SAFETY AND FEASIBILITY OF INTRACORONARY HYPOTHERMIA IN ACUTE MYOCARDIAL INFARCTION (SINTAMI)

Completed

Conditions: heart attack
10011082
myocardial infarction

Registration Number: NL-OMON42138

Lead Sponsor: Catharina-ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

Patients will be eligible for this study when they are admitted for acute ST elevation myocardial infarction with a total ST-segment deviation of more than 5 mm and presenting within 6 hours after onset of complaints.
Patients should have a TIMI 0, 1 or 2 flow in the infarction related artery.
If these patients are hemodynamically stable and in an acceptable clinical condition, informed consent will be asked to participate in this study.

Exclusion Criteria

• Age < 18 year
• Cardiogenic shock or pre-shock
• Poor clinical condition with concomitant inconvenience like repeated vomiting, severe chest pain or elsewise according to the judgement of the treating interventionalist.
• Patients with previous myocardial infarction in the culprit area of with previous bypass surgery
• Tortuous coronary arteries
• Complex or long-lasting primary PCI expected
• Severe concomitant disease or conditions with a life expectancy of less than one year
• Inability to understand and give informed consent either in first instance on the table or in second instance on the coronary care unit.
• Other known myocardial diseases, such as moderate or severe left ventricular hypertrophy or cardiomyopathy
• Pregnancy
• Mobitz II block, trifascicular block, or total AV block
• Patients in whom no access to the coronary circulation can be obtained by the
femoral artery or in whom femoral access was problematic

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Feasibility<br /><br>- Is the protocol easily performed by the operators<br /><br>- Is a quick temperature drop achieved<br /><br>- Is it possible to obtain a stable coronary temperature during 30 minutes.<br /><br><br /><br><br /><br>Safety<br /><br>- Is there a higher incidence of rhythm- or conductance disturbances compared<br /><br>with the routine PCI procedure for myocardial infarction or is any other<br /><br>unforeseen side effect observed.</p><br>

Secondary Outcome Measures