COOL AMI EU Pivotal Trial to Assess Cooling as an Adjunctive Therapy to PCI In Patients With Acute MI (Phase A)

NCT03173313 | Completed Results DMC

• 1 other identifier: EDC-3135
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this trial is to evaluate the safety and effectiveness of therapeutic hypothermia, using the ZOLL Proteus IVTM System, as an adjunctive therapy for patients presenting with acute anterior myocardial infarction (AMI) and undergoing percutaneous coronary intervention (PCI).

Conditions

Acute Myocardial Infarction

Keywords

Hypothermia; Acute Myocardial Infarction; AMI; PCI; Therapeutic Hypothermia

Outcome Measures

Primary Outcomes (2)

• Relative Reduction of 20% in Mean Anterior Myocardial Infarct Size as Determined by Cardiac Magnetic Resonance (cMR) Imaging at 4-6 Days Post Infarct in the Test Arm (Cooling + PCI) Relative to the Control Arm (PCI Only).

  The primary outcome is to compare the mean infarct size in the Test Arm (cooling + PCI) to the mean infarct size in the Control Arm (PCI only) at 4-6 days post infarct.

  4-6 Days

• Per-patient Rate of Composite Major Adverse Cardiac Events (MACE) in Randomized Subjects

  The primary safety outcome is to compare the per-patient rate of composite Major Adverse Cardiac Events (MACE) in the Test Arm (cooling + PCI) to the Control Arm (PCI only) at 30-Day follow-up to determine non-inferiority to the Control. Composite MACE is defined as Cardiac Death (CD), All Myocardial Re-Infarction (All MI) and Clinically-Indicated Target Vessel Revascularization (CI-TVR).

  30 Days

Study Arms (2)

Cooling + PCI

OTHER

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.

Device: Intravascular permissive hypothermia as an adjunct to PCI

PCI only

OTHER

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.

Device: Intravascular permissive hypothermia as an adjunct to PCI

Interventions

Intravascular permissive hypothermia as an adjunct to PCI DEVICE

Cooling with ZOLL Proteus IVTM System before and after Percutaneous Coronary Intervention (PCI) -or- Standard of Care for PCI

Cooling + PCI; PCI only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient is ≥ 18 years of age.
• The patient must have symptoms consistent with AMI (i.e. chest pain, arm pain, etc.) and unresponsive to nitroglycerin, with symptoms beginning greater than 30 minutes but less than 6 hours prior to presentation at hospital.
• Qualifying Infarct location:
• Roll-In subjects: Evidence of Acute Anterior or Inferior MI with ST-segment elevation of \>= 0.2 mV in two or more anterior or inferior contiguous precordial leads.
• Randomized subjects: Evidence of Acute Anterior MI only with ST-segment elevation of \>= 0.2 mV in two or more anterior contiguous precordial leads.
• The patient is eligible for PCI.
• The patient is willing to provide written informed consent to participate in this clinical trial.

You may not qualify if:

• The patient has had a previous Myocardial Infarction.
• The patient is experiencing 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 \[IABP\]).
• The patient is presenting with resuscitated cardiac arrest, atrial fibrillation, or Killip risk stratification class II through IV.
• The patient has an aortic dissection or requires an immediate surgical or procedural intervention other than PCI.
• The patient has known history of Congestive Heart Failure (CHF), hepatic failure, end-stage kidney disease or severe renal failure (clearance \< 30ml/min/1.73m²).
• The patient is febrile (temperature \> 37.5 °C) or has experienced an infection with fever in the last 5 days.
• The patient has a known previous CABG.
• The patient has a known recent stroke within 90 days of admission.
• Cardio-pulmonary decompensation that has occurred en route to the hospital or, in the opinion of the physician, that is imminent or likely to occur following presentation to the clinical site.
• 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).The patient has a known hypersensitivity or contraindication to aspirin, heparin, or sensitivity to contrast media, which cannot be adequately pre-medicated.
• Any contraindication to cardiac MRI, or any implant in the upper body which may cause artifacts on cardiac MRI imaging.
• The patient has a known hypersensitivity or contraindication to aspirin, heparin, or sensitivity to contrast media, which cannot be adequately pre-medicated.
• The patient has a known history of bleeding diathesis, coagulopathy, cryoglobulinemia, sickle cell anemia, or will refuse blood transfusions.
• The patient has a height of \<1.5 meters (4 feet 11 inches).
• The patient has a known hypersensitivity or contraindication to buspirone hydrochloride or Pethidine (Meperidine) and/or has been treated with a monoamine oxidase inhibitor in the past 14 days.

Sponsors & Collaborators

• ZOLL Circulation, Inc., USA: lead

Study Sites (1)

University Medical Centre Ljubljana

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The COOL-AMI EU Pivotal Trial enrolled a total of 111 subjects. The study was terminated prematurely after non-cooling related factors were identified as having a significant impact on group differences, including significantly higher total ischemic time and door-to-balloon time in the cooling arm. This early stoppage limits the power of the results to detect a difference between the treatment arms. Further study needs to be done to evaluate the effectiveness of therapeutic hypothermia in STEMI.

Results Point of Contact

• Title: Vice President of Clinical Affairs
• Organization: ZOLL Circulation, Inc.

jcreech@zoll.com

(408) 541-2140

Study Officials

• Marko Noc

  University Medical Center Ljubljana Slovenia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2017
• First Posted: June 1, 2017
• Study Start: April 14, 2017
• Primary Completion: August 22, 2018
• Study Completion: August 31, 2019
• Last Updated: February 16, 2021
• Results First Posted: February 16, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)