Efficacy of Endovascular Catheter Cooling Combined With Cold Saline for the Treatment of Acute My… (NCT01379261) | Clinical Trial Compass
CompletedPhase 2/3
Efficacy of Endovascular Catheter Cooling Combined With Cold Saline for the Treatment of Acute Myocardial Infarction
Austria, Denmark120 participantsStarted 2011-06
Plain-language summary
The purpose of this study is to determine whether treatment of patients suffering from ST-elevation myocardial infarction (STEMI) with 1-2 liters of cold saline and central venous catheter cooling with Philips InnerCool RTx Endovascular System prior to percutaneous coronary intervention (PCI) result in a reduction in infarct size.
Who can participate
Age range18 Years – 79 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Clinical symptoms and signs of myocardial infarction and have a 12-lead ECG providing evidence of an ongoing acute myocardial infarction, involving a large area of myocardium, as defined by the following ECG criteria. The ECG changes should be present upon arrival to the cath lab:
✓. 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.
✓. Inferior infarct: ST elevation \>0.2mV measured 0.08 sec after the J point in 2 or more anatomically contiguous inferior leads, coupled with ST depression in 2 contiguous anterior leads for a total ST deviation (inferior ST elevation plus anterior ST depression) of \>0.8mV.
✓. Present to the study PCI lab 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 be available for additional follow up Subject understands study procedures and agrees to participate in the study by giving written informed consent.
✓. Be in Killips Class I.
Exclusion criteria
✕. Age less than eighteen (\<18) years of age
✕. Age greater than or equal to eighty (80) years of age
What they're measuring
1
Myocardial infarct size (as a percentage of myocardium at risk) assessed by cardiac MRI.
✕. History of a prior large myocardial infarct or an infarct in the same segment that is currently affected.
✕. Acute administration of a thrombolytic agent for the qualifying MI
✕. Clinical suspicion of a non-thrombotic (e.g., pericarditis, vasospasm, takotsubo, illicit drug use) cause for ST-segment elevation as determined by the investigator
✕. 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.