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

ZOLL Medical

Status: Completed

Conditions: Acute Myocardial Infarction

Treatments: Device: Cooling + PCI; Device: PCI only

Study type: Interventional

Funder types: Industry

Identifiers

NCT02509832

EDC-2420

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Cooling + PCI

Other group

Description:

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.

Treatment:

Device: Cooling + PCI

PCI only

Other group

Description:

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.

Treatment:

Device: PCI only