Nitroprusside for Prevention of no-Reflow in Primary Angioplasty
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
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jan 2003
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 9, 2005
CompletedFirst Posted
Study publicly available on registry
August 10, 2005
CompletedMay 25, 2007
May 1, 2007
August 9, 2005
May 24, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (6)
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
- +1 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Soroka University Medical Center
Beersheba, 84101, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Doron Zahger, MD
Soroka UMC, Beer-sheva, Israel
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 9, 2005
First Posted
August 10, 2005
Study Start
January 1, 2003
Study Completion
April 1, 2005
Last Updated
May 25, 2007
Record last verified: 2007-05