Rapid Intravascular Cooling in Myocardial Infarction as Adjunctive to Percutaneous Coronary Inter… (NCT00417638) | Clinical Trial Compass
CompletedNot Applicable
Rapid Intravascular Cooling in Myocardial Infarction as Adjunctive to Percutaneous Coronary Intervention
Sweden20 participantsStarted 2007-01
Plain-language summary
Rapid MI-ICE-Pilot is designed to demonstrate the safety and efficacy of the Celsius Controlâ„¢ System (CCS) endovascular catheter to reduce the infarct size resulting from acute anterior myocardial infarction when used in combination with cold saline as an adjunct to immediate percutaneous coronary intervention (PCI) in patients with an occluded infarct-related artery.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Have ECG evidence of ongoing acute anterior myocardial infarction, involving a large area of myocardium, as defined by the following ECG criteria: a. Anterior infarct: ST-segment elevation \>0.2mV measured 0.08 sec after the J point in 2 or more anatomically contiguous precordial leads, V1 through V4; and/or \>0.2mV in lead V5 V6
✓. Present to the RAPID MI-ICE site within six (6) hours of the onset of acute cardiac ischemic signs or symptoms (such as chest pain or pressure, arm or jaw pain, dyspnea, nausea/vomiting, or syncope)
✓. Be a candidate for PCI and have PCI planned as the immediate intervention.
✓. Be willing and able to comply with study procedures, including returning for the MRI scan at 4 ±2 days and return for the clinical examination on Day 30
✓. Provide written informed consent prior to the initiation of study-specific procedures
✓. Be in Killips Class I
Exclusion criteria
✕. Age less than eighteen (\<18) years of age
✕. Age greater than seventy-five (\>75) years of age
✕. Are pregnant
✕. Have a suspected aortic dissection
✕. History of a prior anterior myocardial infarct or prior large myocardial infarct.
✕. The suspected etiology of myocardial infarction is primarily related to substance abuse (e.g., cocaine, methamphetamine, etc.)
✕. Acute administration of a thrombolytic agent for the qualifying MI
✕. If (during the screening process) the determination is made by site-study personnel that initiation of cooling prior to diagnostic coronary angiography is technically not feasible for any reason (should the patient be randomized to the Hypothermia Arm), the prospective subject should not be enrolled