The Contribution of Endothelin to Vasomotor Function in Diseased Coronary Arteries

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: NCT00115583
Recruitment Status : Completed
First Posted : June 24, 2005
Last Update Posted : December 9, 2016
Information provided by:
Brigham and Women's Hospital

Brief Summary:
The purpose of the study is to assess the importance of a substance called endothelin. Endothelin is produced by coronary arteries. This study examines this substance to determine whether it has an effect on controlling blood flow in coronary arteries. When these arteries release too much endothelin, the blood flow to the heart muscle is reduced and this may be important in heart conditions. This protocol examines an investigational drug called BQ-123 to see if it blocks the effect of endothelin. We assess the blood flow in the coronaries and evaluate the effects of BQ-123. It is anticipated that this endothelin blocker will open up coronary arteries and increase the blood flow to the heart.

Condition or disease Intervention/treatment Phase
Atherosclerosis, Coronary Drug: Drug Infusion (BQ-123) Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: The Contribution of Endothelin to Vasoreactivity in Atherosclerotic Coronary Arteries
Study Start Date : November 1998
Actual Primary Completion Date : April 2007
Actual Study Completion Date : April 2007

Primary Outcome Measures :
  1. Change in minimum luminal diameter from baseline assessed by Quantitative Angiography
  2. Coronary Flow Reserve (max/basal CBFV) assessed by coronary Doppler Wire
  3. Correlation between the change in culprit epicardial artery stenosis MLD and atherectomy specimen ET-1 content assessed by immunochemistry

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Adult men and women between the ages of 18 to 75 years will be enrolled and categorized into one of 4 groups. The categories are defined below:

  • Control patients characterized by chest pain and angiographically normal coronary arteries.
  • Chronic stable angina patients who describe a history of exertional chest pain which is unchanged in frequency over the preceding month, and who have at least a 70% stenosis in a coronary artery.
  • Unstable angina patients who describe chest pain at rest or with minimal exertion over the preceding 2 weeks, and who have an identifiable culprit stenosis in a coronary artery.
  • Cardiac transplant recipients who are undergoing routine annual surveillance cardiac catheterization.

Exclusion Criteria:

Patients with the following will be excluded from the study:

  • Angiographic exclusion criteria: *Left main coronary artery disease or severe triple vessel disease; *Unstable angina without any identifiable culprit lesion.
  • Severe left ventricular dysfunction (ejection fraction < 40%) or clinical cardiac failure.
  • Nitroglycerin required in the preceding 4 hours prior to the investigation.
  • Severe renal, hepatic or hematologic abnormalities.
  • Inability to obtain written informed consent.

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): NCT00115583

United States, Massachusetts
Brigham and Womens Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Principal Investigator: Peter A Ganz, MD Brigham and Women's Hospital

Responsible Party: Peter A. Ganz, Brigham & Women's Hospital Identifier: NCT00115583     History of Changes
Other Study ID Numbers: 1999-P-003104
P01HL048743 ( U.S. NIH Grant/Contract )
First Posted: June 24, 2005    Key Record Dates
Last Update Posted: December 9, 2016
Last Verified: December 2016

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