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Nitroprusside for Prevention of no-Reflow in Primary Angioplasty

NCT ID: NCT00128791

Last Updated: 2007-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2005-04-30

Brief Summary

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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

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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.

Conditions

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Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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Nitroprusside

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Soroka University Medical Center

OTHER

Sponsor Role lead

Principal Investigators

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Doron Zahger, MD

Role: PRINCIPAL_INVESTIGATOR

Soroka UMC, Beer-sheva, Israel

Locations

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Soroka University Medical Center

Beersheba, , Israel

Site Status

Countries

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Israel

Other Identifiers

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sor323102ctil

Identifier Type: -

Identifier Source: org_study_id