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Nitroprusside for Prevention of no-Reflow in Primary Angioplasty

This study has been terminated.
Sponsor:
Information provided by:
Soroka University Medical Center
ClinicalTrials.gov Identifier:
NCT00128791
First received: August 9, 2005
Last updated: May 24, 2007
Last verified: May 2007
History of Changes
  Purpose

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 Intervention Phase
Myocardial Infarction
 Drug: Nitroprusside
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Soroka University Medical Center:

Primary Outcome Measures:
  • 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)

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 100
Study Start Date: January 2003
Estimated Study Completion Date: April 2005
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00128791

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

No publications provided

ClinicalTrials.gov Identifier: NCT00128791     History of Changes
Other Study ID Numbers: sor323102ctil
Study First Received: August 9, 2005
Last Updated: May 24, 2007
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Soroka University Medical Center:
myocardial infarction
angioplasty
nitric oxide
prevention
acute myocardial infarction

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
 Nitroprusside
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Nitric Oxide Donors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents

ClinicalTrials.gov processed this record on May 19, 2013