Clinical trial NCT00712894: Effects of Different Vasodilators on Coronary No-reflow During primAry percuTaneous Coronary intErvention in Patients With Acute Myocardial Infarction
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Myocardial Infarction
Percutaneous Coronary Intervention
Keywords: Acute myocardial infarction
Percutaneous coronary intervention
No-reflow phenomenon
Vasodilator agents
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2008-07-10
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Vessel flow using TIMI flow grade and TIMI frame count
timeFrame: post-PCI
Secondary outcomes:
measure: major adverse cardiovascular events (MACE)
timeFrame: within the first 30 days after PCI
measure: Left ventricular ejection fraction (LVEF) through echocardiography
timeFrame: at 1 and 30 days post-PCI
measure: NT-proBNP levels
timeFrame: at 1 and 30 days post-PCI
measure: incidence of complete ST-segment resolution
timeFrame: 3 hours after PCI
measure: peak troponin T level
timeFrame: 24 hours after PCI
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University
state: Shanghai
Study officials:
affiliation: Fudan University
name: Junbo Ge, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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):394-401. doi: 10.1016/j.ahj.2012.06.015.