Postconditioning in Primary PCI and Direct Stenting

Myocardial Infarction Clinical Trial

Official title: Clinical and MRI Evaluation of 2 Vs 4 Cycles of Postconditioning During Primary PCI With Direct Stenting

Status Not yet recruiting

Clinical Trial Summary

To determine the safety and efficacy of 2 vs 4 cycles of postconditioning method during primary PCI and direct stenting in acute MI, and to compared to primary PCI and direct stenting without the postconditioning.

Clinical Trial Description

Sample size: 45 subjects

Site Locations: Sheba medical center

Patients: Patients presenting with an acute MI with onset of symptoms  6h, and planned to undergo primary PCI will be included. The target lesion should be located in the proximal or middle segment of a main native coronary artery, and should be suitable for percutaneous intervention.

Primary Objective: To determine the safety and efficacy of 2 vs 4 cycles of postconditioning method during primary PCI and direct stenting in acute MI, and to compared to primary PCI and direct stenting without the postconditioning.

Primary Endpoint:

• ST segment resolution.

• Segmental wall motion score, resolution of edema and wall thickness by echocardiography.

• Infarct size estimation by cardiac enzymes and cardiac MRI.

Secondary endpoints:

• Composite endpoint of Major Adverse Cardiac Events (MACE) at 30 and 90 days

Methods:

• ECG at baseline, immediately after procedure, 90 and 180 minutes after the procedure and 6-24 hours after intervention.

• Core laboratory angiography measurements of TIMI flow, corrected TIMI Frame count, myocardial blush score and left ventricular angiography.

• Myocardial enzymes measurements: every 4 hours in the first 24 hours and every 6 hours in the following 48 hours.

• Left ventricular ejection fraction and wall motion score determined by echocardiography.

• Cardiac MRI estimation of infarct size. • Clinical follow-up at 30 and 90 days post procedure.

Follow-up:

• Follow up at 30 days: Clinical.

• Clinical Follow up & Cardiac MRI at 90 days. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

• NCT number: NCT00351247
• Study type: Interventional
• Source: Sheba Medical Center
• Contact: Victor Guetta, MD
• Phone: 972-52-6667127
• Email: victor.Guetta@health.sheba.gov.il
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2006
• Completion date: May 2007