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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator | Placebo |
|
| 2 | Active Comparator | BQ-123 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Peri-interventional |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Myocardial perfusion determined by CMR | 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| Final infarct size determined by CMR | 3 days | |
| Left ventricular function determined by CMR | 3 days/ 6 months (6-months Remodeling-substudy) | |
| Plasma NT-BNP |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Irene M Lang, MD | Medical University of Vienna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Vienna | Vienna | Vienna-Austria | 1090 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22522549 | Result | 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 microvasculature: a randomised pilot study. EuroIntervention. 2012 Apr;7(12):1386-95. doi: 10.4244/EIJV7I12A218. |
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| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| D007238 | Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C072247 | cyclo(Trp-Asp-Pro-Val-Leu) |
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| BQ-123 |
| Drug |
Peri-interventional |
|
|
| 30 days/ 6 months (6-months substudy) |
| Enzymatic infarct size (CK levels) | 3 days |
| ECG ST-segment resolution | 1 hour |
| Markers of inflammation | 24 hours/ 30 days |
| Major adverse cardiac events (MACE) (cardiovascular death, re-hospitalization for unstable angina and AMI, hospitalization for worsening heart failure) | 30 days |
| Liver function | 24hours/ 3 days/ 30 days |
| Event free survival | 6 months (6-months substudy) |
| Holter ECG | 3 days / 30 days (EP-substudy) |
| D014652 |
| Vascular Diseases |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |