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

Phase 4

Completed

• Conditions: Acute Myocardial Infarction; Percutaneous Coronary Intervention
• Interventions: Drug: Nitroglycerin; Drug: Diltiazem; Drug: Verapamil

• Registration Number: NCT00712894
• Lead Sponsor: Fudan University

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.

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2008-07-08
• Study First Submitted QC: 2008-07-08
• Study First Posted: 2008-07-10
• Primary Completion: 2009-04
• Study Completion: 2009-08
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-20
• Last Update Posted: 2012-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
N	Nitroglycerin	If no-reflow/slow-flow phenomenon was observed post-PCI, intracoronary infusion of nitroglycerin via an infusion microcatheter distal to the angioplasty site was performed.
D	Diltiazem	If no-reflow/slow-flow phenomenon was observed post-PCI, intracoronary infusion of diltiazem via an infusion microcatheter distal to the angioplasty site was performed.
V	Verapamil	If no-reflow/slow-flow phenomenon was observed post-PCI, intracoronary infusion of verapamil via an infusion microcatheter distal to the angioplasty site was performed.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Zhongshan Hospital Fudan University; 🇨🇳 Shanghai, Shanghai, China