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

NCT ID: NCT00712894

Last Updated: 2012-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2009-08-31

Brief Summary

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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

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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.

Conditions

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Acute Myocardial Infarction Percutaneous Coronary Intervention

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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D

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.

Group Type EXPERIMENTAL

Diltiazem

Intervention Type DRUG

Intracoronary Infusion 400-2000ug

V

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.

Group Type ACTIVE_COMPARATOR

Verapamil

Intervention Type DRUG

Intracoronary Infusion 200-1000ug

N

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.

Group Type ACTIVE_COMPARATOR

Nitroglycerin

Intervention Type DRUG

Intracoronary Infusion 200-1000ug

Interventions

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Diltiazem

Intracoronary Infusion 400-2000ug

Intervention Type DRUG

Verapamil

Intracoronary Infusion 200-1000ug

Intervention Type DRUG

Nitroglycerin

Intracoronary Infusion 200-1000ug

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Ge Junbo

Director of Cardiology Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Junbo Ge, M.D.

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

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Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

References

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Huang D, Qian J, Ge L, Jin X, Jin H, Ma J, Liu Z, Zhang F, Dong L, Wang X, Yao K, Ge J. REstoration of COronary flow in patients with no-reflow after primary coronary interVEntion of acute myocaRdial infarction (RECOVER). Am Heart J. 2012 Sep;164(3):394-401. doi: 10.1016/j.ahj.2012.06.015.

Reference Type RESULT
PMID: 22980307 (View on PubMed)

Other Identifiers

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Zhongshan 2006-70

Identifier Type: -

Identifier Source: org_study_id