Overview

Endothelin Receptor Blockade in Acute ST-elevation Myocardial Infarction

Status:
Completed
Trial end date:
2012-08-01
Target enrollment:
0
Participant gender:
All
Summary
Background and Objective: Acute coronary syndrome is characterized by compromised blood flow at the epicardial and microvascular levels. 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. Patients are randomized to receive periinterventional intravenous BQ-123 or placebo.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Medical University of Vienna
Treatments:
cyclo(Trp-Asp-Pro-Val-Leu)
Criteria
Inclusion Criteria:

- 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.

Exclusion Criteria:

- Significant liver disease

- Thrombolytic therapy

- 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

- Prior organ transplantation

- Medication with konazoles, ritonavir, rifampicin and sulfonyl-urea derivatives

- Participation in another clinical study

- Metal implants contraindicating CMR