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Nitroprusside for Prevention of no-Reflow in Primary Angioplasty

S

Soroka University Medical Center

Status and phase

Terminated
Phase 4

Conditions

Myocardial Infarction

Treatments

Drug: Nitroprusside

Study type

Interventional

Funder types

Other

Identifiers

NCT00128791
sor323102ctil

Details and patient eligibility

About

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.

Full 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.

Sex

All

Volunteers

No 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Double Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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