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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00712894
First Posted: July 10, 2008
Last Update Posted: September 24, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ge Junbo, Fudan University
  Purpose
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.

Condition Intervention Phase
Acute Myocardial Infarction Percutaneous Coronary Intervention Drug: Diltiazem Drug: Verapamil Drug: Nitroglycerin Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Ge Junbo, Fudan University:

Primary Outcome Measures:
  • Vessel flow using TIMI flow grade and TIMI frame count [ Time Frame: post-PCI ]

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

Enrollment: 102
Study Start Date: December 2006
Study Completion Date: August 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00712894


Locations
China, Shanghai
Zhongshan Hospital Fudan University
Shanghai, Shanghai, China, 200032
Sponsors and Collaborators
Fudan University
Investigators
Principal Investigator: Junbo Ge, M.D. Fudan University
  More Information

Publications:
Responsible Party: Ge Junbo, Director of Cardiology Department, Fudan University
ClinicalTrials.gov Identifier: NCT00712894     History of Changes
Other Study ID Numbers: Zhongshan 2006-70
First Submitted: July 8, 2008
First Posted: July 10, 2008
Last Update Posted: September 24, 2012
Last Verified: September 2012

Keywords provided by Ge Junbo, Fudan University:
Acute myocardial infarction
Percutaneous coronary intervention
No-reflow phenomenon
Vasodilator agents

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Nitroglycerin
Verapamil
Diltiazem
Vasodilator Agents
Anti-Arrhythmia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents