The Contribution of Endothelin to Vasomotor Function in Diseased Coronary Arteries
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Brigham and Women's Hospital.
Recruitment status was Active, not recruiting
Information provided by:
Brigham and Women's Hospital
First received: June 23, 2005
Last updated: May 3, 2010
Last verified: May 2010
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.
Drug: Drug Infusion (BQ-123)
Intervention Model: Crossover Assignment
Masking: Open Label
||The Contribution of Endothelin to Vasoreactivity in Atherosclerotic Coronary Arteries
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:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||July 2010 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years to 75 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00115583
|Brigham and Womens Hospital
|Boston, Massachusetts, United States, 02115 |
Brigham and Women's Hospital
||Peter A Ganz, MD
||Brigham and Women's Hospital
No publications provided
||Peter A. Ganz, Brigham & Women's Hospital
History of Changes
|Other Study ID Numbers:
||1999-P-003104, PO1 HL48743
|Study First Received:
||June 23, 2005
||May 3, 2010
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on April 23, 2014
Coronary Artery Disease
Arterial Occlusive Diseases