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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

Status
Terminated
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00128791
Enrollment
100
Registered
2005-08-10
Start date
2003-01-31
Completion date
2005-04-30
Last updated
2007-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Infarction

Keywords

myocardial infarction, angioplasty, nitric oxide, prevention, acute myocardial infarction

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 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.

Interventions

Sponsors

Soroka University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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
The proportion of patients with TIMI grade 3 flow after the procedure
The combined rate of target vessel revascularization, myocardial infarction or death at 180 days
Length of hospital stay
The proportion of patients with myocardial grade 3 blush after the procedure

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026