Endothelin-Receptor Blockade in Coronary Heart Disease

This study has been completed.
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00427232
First received: January 25, 2007
Last updated: NA
Last verified: January 2007
History: No changes posted
  Purpose

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 Intervention Phase
Coronary Vessels
Endothelins
Vascular Resistance
Drug: BQ-123 and BQ-788
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Diagnostic
Official Title: Selective and Non-Selective Endothelin-Receptor Blockade in Coronary Artey Disease

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

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

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

Estimated Enrollment: 26
Study Start Date: May 2003
Estimated Study Completion Date: August 2006
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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00427232

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

No publications provided by Medical University of Vienna

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00427232     History of Changes
Other Study ID Numbers: EK 242/2002
Study First Received: January 25, 2007
Last Updated: January 25, 2007
Health Authority: Austria: Ethikkommission

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

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

ClinicalTrials.gov processed this record on September 22, 2014