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

Sponsor:	Fudan University
Information provided by:	Fudan University
ClinicalTrials.gov Identifier:	NCT00712894

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:

MedlinePlus related topics: Heart Attack

Drug Information available for: Nitroglycerin Verapamil hydrochloride Diltiazem hydrochloride Diltiazem Diltiazem malate

U.S. FDA Resources

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 ]

Estimated Enrollment:	100
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

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

No publications provided

Responsible Party:	Ge Junbo, Zhongshan Hospital
ClinicalTrials.gov Identifier:	NCT00712894 History of Changes
Other Study ID Numbers:	Zhongshan 2006-70
Study First Received:	July 8, 2008
Last Updated:	June 22, 2011
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
Diltiazem
Verapamil

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

ClinicalTrials.gov processed this record on May 23, 2012