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Nitroprusside for Prevention of no-Reflow in Primary Angioplasty

Primary Purpose

Myocardial Infarction

Status

Terminated

Phase

Phase 4

Locations

Israel

Study Type

Interventional

Intervention

Nitroprusside

About this trial

This is an interventional prevention trial for Myocardial Infarction focused on measuring myocardial infarction, angioplasty, nitric oxide, prevention, acute myocardial infarction

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Soroka University Medical Center

Outcomes

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

Full Information

NCT ID

NCT00128791

First Posted

August 9, 2005

Last Updated

May 24, 2007

Sponsor

Soroka University Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT00128791

Brief Title

Nitroprusside for Prevention of no-Reflow in Primary Angioplasty

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 Type

Interventional

2. Study Status

Record Verification Date

May 2007

Overall Recruitment Status

Terminated

Study Start Date

January 2003 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

April 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Soroka University Medical Center

4. Oversight

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myocardial Infarction

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

Double

Allocation

Randomized

Enrollment

100 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Nitroprusside

Primary Outcome Measure Information:

Title

The coronary blood flow in the artery undergoing intervention following angioplasty as determined by the corrected Thrombolysis in Myocardial Infarction (TIMI) frame count (CTFC)

Title

Proportion of patients with complete ST-segment resolution immediately after percutaneous coronary intervention (PCI)

Secondary Outcome Measure Information:

Title

The proportion of patients with TIMI grade 3 flow after the procedure

Title

The proportion of patients with myocardial grade 3 blush after the procedure

Title

The proportion of patients with complete ST-segment resolution at 24 hours post intervention

Title

The proportion of patients requiring intra-aortic balloon counter-pulsation and its duration of use

Title

Length of hospital stay

Title

The combined rate of target vessel revascularization, myocardial infarction or death at 180 days

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Doron Zahger, MD

Organizational Affiliation

Soroka UMC, Beer-sheva, Israel

Official's Role

Principal Investigator

Facility Information:

Facility Name

Soroka University Medical Center

City

Beer-Sheva

ZIP/Postal Code

84101

Country

Israel

12. IPD Sharing Statement

Learn more about this trial

Nitroprusside for Prevention of no-Reflow in Primary Angioplasty

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