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Completed

NCT Number: NCT00712894

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

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.

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Key information

Conditions

Acute Myocardial Infarction Ischemia No-Reflow Phenomenon Pathologic Processes Pathological Conditions, Signs and Symptoms Percutaneous Coronary Intervention

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, 200032, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diltiazem

Drug

Intracoronary Infusion 400-2000ug

Verapamil

Drug

Intracoronary Infusion 200-1000ug

Nitroglycerin

Drug

Intracoronary Infusion 200-1000ug

Primary outcomes

  1. Vessel flow using TIMI flow grade and TIMI frame count

    Time frame: post-PCI

Secondary outcomes

  1. major adverse cardiovascular events (MACE)

    Time frame: within the first 30 days after PCI

  2. Left ventricular ejection fraction (LVEF) through echocardiography

    Time frame: at 1 and 30 days post-PCI

  3. NT-proBNP levels

    Time frame: at 1 and 30 days post-PCI

  4. incidence of complete ST-segment resolution

    Time frame: 3 hours after PCI

  5. peak troponin T level

    Time frame: 24 hours after PCI

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study 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

Acronym: EDUCATE-AMI

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Jul 10, 2008
Registry last updated
Sep 24, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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