Nitroprusside for Prevention of no-Reflow in Primary Angioplasty

Sponsor

Soroka University Medical Center (Other)

Overall Status

Terminated

CT.gov ID

NCT00128791

Collaborator

(none)

100

Enrollment

Location

Duration (Months)

3.7

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

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 :

Jan 1, 2003

Study Completion Date :

Apr 1, 2005

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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