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Endothelin Receptor Blockade in Acute ST-elevation Myocardial Infarction

NCT ID: NCT00502528

Last Updated: 2013-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2012-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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ST-Elevation Myocardial Infarction

Keywords

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Infarction Endothelin Perfusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Peri-interventional

2

BQ-123

Group Type ACTIVE_COMPARATOR

BQ-123

Intervention Type DRUG

Peri-interventional

Interventions

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Placebo

Peri-interventional

Intervention Type DRUG

BQ-123

Peri-interventional

Intervention Type DRUG

Other Intervention Names

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sodium salt Cyclo(-D-Trp-D-Asp-Pro-D-Val-Leu) sodium salt

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Irene Lang

PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Irene M Lang, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Locations

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Medical University of Vienna

Vienna, Vienna-Austria, Austria

Site Status

Countries

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Austria

References

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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.

Reference Type RESULT
PMID: 22522549 (View on PubMed)

Other Identifiers

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BQ123AMI12/06

Identifier Type: -

Identifier Source: org_study_id