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Nitroprusside for Prevention of no-Reflow in Primary Angioplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00128791
Recruitment Status : Terminated
First Posted : August 10, 2005
Last Update Posted : May 25, 2007
Information provided by:
Soroka University Medical Center

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.

Condition or disease Intervention/treatment Phase
Myocardial Infarction Drug: Nitroprusside Phase 4

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Intracoronary Nitroprusside for the Prevention of the No-Reflow Phenomenon Following Primary Percutaneous Coronary Intervention in Acute Myocardial Infarction. A Randomized, Double Blind, Placebo-Controlled Clinical Trial
Study Start Date : January 2003
Study Completion Date : April 2005

Resource links provided by the National Library of Medicine

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Acute ST elevation myocardial infarction (MI) patients planned for primary PCI
  • Diagnostic angiography demonstrating a TIMI flow grade <3 in the coronary artery before the PCI

Exclusion Criteria:

  • An admission electrocardiogram (ECG) showing complete left bundle branch block or a paced rhythm
  • Systolic blood pressure < 90 mmHg
  • A history of coronary bypass operation
  • A known allergic reaction to nitroprusside
  • Chronic hemodialysis
  • Intravenous drug abuse
  • Pregnancy
  • Rescue intervention after failed thrombolysis
  • Contraindications to aspirin or clopidogrel
  • Need for emergent coronary artery bypass surgery
  • Inability to provide informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00128791

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Soroka University Medical Center
Beer-Sheva, Israel, 84101
Sponsors and Collaborators
Soroka University Medical Center
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Principal Investigator: Doron Zahger, MD Soroka UMC, Beer-sheva, Israel

Layout table for additonal information Identifier: NCT00128791    
Other Study ID Numbers: sor323102ctil
First Posted: August 10, 2005    Key Record Dates
Last Update Posted: May 25, 2007
Last Verified: May 2007
Keywords provided by Soroka University Medical Center:
myocardial infarction
nitric oxide
acute myocardial infarction
Additional relevant MeSH terms:
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Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Antihypertensive Agents
Vasodilator Agents
Nitric Oxide Donors
Molecular Mechanisms of Pharmacological Action