Effects of Different Vasodilators on Coronary No-reflow During primAry percuTaneous Coronary intErvention in Patients With Acute Myocardial Infarction

Reversal of No-reflow/Slow-flow During Percutaneous Coronary Intervention in Patients With Acute Myocardial Infarction--a Prospective Randomized Study Comparing Intracoronary Infusion of Diltiazem, Verapamil and Nitroglycerin

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00712894

Acronym

EDUCATE-AMI

Enrollment

102

Registered

2008-07-10

Start date

2006-12-31

Completion date

2009-08-31

Last updated

2012-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myocardial Infarction, Percutaneous Coronary Intervention

Keywords

Acute myocardial infarction, Percutaneous coronary intervention, No-reflow phenomenon, Vasodilator agents

Brief summary

The purpose of this study is to evaluate the efficacy of three different vasodilators including diltiazem, verapamil and nitroglycerin for reversal of no-reflow/slow-flow during direct percutaneous coronary intervention for acute myocardial infarction.

Detailed description

No-reflow/slow-flow is a frequent observation during direct PCI for AMI and associated with a poor clinical outcome. The present pharmacological management involves the use of different vasodilators including nitrates, verapamil, adenosine and nicorandil. But no randomized trial has been conducted to assess any of these agents, or to determine the appropriate dosage. This prospective randomized study aimed to confirm favorable effects of diltiazem on no-reflow/slow-flow during direct PCI for AMI compared with verapamil and nitroglycerin.

Interventions

DRUGDiltiazem

Intracoronary Infusion 400-2000ug

DRUGVerapamil

Intracoronary Infusion 200-1000ug

DRUGNitroglycerin

Intracoronary Infusion 200-1000ug

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Clinical diagnosis of acute myocardial infarction * Vessel TIMI flow \< grade Ⅲ post-PCI

Exclusion criteria

* Heart failure of New York Heart Association (NYHA) class Ⅲ to class Ⅳ * Sick sinus syndrome * Atrioventricular block (grade Ⅱ and above) * SBP ≤ 90mmHg or cardiogenic shock * Heart Rate ≤60 bpm * Pregnancy * Renal or hepatic failure

Design outcomes

Primary

Measure	Time frame
Vessel flow using TIMI flow grade and TIMI frame count	post-PCI

Secondary

Measure	Time frame
major adverse cardiovascular events (MACE)	within the first 30 days after PCI
Left ventricular ejection fraction (LVEF) through echocardiography	at 1 and 30 days post-PCI
NT-proBNP levels	at 1 and 30 days post-PCI
incidence of complete ST-segment resolution	3 hours after PCI
peak troponin T level	24 hours after PCI

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026