Cooling as an adjuntive therapy to angioplasty in patients with myocardial infarction.

• Register: REBEC
• Last refreshed on: 29 April 2013
• Main ID: RBR-9vpm9c
• Date of registration: 21/05/2012
• Primary sponsor: ZOLL CIRCULATION INC - Sunnyvale, CA, United States
• Public title: Cooling as an adjuntive therapy to angioplasty in patients with myocardial infarction.
• Scientific title: Cooling as an adjuntive therapy to percutaneous intervention in patients with acute myocardial infarction - "cool-mi incor" - version 2.0, february 2011. - COOL-MI INCOR: COOL-MI INCOR TRIAL
• Date of first enrolment: 01/06/2012
• Target sample size: 70
• Recruitment status: not yet recruiting
• URL: http://www.ensaiosclinicos.gov.br/rg/RBR-9vpm9c/
• Study design: Clinical study, prospective, with two arms, controlled randomized, open, phase 3.

Countries of recruitment

Brazil

Contacts

• Name: Luis Dallan
• Affiliation: InCor - HC-FMUSP

• Name: Luis Dallan
• Affiliation: InCor - HC-FMUSP

Key inclusion & exclusion criteria

Inclusion criteria: 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.
Exclusion criteria: 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.

Age minimum: 18Y
Age maximum: 0
Gender: -

Health Condition(s) or Problem(s) studied

I00-I99

Myocardial Infarct
C14.280.647.500.093
C14.280.647.500.187
C14.280.647.500
I21.9

Intervention(s)

Therapeutic Hypothermia adjunct to primary percutaneous coronary intervention versus primary percutaneous coronary intervention in patients with transmural myocardial infarction. There will be evaluated 70 patients divided into two groups randomly, both being treated with primary angioplasty, and one shall be subjected to hypothermia and the other control group without hypothermia. The expectation is that the study will last around two years, and patients will be evaluated during the first 30 days after surgery and were followed thereafter for a period of one year. At 30 days, all patients will undergo cardiac MRI to assess infarct size and its possible reduction due to hypothermia.

Primary Outcome(s)

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(s)

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.

Secondary ID(s)

0242/11

16568

U1111-1129-1175

Source(s) of Monetary Support

ZOLL CIRCULATION INC - Sunnyvale, CA, United States

Secondary Sponsor(s)

ZOLL CIRCULATION INC - Sunnyvale, CA, United States