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

September 20, 2012 updated by: Ge Junbo, Fudan University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

102

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Zhongshan Hospital Fudan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Drug: Diltiazem
Intracoronary Infusion 400-2000ug
ACTIVE_COMPARATOR: 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.
Drug: Verapamil
Intracoronary Infusion 200-1000ug
ACTIVE_COMPARATOR: 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.
Drug: Nitroglycerin
Intracoronary Infusion 200-1000ug

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (ACTUAL)

April 1, 2009

Study Completion (ACTUAL)

August 1, 2009

Study Registration Dates

First Submitted

July 8, 2008

First Submitted That Met QC Criteria

July 8, 2008

First Posted (ESTIMATE)

July 10, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

September 24, 2012

Last Update Submitted That Met QC Criteria

September 20, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Zhongshan 2006-70

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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