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

Acute Myocardial Infarction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02509832
• Other study ID #: EDC-2420
• Status: Completed
• Phase: N/A
• Start date: July 2015
• Est. completion date: June 2018

Study information

• Verified date: November 2020
• Source: ZOLL Circulation, Inc., USA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Device:
• Cooling + PCI
Cooling with ZOLL Proteus IVTM System before and after Percutaneous Coronary Intervention (PCI)
• PCI only
Standard of Care for PCI

Locations

Country	Name	City	State
Austria	Universitätsklinik für Notfallmedizin Allgemeines Krankenhaus der Stadt Wien	Vienna
Estonia	North Estonia Medical Center	Tallinn
Hungary	Heart Center Balatonfüred	Balatonfüred,
Hungary	Medical and Health Science Center University of Debrecen	Debrecen
Hungary	Heart Institute University of Pecs	Pecs
Poland	Medical University in Lódz, Bieganski Hospital	Lódz
Poland	National Institute of Cardiology, Department of Interventional Cardiology & Angiology	Warsaw
Poland	Silesian Center for Heart Diseases	Zabrze
Serbia	Clinical Center of Serbia Head of Department for invasive diagnostics (Division of Cardiology)	Belgrade
Serbia	University Clinical Hospital Center Zemun	Zemun
Slovenia	University Medical Centre Ljubljana	Ljubljana
Sweden	Skane University Hospital Lund University	Lund
United Kingdom	Essex Cardiothoracic Centre, Anglia Ruskin University	Basildon	Essex

Sponsors (1)

Lead Sponsor	Collaborator
ZOLL Circulation, Inc., USA

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of all subjects who complete the follow-up and cMR imaging requirements at 30-day follow up period		30 day
Secondary	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