Endothelin Receptor Blockade in Acute ST-elevation Myocardial Infarction

April 27, 2013 updated by: Irene Lang, Medical University of Vienna

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
    • Vienna-Austria
      • Vienna, Vienna-Austria, Austria, 1090
        • Medical University of Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 1
Placebo
Drug: Placebo
Peri-interventional
Other Names:
  • sodium salt
Active Comparator: 2
BQ-123
Drug: BQ-123
Peri-interventional
Other Names:
  • Cyclo(-D-Trp-D-Asp-Pro-D-Val-Leu) sodium salt

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Myocardial perfusion determined by CMR
Time Frame: 3 days
3 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Final infarct size determined by CMR
Time Frame: 3 days
3 days
Left ventricular function determined by CMR
Time Frame: 3 days/ 6 months (6-months Remodeling-substudy)
3 days/ 6 months (6-months Remodeling-substudy)
Plasma NT-BNP
Time Frame: 30 days/ 6 months (6-months substudy)
30 days/ 6 months (6-months substudy)
Enzymatic infarct size (CK levels)
Time Frame: 3 days
3 days
ECG ST-segment resolution
Time Frame: 1 hour
1 hour
Markers of inflammation
Time Frame: 24 hours/ 30 days
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
30 days
Liver function
Time Frame: 24hours/ 3 days/ 30 days
24hours/ 3 days/ 30 days
Event free survival
Time Frame: 6 months (6-months substudy)
6 months (6-months substudy)
Holter ECG
Time Frame: 3 days / 30 days (EP-substudy)
3 days / 30 days (EP-substudy)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

July 16, 2007

First Submitted That Met QC Criteria

July 16, 2007

First Posted (Estimate)

July 17, 2007

Study Record Updates

Last Update Posted (Estimate)

April 30, 2013

Last Update Submitted That Met QC Criteria

April 27, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BQ123AMI12/06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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