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

Fudan University

Status and phase: Completed; Phase 4

Conditions: Percutaneous Coronary Intervention; Acute Myocardial Infarction

Treatments: Drug: Diltiazem; Drug: Nitroglycerin; Drug: Verapamil

Study type: Interventional

Funder types: Other

Identifiers

NCT00712894

Zhongshan 2006-70

Details and patient eligibility

About

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.

Full 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.

Enrollment: 102 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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102 participants in 3 patient groups

D

Experimental group

Description:

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.

Treatment:

Drug: Diltiazem

V

Active Comparator group

Description:

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.

Treatment:

Drug: Verapamil

N

Active Comparator group

Description:

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.

Treatment:

Drug: Nitroglycerin