsklinik für Notfallmedizin Allgemeines Krankenhaus der Stadt Wien
Vienna, , Austria
North Estonia Medical Center
Tallinn, , Estonia
Heart Center Balatonfüred
Balatonfüred, , Hungary
Medical and Health Science Center University of Debrecen
Debrecen, , Hungary
Heart Institute University of Pecs
Pécs, , Hungary
Medical University in Łódź, Bieganski Hospital
Lodz, , Poland
National Institute of Cardiology, Department of Interventional Cardiology & Angiology
Warsaw, , Poland
Silesian Center for Heart Diseases
Zabrze, , Poland
Clinical Center of Serbia Head of Department for invasive diagnostics (Division of Cardiology)
Belgrade, , Serbia
University Clinical Hospital Center Zemun
Zemun, , Serbia
University Medical Centre Ljubljana
Ljubljana, , Slovenia
Skane University Hospital Lund University
Lund, , Sweden
Essex Cardiothoracic Centre, Anglia Ruskin University
Basildon, Essex, United Kingdom
Countries
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Other Identifiers
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EDC-2420
Identifier Type: -
Identifier Source: org_study_id