Clinical trial NCT02509832: COOL AMI EU Pilot Trial to Assess Cooling as an Adjunctive Therapy to Percutaneous Intervention in Patients With Acute Myocardial Infarction
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Myocardial Infarction
Keywords: Therapeutic Hypothermia (TH)
Acute Myocardial Infarction (AMI)
Percutaneous Coronary Intervention (PCI)
Lead sponsor: ZOLL Circulation, Inc., USA
Sponsor class: INDUSTRY
First posted: 2015-07-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Eligibility 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.

Primary outcomes:
measure: Proportion of all subjects who complete the follow-up and cMR imaging requirements at 30-day follow up period
timeFrame: 30 day
Secondary outcomes:
measure: 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
timeFrame: 4 - 6 days
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Universitätsklinik für Notfallmedizin Allgemeines Krankenhaus der Stadt Wien
city: Tallinn
country: Estonia
facility: North Estonia Medical Center
city: Balatonfüred,
country: Hungary
facility: Heart Center Balatonfüred
city: Debrecen
country: Hungary
facility: Medical and Health Science Center University of Debrecen
city: Pecs
country: Hungary
facility: Heart Institute University of Pecs
city: Warsaw
country: Poland
facility: National Institute of Cardiology, Department of Interventional Cardiology & Angiology
city: Zabrze
country: Poland
facility: Silesian Center for Heart Diseases
city: Łódź
country: Poland
facility: Medical University in Łódź, Bieganski Hospital
city: Belgrade
country: Serbia
facility: Clinical Center of Serbia Head of Department for invasive diagnostics (Division of Cardiology)
city: Zemun
country: Serbia
facility: University Clinical Hospital Center Zemun
city: Ljubljana
country: Slovenia
facility: University Medical Centre Ljubljana
city: Lund
country: Sweden
facility: Skane University Hospital Lund University
city: Basildon
country: United Kingdom
facility: Essex Cardiothoracic Centre, Anglia Ruskin University
state: Essex
Study officials:
affiliation: Universitätsklinik für Notfallmedizin Allgemeines Krankenhaus der Stadt Wien
name: Michael Holzer
role: PRINCIPAL_INVESTIGATOR
affiliation: University Medical Center Ljubljana Slovenia
name: Marko Noc
role: PRINCIPAL_INVESTIGATOR
References: