Back to results

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

Primary Purpose

Acute Myocardial Infarction, Percutaneous Coronary Intervention

Status

Completed

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Diltiazem

Verapamil

Nitroglycerin

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring Acute myocardial infarction, Percutaneous coronary intervention, No-reflow phenomenon, Vasodilator agents

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Zhongshan Hospital Fudan University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Arm 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.

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.

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.

Outcomes

Primary Outcome Measures

Vessel flow using TIMI flow grade and TIMI frame count

Secondary Outcome Measures

major adverse cardiovascular events (MACE)

Left ventricular ejection fraction (LVEF) through echocardiography

NT-proBNP levels

incidence of complete ST-segment resolution

peak troponin T level

Full Information

NCT ID

NCT00712894

First Posted

July 8, 2008

Last Updated

September 20, 2012

Sponsor

Fudan University

1. Study Identification

Unique Protocol Identification Number

NCT00712894

Brief Title

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

Acronym

EDUCATE-AMI

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2012

Overall Recruitment Status

Completed

Study Start Date

December 2006 (undefined)

Primary Completion Date

April 2009 (Actual)

Study Completion Date

August 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fudan University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Myocardial Infarction, Percutaneous Coronary Intervention

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

102 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm 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.

Arm Title

Arm Type

Active Comparator

Arm 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.

Arm Title

Arm Type

Active Comparator

Arm 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.

Intervention Type

Drug

Intervention Name(s)

Diltiazem

Intervention Description

Intracoronary Infusion 400-2000ug

Intervention Type

Drug

Intervention Name(s)

Verapamil

Intervention Description

Intracoronary Infusion 200-1000ug

Intervention Type

Drug

Intervention Name(s)

Nitroglycerin

Intervention Description

Intracoronary Infusion 200-1000ug

Primary Outcome Measure Information:

Title

Vessel flow using TIMI flow grade and TIMI frame count

Time Frame

post-PCI

Secondary Outcome Measure Information:

Title

major adverse cardiovascular events (MACE)

Time Frame

within the first 30 days after PCI

Title

Left ventricular ejection fraction (LVEF) through echocardiography

Time Frame

at 1 and 30 days post-PCI

Title

NT-proBNP levels

Time Frame

at 1 and 30 days post-PCI

Title

incidence of complete ST-segment resolution

Time Frame

3 hours after PCI

Title

peak troponin T level

Time Frame

24 hours after PCI

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Junbo Ge, M.D.

Organizational Affiliation

Fudan University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Zhongshan Hospital Fudan University

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

22980307

Citation

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.

Results Reference

result

Learn more about this trial

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

We'll reach out to this number within 24 hrs