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

Acute Myocardial Infarction Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00712894
• Other study ID #: Zhongshan 2006-70
• Status: Completed
• Phase: Phase 4
• First received: July 8, 2008
• Last updated: September 20, 2012
• Start date: December 2006
• Est. completion date: August 2009

Study information

• Verified date: September 2012
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: August 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of acute myocardial infarction

• Vessel TIMI flow < grade ? post-PCI

Exclusion Criteria:

• Heart failure of New York Heart Association (NYHA) class ? to class ?

• Sick sinus syndrome

• Atrioventricular block (grade ? and above)

• SBP = 90mmHg or cardiogenic shock

• Heart Rate =60 bpm

• Pregnancy

• Renal or hepatic failure

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction
• Percutaneous Coronary Intervention

Intervention

Drug:
• Diltiazem
Intracoronary Infusion 400-2000ug
• Verapamil
Intracoronary Infusion 200-1000ug
• Nitroglycerin
Intracoronary Infusion 200-1000ug

Locations

Country	Name	City	State
China	Zhongshan Hospital Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

References & Publications (1)

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):394-4 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vessel flow using TIMI flow grade and TIMI frame count		post-PCI	Yes
Secondary	major adverse cardiovascular events (MACE)		within the first 30 days after PCI	No
Secondary	Left ventricular ejection fraction (LVEF) through echocardiography		at 1 and 30 days post-PCI	No
Secondary	NT-proBNP levels		at 1 and 30 days post-PCI	No
Secondary	incidence of complete ST-segment resolution		3 hours after PCI	No
Secondary	peak troponin T level		24 hours after PCI	No