COOL MI II: Cooling as an Adjunctive Therapy to Percutaneous Intervention in Patients With Acute Myocardial Infarction

March 20, 2008 updated by: Radiant Medical
Coronary heart disease is the single leading cause of death in the United States. In 2000, it was implicated in 681,000 deaths (1 in every 5 deaths). Myocardial infarction (MI) is the major cause of death in patients dying of coronary heart disease, with an estimated incidence of 1.1 million new and recurrent cases per year. It is well established that reperfusion is the most successful treatment for salvaging myocardium during acute infarction. However, despite such treatment, a substantial number of patients still remain at risk of developing large infarcts, with reduced left ventricular function and increased mortality. Therefore, adjunctive therapies that are designed to reduce ischemic metabolism and cellular injury pending successful reperfusion, or to protect myocytes against the undesired effects of reperfusion ("reperfusion injury"), should be beneficial in limiting infarct size. Mild hypothermia is one such potential therapy. This study has been designed to evaluate whether the adjunctive use of mild hypothermia further reduces the extent of heart damage caused by a heart attack.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

225

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
    • Michigan
      • Royal Oak, Michigan, United States, 48073
        • William Beaumont Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The patient is greater than 18 years of age.
  • The patient must have symptoms consistent with acute myocardial infarction (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.
  • Anterior wall MI with ST-segment elevation of ≥ 1 mm in two or more contiguous leads.
  • The patient is eligible for percutaneous coronary intervention (PCI).
  • The expected timing of the treatment pathway for the patient will allow for at least 30 minutes of cooling prior to PCI.
  • The patient or patient legal guardian is willing to provide written, informed consent to participate in this clinical study.

Exclusion Criteria:

  • The patient has had a previous myocardial infarction within one month.
  • 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 has a known hypersensitivity to hypothermia, including a history of Raynaud's disease.
  • 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 or sickle cell anemia, or will refuse blood transfusions.
  • The patient has a height of <1.5 m (4 feet 11 inches).
  • The patient is known to be pregnant or is expected to become pregnant prior to the 1 month follow-up.
  • The patient has a known hypersensitivity to buspirone hydrochloride or meperidine and/or has been treated with a monoamine oxidase inhibitor in the past 14 days.
  • Patient has a known 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 meperidine administration.
  • The patient has an inferior vena cava filter in place.
  • The patient has a pre-MI life expectancy of <1 year due to underlying medical conditions or pre-existing co-morbidities.
  • The patient has a known, unresolved history of drug use or alcohol dependency, or lacks the ability to comprehend or follow instructions.
  • The patient is currently enrolled in the COOL MI trial or in another investigational drug or device trial that has not completed the primary endpoint or that clinically interferes with the COOL MI study endpoints. Note: For the purpose of this protocol, patients involved in extended follow-up trials for products that were investigational but are currently commercially available are not considered enrolled in an investigational trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Equivalent safety profile
Reduction in infarct size (single photon emission computed tomography [SPECT])

Secondary Outcome Measures

Outcome Measure
Reduction in infarct size (creatinine kinase MB [CK-MB], ST- Segment Resolution)
Improvement in left ventricular ejection fraction (LVEF)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radiant Medical

Investigators

  • Principal Investigator: Joseph P Carrozza, MD, Beth Israel Deaconess Medical Center
  • Principal Investigator: Simon R Dixon, MBChB, William Beaumont Hospitals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

November 1, 2005

First Submitted That Met QC Criteria

November 1, 2005

First Posted (Estimate)

November 3, 2005

Study Record Updates

Last Update Posted (Estimate)

March 21, 2008

Last Update Submitted That Met QC Criteria

March 20, 2008

Last Verified

August 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 50-0045

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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