NCT00109018

Biomarkers for Cardiovascular Disease

Completed Last updated 2 July 2017

What this trial tests

trial in Coronary Artery Disease in 120 participants. Completed in 15 April 2009.

Timeline

19 April 2005

15 April 2009

Quick facts

Lead sponsor	National Heart, Lung, and Blood Institute (NHLBI)
Status	Completed
Study type	OBSERVATIONAL
Enrollment	120
Start date	19 April 2005
Estimated completion	15 April 2009
Sites	1 location across United States

Conditions studied

• Coronary Artery Disease — all drugs for Coronary Artery Disease →

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Who can join

21 and older, any sex, with Coronary Artery Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Biomarkers for Cardiovascular Disease

Summary: This study will examine the function of the lining cells of blood vessels and measure substances in the blood to see how they relate to various blood tests, including new tests under development to determine cardiovascular disease risk. Nitric oxide is a molecule produced by healthy blood vessels that helps keep them relaxed. Nitrate is a substance formed from nitric oxide in the blood. The release of nitric oxide by blood vessels is reduced in patients with coronary artery disease, compared with healthy people. Also, blood nitrite levels rise in some of these patients. Other substances in the blood and urine also change with risk for heart disease. This study will measure nitrite levels and other inflammatory substances in the blood and urine.

Healthy volunteers, people with various risk factors for heart disease, and people with blockage of one or more major heart arteries or a history of heart attack may be eligible for this study. Candidates must be 21 years of age or older. People who have an irregular heart rhythm or who cannot take oral nitrates are excluded.

Participants undergo the following tests and procedures:

* Blood tests: Samples are drawn three times for routine tests and to look for certain proteins that may affect the heart. Samples are collected once before any other tests, once before starting the exercise stress test (see below) and again after the stress test.
* Urine test: A sample may be tested for proteins in the urine and for other research studies.
* Brachial artery reactivity study: This ultrasound study tests how well a person's arteries widen. The subject rests on a bed. An ultrasound measuring device is placed over the artery just above the elbow. The size of the artery and blood flow through it are measured before and after inflating a pressure cuff around the forearm. The pressure cuff stops the flow of blood to the arm for 5 minutes and then is released while more ultrasound pictures are taken. After the subject rests, a nitroglycerin tablet (medicine that causes blood vessels to relax) is placed under the tongue. After the nitroglycerin is given, the size of the artery and blood flow through it are measured again. After a rest period, the study will be repeated in the healthy volunteers and first 20 patients with heart disease.
* Echocardiography (heart ultrasound): This test involves holding a small probe against the chest to use sound waves for obtaining pictures of the heart. A small catheter (plastic tube) may be placed in a vein to inject a contrast agent that enhances the pictures.
* Metabolic stress testing: Subjects will be asked to breathe in and out of a mask while baseline measurements are taken. Then they exercise on a treadmill while wearing a breathing mask. This test shows how much oxygen the body uses at rest and with exercise.
* Genetic testing (optional): A blood sample is collected to examine DNA - genetic material that determines inherited traits and contains information about body proteins. Some parts of DNA may be used as markers of the level of damage produced by oxygen by-products that may reflect the extent of heart disease in patients. Also, gene variations may make an individual more likely to develop a heart problem. Such markers may guide doctors in predicting how fast the disease will progress or may help find a new type of drug to prevent disease.
* Time requirements: This study is expected to take approximately 5-6 hours for completion within one or two days.
* Follow-up: Patients are contacted by phone every 6 months for information on chest pain, surgical procedures related to the heart, and hospitalizations.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.