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Sponsored by: |
Radiant Medical |
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Information provided by: | Radiant Medical |
ClinicalTrials.gov Identifier: | NCT00248196 |
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 II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | COOL MI II: Cooling as an Adjunctive Therapy to Percutaneous Intervention in Patients With Acute Myocardial Infarction |
Estimated Enrollment: | 225 |
Study Start Date: | October 2005 |
Study Completion Date: | August 2007 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Principal Investigator: | Joseph P Carrozza, MD | Beth Israel Deaconess Medical Center |
Principal Investigator: | Simon R Dixon, MBChB | William Beaumont Hospitals |
Study ID Numbers: | 50-0045 |
Study First Received: | November 1, 2005 |
Last Updated: | March 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00248196 |
Health Authority: | United States: Food and Drug Administration |
Necrosis Heart Diseases Myocardial Ischemia Vascular Diseases |
Ischemia Infarction Myocardial Infarction |
Pathologic Processes Cardiovascular Diseases |