Endothelin-Receptor Blockade in Coronary Heart Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00427232
Recruitment Status : Completed
First Posted : January 26, 2007
Last Update Posted : January 26, 2007
Information provided by:
Medical University of Vienna

Brief Summary:
Endothelin is a hormon that causes acute and chronic narrowing of heart vessels. The purpose of this study is to assess whether suppression of this activity by using two types of receptor antagonists can reduce this effect and thus improve blood supply of the heart muscle.

Condition or disease Intervention/treatment Phase
Coronary Vessels Endothelins Vascular Resistance Drug: BQ-123 and BQ-788 Phase 1

Detailed Description:

Endothelin (ET) is the most potent vasoconstrictor known and plays a major role in the development of coronary artery disease as well as in acute vasoconstriction. This effect is mainly mediated by the vascular ET-A receptor, whereas the ET-B receptor mediates vasodilation and cleavage of ET. Currently, there are both selective ET-A antagonists and non-selective ET-A and ET-B antagonists under investigation. The aim of the study is to test the effect of ET-receptor blockade on the vasoreagibility of epicardial and intramyocardial coronary arteries in patients undergoing cardiac catheterization. We randomly use the selective ET-A receptor BQ-123 (Group A) and the combination of BQ-123 and the ET-B receptor antagonist BQ-788 (Group B). The tested infusion will be applied selectively into the assessed coronary artery by a special infusion catheter. To evaluate the morphometric changes we use quantitative coronary angiography to measure the diameter of the coronary artery before and after intracoronary infusion of the tested substances. Furthermore we will use Pressure Wire to measure the hemodynamic conditions before and after infusion, thus evaluating the epicardial and the intramyocardial blood perfusion.

Comparison: Coronary artery diameter as measured by quantitative angiography (minimal lumen diameter) and parameters indicative of epicardial and intramyocardial blood flow as determined by Pressure Wire (fractional flow reserver, coronary flow reserve, intramyocardial resistance) before and after ET-antagonist infusion will be compared.

Study Type : Interventional  (Clinical Trial)
Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Diagnostic
Official Title: Selective and Non-Selective Endothelin-Receptor Blockade in Coronary Artey Disease
Study Start Date : May 2003
Study Completion Date : August 2006

Primary Outcome Measures :
  1. minimal lumen diameter measured directly after infusion of the ET-antagonist(s)

Secondary Outcome Measures :
  1. fractional flow reserve, coronary flow reserve, intramyocardial resistance measured directly after infusion of the ET-antagonist(s)

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • coronary artey disease
  • stable angina pectoris
  • male and post-menopausal female patients
  • age above 19 years
  • able and willing to conform to the requirements of the study
  • provided written informed consent

Exclusion Criteria:

  • severe focal coronary stenosis
  • visually calcified stenosis
  • aorto-ostial lesion location and unprotected left main stenosis
  • pre-menopausal female patients
  • diabetes mellitus
  • unstable angina pectoris and/or acute Q-wave myocardial infarctaion within the past 72 hours
  • current vasoactive medication
  • previous percutaneous transluminal revascularization at the site of the target lesion
  • lesion which has extremely angulated segments >90%
  • vessel with escessive tortuosity of the proximal segment
  • severe hypotension
  • severely reduced left ventricular function
  • severe carotid stenosis
  • patients with pace maker
  • patients with elevated liver enzymes
  • patients simultaneously participating in another device or drug study
  • inability of unwillingness to comply with the study protocol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00427232

Dept. of Internal Medicine II, Medical University of Vienna
Vienna, Austria, A-1090
Sponsors and Collaborators
Medical University of Vienna
Principal Investigator: Thomas Neunteufl, MD Dept. of Internal Medicine II, Medical University of Vienna

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00427232     History of Changes
Other Study ID Numbers: EK 242/2002
First Posted: January 26, 2007    Key Record Dates
Last Update Posted: January 26, 2007
Last Verified: January 2007

Keywords provided by Medical University of Vienna:
coronary heart disease
coronary angiography
blood flow velocity
fractional flow reserve, myocardial

Additional relevant MeSH terms:
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Arterial Occlusive Diseases