Clinical Trial: Effects of Different Vasodilators on Coronary No-reflow During primAry percuTaneous Coronary intErvention in Patients With Acute Myocardial Infarction

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Reversal of No-reflow/Slow-flow During Percutaneous Coronary Intervention in Patients With Acute Myocardial Infarction--a Prospective Randomized Study Comparing Intracoronary Infusion of Diltiazem, Ve

Brief Summary: The purpose of this study is to evaluate the efficacy of three different vasodilators including diltiazem, verapamil and nitroglycerin for reversal of no-reflow/slow-flow during direct percutaneous coronary intervention for acute myocardial infarction.

Detailed Summary: No-reflow/slow-flow is a frequent observation during direct PCI for AMI and associated with a poor clinical outcome. The present pharmacological management involves the use of different vasodilators including nitrates, verapamil, adenosine and nicorandil. But no randomized trial has been conducted to assess any of these agents, or to determine the appropriate dosage. This prospective randomized study aimed to confirm favorable effects of diltiazem on no-reflow/slow-flow during direct PCI for AMI compared with verapamil and nitroglycerin.
Sponsor: Fudan University

Current Primary Outcome: Vessel flow using TIMI flow grade and TIMI frame count [ Time Frame: post-PCI ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • major adverse cardiovascular events (MACE) [ Time Frame: within the first 30 days after PCI ]
  • Left ventricular ejection fraction (LVEF) through echocardiography [ Time Frame: at 1 and 30 days post-PCI ]
  • NT-proBNP levels [ Time Frame: at 1 and 30 days post-PCI ]
  • incidence of complete ST-segment resolution [ Time Frame: 3 hours after PCI ]
  • peak troponin T level [ Time Frame: 24 hours after PCI ]


Original Secondary Outcome: major adverse cardiovascular events (MACE) [ Time Frame: within the first 30 days after PCI ]

Information By: Fudan University

Dates:
Date Received: July 8, 2008
Date Started: December 2006
Date Completion:
Last Updated: September 20, 2012
Last Verified: September 2012