The Contribution of Endothelin to Vasomotor Function in Diseased Coronary Arteries

This study is ongoing, but not recruiting participants.

First Received: June 23, 2005 Last Updated: May 21, 2007 History of Changes

Sponsor:	Brigham and Women's Hospital
Information provided by:	Brigham and Women's Hospital
ClinicalTrials.gov Identifier:	NCT00115583

Purpose

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	Intervention
Atherosclerosis, Coronary	Drug: Drug Infusion (BQ-123)

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Active Control, Crossover Assignment
Official Title:	The Contribution of Endothelin to Vasoreactivity in Atherosclerotic Coronary Arteries

Resource links provided by NLM:

Drug Information available for: BQ 123

U.S. FDA Resources

Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:

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

Estimated Enrollment:	200
Study Start Date:	November 1998
Estimated Study Completion Date:	July 2005

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00115583

Locations

United States, Massachusetts
Brigham and Womens Hospital
Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Brigham and Women's Hospital

Investigators

Principal Investigator:

Peter A Ganz, MD

Brigham and Women's Hospital

More Information

No publications provided

Study ID Numbers:	1999-P-003104, PO1 HL48743
Study First Received:	June 23, 2005
Last Updated:	May 21, 2007
ClinicalTrials.gov Identifier:	NCT00115583 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Coronary Disease
Arterial Occlusive Diseases
Atherosclerosis
Heart Diseases
Myocardial Ischemia

Vascular Diseases
Cardiovascular Diseases
Arteriosclerosis
Coronary Artery Disease

ClinicalTrials.gov processed this record on November 27, 2009