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

This study has been terminated.
Sponsor:
Information provided by:
Radiant Medical
ClinicalTrials.gov Identifier:
NCT00248196
First received: November 1, 2005
Last updated: March 20, 2008
Last verified: August 2007
  Purpose

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.


Condition Intervention Phase
Acute Myocardial Infarction
Device: Reprieve Endovascular Temperature Therapy System
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: COOL MI II: Cooling as an Adjunctive Therapy to Percutaneous Intervention in Patients With Acute Myocardial Infarction

Resource links provided by NLM:


Further study details as provided by Radiant Medical:

Primary Outcome Measures:
  • Reduction in infarct size (single photon emission computed tomography [SPECT])
  • Equivalent safety profile

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

Estimated Enrollment: 225
Study Start Date: October 2005
Study Completion Date: August 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00248196

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
Sponsors and Collaborators
Radiant Medical
Investigators
Principal Investigator: Joseph P Carrozza, MD Beth Israel Deaconess Medical Center
Principal Investigator: Simon R Dixon, MBChB William Beaumont Hospitals
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00248196     History of Changes
Other Study ID Numbers: 50-0045
Study First Received: November 1, 2005
Last Updated: March 20, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 16, 2014