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:
Information provided by (Responsible Party):
Ge Junbo, Fudan University
ClinicalTrials.gov Identifier:
NCT00712894
First received: July 8, 2008
Last updated: September 20, 2012
Last verified: September 2012
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 Fudan University:

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

Secondary Outcome Measures:
  • major adverse cardiovascular events (MACE) [ Time Frame: within the first 30 days after PCI ] [ Designated as safety issue: No ]
  • Left ventricular ejection fraction (LVEF) through echocardiography [ Time Frame: at 1 and 30 days post-PCI ] [ Designated as safety issue: No ]
  • NT-proBNP levels [ Time Frame: at 1 and 30 days post-PCI ] [ Designated as safety issue: No ]
  • incidence of complete ST-segment resolution [ Time Frame: 3 hours after PCI ] [ Designated as safety issue: No ]
  • peak troponin T level [ Time Frame: 24 hours after PCI ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: July 8, 2008
Last Updated: September 20, 2012
Health Authority: China: Ministry of Health

Keywords provided by 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
Verapamil
Diltiazem
Nitroglycerin
Vasodilator Agents
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents

ClinicalTrials.gov processed this record on August 25, 2014