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

Study Overview
=================
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.

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

Conditions
-----------------
Acute Myocardial Infarction, Percutaneous Coronary Intervention

Intervention / Treatment
-----------------
* Drug: Diltiazem
* Drug: Verapamil
* Drug: Nitroglycerin


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: D<br>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<br>* Intracoronary Infusion 400-2000ug<br>|
| Active Comparator: V<br>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<br>* Intracoronary Infusion 200-1000ug<br>|
| Active Comparator: N<br>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<br>* Intracoronary Infusion 200-1000ug<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vessel flow using TIMI flow grade and TIMI frame count |  | post-PCI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| major adverse cardiovascular events (MACE) |  | within the first 30 days after PCI | 
| Left ventricular ejection fraction (LVEF) through echocardiography |  | at 1 and 30 days post-PCI | 
| NT-proBNP levels |  | at 1 and 30 days post-PCI | 
| incidence of complete ST-segment resolution |  | 3 hours after PCI | 
| peak troponin T level |  | 24 hours after PCI | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute myocardial infarction, Percutaneous coronary intervention, No-reflow phenomenon, Vasodilator agents