NCT00001461

Brief Summary

The walls of blood vessels are lined by flat cells that are responsible for releasing substance(s) that control the activity of the blood vessel. These cells are referred to as the endothelium of the blood vessel. One of the substances released from the endothelium is called nitric oxide (NO). This substance functions to keep blood vessels relaxed and to prevent blood from clotting inside the vessels. Studies done by researchers in the Cardiology Branch of the National Heart, Lung and Blood Institute have shown that nitric oxide activity may be lower in patients with hardening of the arteries (atherosclerosis) and risk factors for atherosclerosis. Another substance released by the cells of the endothelium is called bradykinin. It functions to stimulate the production of nitric oxide. Therefore bradykinin is also responsible for the relaxation and widening of blood vessels. An enzyme found in the blood called angiotensin-converting enzyme (ACE) inactivates baradykinin and thereby decreases the production of nitric oxide. The activity of ACE is determined by genetics and is different in each person. Medications that block ACE (ACE-inhibitors) may be useful for patients with high levels of ACE activity. This study is designed to determine;

  1. 1.The role of bradkinin in stimulating the production of nitric oxide
  2. 2.Whether ACE-inhibitors improve blood vessel relaxation caused by bradykinin
  3. 3.Whether ACE-inhibitors improve abnormal blood vessel relaxation
  4. 4.Whether ACE-inhibitors and bradykinin affect blood clotting
  5. 5.Whether blood vessel response to ACE-inhibitor and bradykinin depends on the patients genetic make-up

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
209

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 1995

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 1995

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2001

Completed
1.7 years until next milestone

First Posted

Study publicly available on registry

December 10, 2002

Completed
Last Updated

March 4, 2008

Status Verified

April 1, 2000

First QC Date

November 3, 1999

Last Update Submit

March 3, 2008

Conditions

Keywords

Angiotensin Converting EnzymeAngiotensin Converting Enzyme InhibitorsBradykininEndothelial FunctionNitric OxideCoronary Artery Disease

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Anyone with chest pain with known or suspected coronary artery disease.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

National Heart, Lung and Blood Institute (NHLBI)

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

  • Panza JA, Casino PR, Kilcoyne CM, Quyyumi AA. Role of endothelium-derived nitric oxide in the abnormal endothelium-dependent vascular relaxation of patients with essential hypertension. Circulation. 1993 May;87(5):1468-74. doi: 10.1161/01.cir.87.5.1468.

    PMID: 8491001BACKGROUND

MeSH Terms

Conditions

AtherosclerosisCoronary DiseaseCoronary Artery Disease

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesMyocardial IschemiaHeart Diseases

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

November 3, 1999

First Posted

December 10, 2002

Study Start

March 1, 1995

Study Completion

April 1, 2001

Last Updated

March 4, 2008

Record last verified: 2000-04

Locations