ENDOTHELIN RECEPTOR BLOCKADE IN ACUTE ST-ELEVATION MYOCARDIAL INFARCTIO

• Conditions: Acute myocardial infarction; MedDRA version: 9.1Level: LLTClassification code 10028596Term: Myocardial infarction

• Registration Number: EUCTR2006-006778-11-AT
• Lead Sponsor: Medical University of Vienna, Department of Internal Medicine II

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03-15
• Last Update Posted: 29 October 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

This study includes STEMI patients (defined as: Evidence of ischemic chest pain for >30 minutes within <12 hours and new ST-segment elevation for =2 mm in two or more contiguous electrocardiographic leads or in case of a true posterior infarction reciprocal ST-segment depressions in in V1 and V2 >1mm and/or elevated serum creatine phosphokinase or twofold elevation of troponin-T), aged 18 years and above, who undergo primary percutaneous revascularization (PCI) and have confirmed initial TIMI 0 or 1 in the infarct related coronary artery.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusion criteria
•Significant liver disease
•History of prior myocardial infarction
•Current atrial fibrillation
•History of congestive heart failure
•History of migraine headache
•Significant valvular heart disease, primary myocardial disease
•Cardiogenic shock (sRR <90mmHg or need for inotropic support)
•Child-bearing potential
•Inability to read, understand and sign the informed consent
•Life expectancy <3y
•Participation in another clinical study
•Metal implants contraindicating CMR

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The aim of the present study is to investigate the effect of ET–receptor blockade by BQ-123 on myocardial perfusion and infarct size as an adjunct to PCI-reperfusion therapy in patients with STEMI.;Secondary Objective: ;Primary end point(s): Myocardial perfusion determined by CMR