Clinical Trial: Nitroprusside for Prevention of no-Reflow in Primary Angioplasty

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Intracoronary Nitroprusside for the Prevention of the No-Reflow Phenomenon Following Primary Percutaneous Coronary Intervention in Acute Myocardial Infarction. A Randomize

Brief Summary: In patients admitted with acute myocardial infarction, there is a total occlusion of a coronary artery. Even after emergency catheterization and angioplasty, in some patients, the resumed blood flow is suboptimal and impacts on heart function. The study is aimed at examining whether nitroprusside, an anti-hypertension medication, given directly into the coronary artery, can improve the blood flow after the removal of the obstruction that caused the infarction.

Detailed Summary: Inadequate myocardial tissue perfusion despite successful relief of the culprit occlusion and restoration of epicardial coronary flow for ST-segment elevation acute myocardial infarction (STEMI) results in poor outcome. The investigators hypothesized that nitroprusside (NTP) injected intracoronary immediately before angioplasty might prevent no-reflow and improve vessel flow and myocardial perfusion.
Sponsor: Soroka University Medical Center

Current Primary Outcome:

  • The coronary blood flow in the artery undergoing intervention following angioplasty as determined by the corrected Thrombolysis in Myocardial Infarction (TIMI) frame count (CTFC)
  • Proportion of patients with complete ST-segment resolution immediately after percutaneous coronary intervention (PCI)


Original Primary Outcome:

  • 1.The coronary blood flow in the artery undergoing intervention following angioplasty as determined by the corrected Thrombolysis In Myocardial Infarction (TIMI) frame counts (CTFC) .
  • 2.Proportion of patients with complete ST segment resolution immediately after PCI.


Current Secondary Outcome:

  • The proportion of patients with TIMI grade 3 flow after the procedure
  • The proportion of patients with myocardial grade 3 blush after the procedure
  • The proportion of patients with complete ST-segment resolution at 24 hours post intervention
  • The proportion of patients requiring intra-aortic balloon counter-pulsation and its duration of use
  • Length of hospital stay
  • The combined rate of target vessel revascularization, myocardial infarction or death at 180 days


Original Secondary Outcome:

  • The proportion of patients with TIMI grade 3 flow after the procedure
  • The proportion of patients with myocardial grade 3 blush after the procedure
  • The proportion of patients with complete ST-segment resolution at 24 hours post intervention
  • The proportion of patients requiring intra-aortic balloon counter-pulsation and its duration of use
  • Length of hospital stay
  • The combined rate of target vessel revascularization, myocardial infarction or death at 180 days.


Information By: Soroka University Medical Center

Dates:
Date Received: August 9, 2005
Date Started: January 2003
Date Completion: April 2005
Last Updated: May 24, 2007
Last Verified: May 2007