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Table 3 Endpoints

From: Effect of additional treatment with EXenatide in patients with an Acute Myocardial Infarction (EXAMI): study protocol for a randomized controlled trial

Primary endpoint

Infarct size measured as the final infarct size on delayed contrast enhancement (DCE) MRI at 4 months as a percentage of the area at risk on T2 weighted MRI at 3-7 days.

Secondary endpoints

Myocardial salvage index and final infarct size measured by MRI

 

Regional cardiac function based on echocardiographic and MRI segmental analysis at 2-7 days and at 4 months (for echo) and at 3-7 days and at 4 months (for MRI).

 

Global cardiac functional parameters measured by echocardiography and MRI

 

Myocardial infarct size as measured by serum CK-MB release during the first 72 hours after PCI.

 

Microvascular obstruction measured by DCE MRI 3-7 days after PCI.

 

Blood pressure and heart rate at 1 day, 7 days and at 4 months

 

The occurrence within 4 months of a Major Adverse Cardiac Event (MACE) defined as cardiac death, myocardial infarction, coronary bypass grafting, or a repeat PCI.

 

Repeat PCI in the infarct related artery during 4 months follow up.

 

Plasma glucose levels during the first 72 hours.

 

Side effects of exenatide

 

Angiographic parameters as Thrombolysis in Myocardial Infarction (TIMI) frame count and TIMI blush grade