Endothelin Receptor Blockade in Acute ST-elevation Myocardial Infarction
|ClinicalTrials.gov Identifier: NCT00502528|
Recruitment Status : Completed
First Posted : July 17, 2007
Last Update Posted : April 30, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|ST-Elevation Myocardial Infarction||Drug: Placebo Drug: BQ-123||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||57 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Endothelin Receptor Blockade in Acute ST-elevation Myocardial Infarction|
|Study Start Date :||May 2007|
|Actual Primary Completion Date :||August 2009|
|Actual Study Completion Date :||August 2012|
Placebo Comparator: 1
Other Name: sodium salt
Active Comparator: 2
Other Name: Cyclo(-D-Trp-D-Asp-Pro-D-Val-Leu) sodium salt
- Myocardial perfusion determined by CMR [ Time Frame: 3 days ]
- Final infarct size determined by CMR [ Time Frame: 3 days ]
- Left ventricular function determined by CMR [ Time Frame: 3 days/ 6 months (6-months Remodeling-substudy) ]
- Plasma NT-BNP [ Time Frame: 30 days/ 6 months (6-months substudy) ]
- Enzymatic infarct size (CK levels) [ Time Frame: 3 days ]
- ECG ST-segment resolution [ Time Frame: 1 hour ]
- Markers of inflammation [ Time Frame: 24 hours/ 30 days ]
- Major adverse cardiac events (MACE) (cardiovascular death, re-hospitalization for unstable angina and AMI, hospitalization for worsening heart failure) [ Time Frame: 30 days ]
- Liver function [ Time Frame: 24hours/ 3 days/ 30 days ]
- Event free survival [ Time Frame: 6 months (6-months substudy) ]
- Holter ECG [ Time Frame: 3 days / 30 days (EP-substudy) ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00502528
|Medical University of Vienna|
|Vienna, Vienna-Austria, Austria, 1090|
|Principal Investigator:||Irene M Lang, MD||Medical University of Vienna|