The Contribution of Endothelin to Vasomotor Function in Diseased Coronary Arteries

NCT00115583 | Completed

• 2 other identifiers: 1999-P-003104P01HL048743
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Atherosclerosis, Coronary

Outcome Measures

Primary Outcomes (3)

• 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

Interventions

Drug Infusion (BQ-123) DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients with the following will be excluded from the study:
• 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.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Womens Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

cyclo(Trp-Asp-Pro-Val-Leu)

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Peter A Ganz, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 23, 2005
• First Posted: June 24, 2005
• Study Start: November 1, 1998
• Primary Completion: April 1, 2007
• Study Completion: April 1, 2007
• Last Updated: December 9, 2016

Record last verified: 2016-12

Locations

US (1)