Effects of Different Vasodilators on Coronary No-reflow During primAry percuTaneous Coronary intErvention in Patients With Acute Myocardial Infarction
Information source: Fudan University
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Myocardial Infarction; Percutaneous Coronary Intervention
Intervention: Diltiazem (Drug); Verapamil (Drug); Nitroglycerin (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Fudan University Official(s) and/or principal investigator(s):
Junbo Ge, M.D., Principal Investigator, Affiliation: Zhongshan Hospital Fudan University
Overall contact:
Dong Huang, M.D., Phone: 86-21-64041990, Ext: 2728, Email: huang.dong@zs-hospital.sh.cn
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.
Clinical Details
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 design: Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Vessel flow using TIMI flow grade and TIMI frame count
Secondary outcome: major adverse cardiovascular events (MACE)Left ventricular ejection fraction (LVEF) through echocardiography NT-proBNP levels
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
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
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
Locations and Contacts
Dong Huang, M.D., Phone: 86-21-64041990, Ext: 2728, Email: huang.dong@zs-hospital.sh.cn
Zhongshan Hospital Fudan University, Shanghai 200032, China; Recruiting
Dong Huang, M.D., Phone: 86-21-64041990, Ext: 2728, Email: huang.dong@zs-hospital.sh.cn
Additional Information
Starting date: December 2006
Ending date: August 2009
Last updated: August 3, 2009
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