Cooling as an adjuntive therapy to angioplasty in patients with myocardial infarction.
- Conditions
- Myocardial InfarctC14.280.647.500.093C14.280.647.500.187C14.280.647.500I21.9
- Registration Number
- RBR-9vpm9c
- Lead Sponsor
- ZOLL CIRCULATION INC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- not yet recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
Patients aged> 18 years; The patient must have symptoms consistent with acute myocardial infarction (chest pain, or arm pain, etc.) and no improvement with nitroglycerin with onset of symptoms more than 30 minutes but less than six hours before its entry in the emergency room; Anterior wall AMI or less with ST segment elevation> 1 mm in two or more contiguous leads; The patient must be eligible for the PCI; The expected time until the patients undergoing PCI should allow at least 30 minutes of cooling before PCI; The patient or legal guardian of the patient agrees and is willing to sign the informed consent to participate in the clinical study.
The patient had a previous myocardial infarction within one month; The patient has cardiogenic shock (systolic blood pressure (SBP) <80 mmHg and unresponsive to volume or SBP <100 mmHg with vasopressors, or need for an intra-aortic balloon - BIA); The patient has known hypersensitivity to hypothermia, including a history of Raynaud's disease; The patient has known hypersensitivity or contraindication to aspirin, heparin, or hypersensitivity to contrast that can not be adequately premedicated; The patient has known history of blood diathesis, coagulopathy, cryoglobulinemia or sickle cell anemia, or refuse a blood transfusion; The patient has a height <1.5 m (4 feet 11 inches); The patient is known to be pregnant or expect to become pregnant before 1 month of follow-up; The patient has known hypersensitivity to buspirone or meperidine hydrochloride and / or treated with a monoamine oxidase inhibitor in the last 14 days; The patient has known history of hepatic or renal impairment, untreated hypothyroidism, Addison's disease, benign prostatic hypertrophy or urethral stricture, which in the opinion of the physician, would be incompatible with the administration of meperidine; To prevent nephrotoxicity gadolinium, patients with renal failure known as a set Glomerular Filtration Rate of less than 30 cubic centimeters per minute; Patients with vena cava filter; The patient has a life expectancy of pre-MI <1 year due to underlying medical conditions or pre-existing comorbidities; The patient has known history of drug or alcohol addiction, or is unable to understand or follow the instructions; The patient is currently enrolled in the study COOL-MI or other drug research or study device that has not completed the primary endpoint or that clinically interferes with the outcomes of the COOL-MI study INCOR.
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint is the reduction of infarct size compared to the myocardium at risk, studied by magnetic resonance imaging using standard T2 and late enhancement with gadolinium 5 days after AMI, in conjunction with SPECT 30 days after infarction.
- Secondary Outcome Measures
Name Time Method Incidence of major adverse cardiac events (MACE) and death within 30 days. Resolution of ST segment elevation after PCI, the ejection fraction determined by SPECT after 30 days. Evaluation of potential complications related to hypothermia and / or cooling endovascular within 30 days. Sub-analysis of patients with anterior MI.