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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02509832
• Date of registration: 24/07/2015
• Prospective Registration: No
• Primary sponsor: ZOLL Circulation, Inc., USA
• Public title: COOL AMI EU Pilot Trial to Assess Cooling as an Adjunctive Therapy to Percutaneous Intervention in Patients With Acute Myocardial Infarction
• Scientific 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
• Date of first enrolment: July 2015
• Target sample size: 100
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02509832
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Austria, Estonia, Hungary, Poland, Serbia, Slovenia, Sweden, United Kingdom

Contacts

• Name: Marko Noc
• Affiliation: University Medical Center Ljubljana Slovenia

• Name: Michael Holzer
• Affiliation: Universitätsklinik für Notfallmedizin Allgemeines Krankenhaus der Stadt Wien

Key inclusion & 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Acute Myocardial Infarction

Intervention(s)

Device: Cooling + PCI

Device: PCI only

Primary Outcome(s)

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

Secondary Outcome(s)

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 [Time Frame: 4 - 6 days]

Secondary ID(s)

EDC-2420

Source(s) of Monetary Support

Please refer to primary and secondary sponsors