Nitroprusside for Prevention of no-Reflow in Primary Angioplasty

Myocardial Infarction Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00128791
• Other study ID #: sor323102ctil
• Status: Terminated
• Phase: Phase 4
• First received: August 9, 2005
• Last updated: May 24, 2007
• Start date: January 2003
• Est. completion date: April 2005

Study information

• Verified date: May 2007
• Source: Soroka University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. completion date: April 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Drug:
• Nitroprusside

Locations

Country	Name	City	State
Israel	Soroka University Medical Center	Beer-Sheva

Sponsors (1)

Lead Sponsor	Collaborator
Soroka University Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The coronary blood flow in the artery undergoing intervention following angioplasty as determined by the corrected Thrombolysis in Myocardial Infarction (TIMI) frame count (CTFC)
Primary	Proportion of patients with complete ST-segment resolution immediately after percutaneous coronary intervention (PCI)
Secondary	The proportion of patients with TIMI grade 3 flow after the procedure
Secondary	The proportion of patients with myocardial grade 3 blush after the procedure
Secondary	The proportion of patients with complete ST-segment resolution at 24 hours post intervention
Secondary	The proportion of patients requiring intra-aortic balloon counter-pulsation and its duration of use
Secondary	Length of hospital stay
Secondary	The combined rate of target vessel revascularization, myocardial infarction or death at 180 days