ST-Elevation Myocardial Infarction Clinical Trial
Official title:
Endothelin Receptor Blockade in Acute ST-elevation Myocardial Infarction
Verified date | April 2013 |
Source | Medical University of Vienna |
Contact | n/a |
Is FDA regulated | No |
Health authority | Austria: Agency for Health and Food Safety |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 57 |
Est. completion date | August 2012 |
Est. primary completion date | August 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Austria | Medical University of Vienna | Vienna | Vienna-Austria |
Lead Sponsor | Collaborator |
---|---|
Medical University of Vienna |
Austria,
Adlbrecht C, Andreas M, Redwan B, Distelmaier K, Mascherbauer J, Kaider A, Wolzt M, Tilea IA, Neunteufl T, Delle-Karth G, Maurer G, Lang IM. Systemic endothelin receptor blockade in ST-segment elevation acute coronary syndrome protects the microvasculatur — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Myocardial perfusion determined by CMR | 3 days | No | |
Secondary | Final infarct size determined by CMR | 3 days | No | |
Secondary | Left ventricular function determined by CMR | 3 days/ 6 months (6-months Remodeling-substudy) | No | |
Secondary | Plasma NT-BNP | 30 days/ 6 months (6-months substudy) | No | |
Secondary | Enzymatic infarct size (CK levels) | 3 days | No | |
Secondary | ECG ST-segment resolution | 1 hour | No | |
Secondary | Markers of inflammation | 24 hours/ 30 days | No | |
Secondary | Major adverse cardiac events (MACE) (cardiovascular death, re-hospitalization for unstable angina and AMI, hospitalization for worsening heart failure) | 30 days | Yes | |
Secondary | Liver function | 24hours/ 3 days/ 30 days | Yes | |
Secondary | Event free survival | 6 months (6-months substudy) | Yes | |
Secondary | Holter ECG | 3 days / 30 days (EP-substudy) | Yes |
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