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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00502528
Other study ID # BQ123AMI12/06
Secondary ID
Status Completed
Phase Phase 2
First received July 16, 2007
Last updated April 27, 2013
Start date May 2007
Est. completion date August 2012

Study information

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

Clinical Trial 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.


Description:

Background and Objective: Acute coronary syndrome is characterized by compromised blood flow at the epicardial and microvascular levels. We have previously shown that thrombectomy in ST-elevation myocardial infarction (STEMI) accelerates ST-segment resolution, possibly by preventing distal embolization. Therefore, we analyzed the vasoconstrictor concentration of acute coronary thrombi, and found high concentrations of endothelin (ET) which correlated with the magnitude of ST-segment resolution within one hour of percutaneous coronary intervention (PCI). Furthermore, ET-receptor blockade by tezosentan significantly repressed vasoconstriction in an in-vitro model using porcine coronary artery rings incubated with coronary thrombus homogenates extracted from STEMI patients.

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.

Methods: Fifty eligible patients will be randomized to receive periinterventional intravenous BQ-123 or placebo. The primary endpoint of the study will be microvascular function evaluated by cardiac magnetic resonance tomography.


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Placebo
Peri-interventional
BQ-123
Peri-interventional

Locations

Country Name City State
Austria Medical University of Vienna Vienna Vienna-Austria

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

References & Publications (1)

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

Outcome

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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