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
Sponsor:
Information provided by:
Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00115583
First received: June 23, 2005
Last updated: May 3, 2010
Last verified: May 2010
  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: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: The Contribution of Endothelin to Vasoreactivity in Atherosclerotic Coronary Arteries

Resource links provided by NLM:


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 2010
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
  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
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: 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

Responsible Party: Peter A. Ganz, Brigham & Women's Hospital
ClinicalTrials.gov Identifier: NCT00115583     History of Changes
Other Study ID Numbers: 1999-P-003104, PO1 HL48743
Study First Received: June 23, 2005
Last Updated: May 3, 2010
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 28, 2014