Biomarkers for Cardiovascular Disease

NCT00109018 | Completed

• 2 other identifiers: 05014505-H-0145
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Artery Disease

Keywords

Risk Assessment; Coronary Heart Disease; Vascular Function; Nitric Oxide Metabolites; Blood Tests; Nitrite; Flow-Mediated Dilation; Biomarker; Endothelial Dysfunction; Coronary Artery Disease; CAD; Coronary Artery Disease At Risk; Healthy Volunteer

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults older than 21, of both sexes:
• The initial study group will consist of 120 subjects, which will consist of 100 subjects with documented CAD (by cardiac catheterization showing greater than or equal to 70% stenosis in an epicardial vessel), previously documented MI (based on ECG or cardiac enzymes) or CAD risk equivalents (diabetes, peripheral vascular disease, abdominal aortic aneurysm, symptomatic carotid disease, or multiple risk factors that confer a 10 year risk of greater than 20% as defined by the Framingham Risk Score) and 20 healthy age- and sex-matched controls.
• Written informed consent.

You may not qualify if:

• Atrial fibrillation
• Any contraindications to oral nitrates
• Hypotension, bradycardia.
• Myocardial infarction within the prior 30 days
• Symptoms of acute CHF
• Pregnant women
• Receiving active treatment for cancer
• Any other condition that may interfere with the interpretation of the study results or not be in the best interest of the subject in the opinion of the investigator.
• Since oral nitrate therapy is known to affect serum and possibly whole blood nitrite levels, we will exclude patients on long-acting nitrates for the initial group of 100 cardiac patients. Those patients on chronic nitrate therapy will subsequently be included in the later portion of the study but will be analyzed separately.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Myerburg RJ, Interian A Jr, Mitrani RM, Kessler KM, Castellanos A. Frequency of sudden cardiac death and profiles of risk. Am J Cardiol. 1997 Sep 11;80(5B):10F-19F. doi: 10.1016/s0002-9149(97)00477-3.

  PMID: 9291445 BACKGROUND

• Wilson PW, D'Agostino RB, Levy D, Belanger AM, Silbershatz H, Kannel WB. Prediction of coronary heart disease using risk factor categories. Circulation. 1998 May 12;97(18):1837-47. doi: 10.1161/01.cir.97.18.1837.

  PMID: 9603539 BACKGROUND

• Ridker PM, Rifai N, Rose L, Buring JE, Cook NR. Comparison of C-reactive protein and low-density lipoprotein cholesterol levels in the prediction of first cardiovascular events. N Engl J Med. 2002 Nov 14;347(20):1557-65. doi: 10.1056/NEJMoa021993.

  PMID: 12432042 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Disease

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: April 21, 2005
• First Posted: April 22, 2005
• Study Start: April 19, 2005
• Study Completion: April 15, 2009
• Last Updated: July 2, 2017

Record last verified: 2009-04-15

Locations

US (1)