NCT00001747

Brief Summary

Black Americans tend to die more often from and have more diseases associated with heart disease than White Americans. The exact cause of this is unknown, but it is likely a combination of genetics, behavior, risk factors, strategies for education and prevention, and socioeconomic factors. Recent studies have suggested that faster biological processes in blood vessels of Black Americans may be the cause of increased amounts of heart disease. In addition, small blood vessels in Black Americans seem to be less responsive to substances that relax blood vessels, which may explain increased blood pressure levels. In this study researchers plan to study artery relaxation (dilation) in response substances affecting the cells lining blood vessels (endothelin). Researchers will compare the results of this study in black and white people to find out whether racial differences may contribute to increases in heart disease and heart related deaths in blacks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
108

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 1998

Typical duration 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

May 1, 1998

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2001

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

December 10, 2002

Completed
Last Updated

March 4, 2008

Status Verified

May 1, 2000

First QC Date

November 3, 1999

Last Update Submit

March 3, 2008

Conditions

Keywords

Brachial ArteryDopplerEndotheliumNitric OxideNitroglycerinNormal Volunteer

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Black and white normal volunteers, approximately matched for age and sex, will be included in the study. All subjects must be capable of rendering informed consent for all procedures. Volunteers with a history or evidence of present or past hypertension (BP greater than 140/90), diabetes mellitus, hypercholesterolemia (plasma cholesterol greater than 200 mg/dL), cardiac disease, peripheral vascular disease, coagulopathy, chronic smoking (2 pack-years or more), obesity (20% greater than ideal body weight), hyperhomocysteinemia (plasma homocysteine greater than 17 umol/1) or any other disease predisposing them to vasculitis will be excluded from the study. No pregnant women. Volunteers who are taking any medication will be excluded.

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 (6)

  • Hutchinson RG, Watson RL, Davis CE, Barnes R, Brown S, Romm F, Spencer JM, Tyroler HA, Wu K. Racial differences in risk factors for atherosclerosis. The ARIC Study. Atherosclerosis Risk in Communities. Angiology. 1997 Apr;48(4):279-90. doi: 10.1177/000331979704800401.

    PMID: 9112876BACKGROUND
  • Geronimus AT, Bound J, Waidmann TA, Hillemeier MM, Burns PB. Excess mortality among blacks and whites in the United States. N Engl J Med. 1996 Nov 21;335(21):1552-8. doi: 10.1056/NEJM199611213352102.

    PMID: 8900087BACKGROUND
  • Fang J, Madhavan S, Alderman MH. The association between birthplace and mortality from cardiovascular causes among black and white residents of New York City. N Engl J Med. 1996 Nov 21;335(21):1545-51. doi: 10.1056/NEJM199611213352101.

    PMID: 8900086BACKGROUND
  • Tsimikas S, Szarek M, Cobbaert CM, Romijn F, Jukema JW, Bhatt DL, Bittner VA, Diaz R, Fazio S, Garon G, Yuan C, Gong XM, Goodman SG, White HD, Witztum JL, Steg PG, Schwartz GG; ODYSSEY OUTCOMES Investigators. Oxidized Phospholipids, Lipoprotein(a), and Cardiovascular Outcomes After Acute Coronary Syndrome. Circulation. 2025 Dec 16;152(24):1666-1678. doi: 10.1161/CIRCULATIONAHA.125.073855. Epub 2025 Dec 1.

  • van Ommen AM, Diez Benavente E, Onland-Moret NC, Valstar GB, Cramer MJ, Rutten FH, Teske AJ, Menken R, Hofstra L, Tulevski II, Sweitzer N, Somsen GA, den Ruijter HM. Plasma Proteomic Patterns Show Sex Differences in Early Concentric Left Ventricular Remodeling. Circ Heart Fail. 2023 Jul;16(7):e010255. doi: 10.1161/CIRCHEARTFAILURE.122.010255. Epub 2023 Jun 29.

  • Maruyama M, Yamamoto T, Abe J, Yodogawa K, Seino Y, Atarashi H, Shimizu W. Number needed to entrain: a new criterion for entrainment mapping in patients with intra-atrial reentrant tachycardia. Circ Arrhythm Electrophysiol. 2014 Jun;7(3):490-6. doi: 10.1161/CIRCEP.113.001416. Epub 2014 Apr 24.

MeSH Terms

Conditions

AtherosclerosisHypertension

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

November 3, 1999

First Posted

December 10, 2002

Study Start

May 1, 1998

Study Completion

March 1, 2001

Last Updated

March 4, 2008

Record last verified: 2000-05

Locations