Nitroprusside for Prevention of no-Reflow in Primary Angioplasty

Condition(s) targeted: Myocardial Infarction

Intervention: Nitroprusside (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: Soroka University Medical Center

Official(s) and/or principal investigator(s):
Doron Zahger, MD, Principal Investigator, Affiliation: Soroka UMC, Beer-sheva, Israel

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.

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 design: Prevention, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study

Primary outcome:

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:

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

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.

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Soroka University Medical Center, Beer-Sheva 84101, Israel

Starting date: January 2003
Ending date: April 2005
Last updated: May 24, 2007