AtherosclerosisNCT00001747
Racial Differences in Control of Blood Vessel Tone and Blood Flow
An observational study of Atherosclerosis and Healthy, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atherosclerosis, Healthy, Hypertension
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- May 1998to Mar 2001
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Heart, Lung and Blood Institute (NHLBI)
Bethesda, Maryland, 20892
About this study
Official title: Racial Differences in Flow Mediated Vasodilator Function
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.
Read the detailed description
Black Americans have a greater morbidity and mortality related to cardiovascular diseases compared to whites. The cause for this phenomenon is probably multifactorial and includes differences in pathogenesis, risk factor patterns, genetic background, behavioral variables, strategies for education and prevention, and socioeconomic factors. Recent evidence suggests that acceleration of some of the processes related to vascular biology may account for the greater prevalence of cardiovascular disease in blacks. A diminished vasodilator response of the microvasculature has been shown in African Americans and may therefore be responsible for their increased prevalence of hypertension. Endothelial dysfunction is a central mechanism in the development of atherosclerosis. It is therefore reasonable to postulate that endothelial dysfunction of large conductance arteries may also contribute to a greater susceptibility to atherosclerosis in blacks compared to whites, even in those individuals without the known risk factors for coronary heart disease. In the present study, we propose to investigate brachial artery dilation in response to endothelium-dependent and -independent stimuli in black and white individuals to determine whether racial differences in the vascular biology of large conductance vessels that might contribute to the greater cardiovascular morbidity and mortality previously reported in blacks.
- Conditions
- Atherosclerosis, Healthy, Hypertension
- Keywords
- Brachial Artery, Doppler, Endothelium, Nitric Oxide, Nitroglycerin, Normal Volunteer
- Medical subject headings
- Atherosclerosis, Hypertension
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2002 (estimated)
- Study startMay 1998
- Study completionMar 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 108 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001747
- Sponsor's protocol ID
- 980112
- Other IDs
- 98-H-0112
- Status last verified
- May 2000
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
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.
PubMed 9112876Geronimus 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.
PubMed 8900087Fang 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.
PubMed 8900086Tsimikas 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.
PubMed 41321238van 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.
PubMed 37381923Maruyama 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.
PubMed 24762806
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Racial Differences in Flow Mediated Vasodilator Function
- ClinicalTrials.gov ID
- NCT00001747
- Acronym / sponsor ID
- 980112
- Conditions
- Atherosclerosis, Healthy, Hypertension
- Keywords
- Brachial Artery, Doppler, Endothelium, Nitric Oxide, Nitroglycerin, Normal Volunteer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- May 1998
- Study completion
- Mar 2001
- First posted
- 10 Dec 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Black Americans have a greater morbidity and mortality related to cardiovascular diseases compared to whites. The cause for this phenomenon is probably multifactorial and includes differences in pathogenesis, risk factor patterns, genetic background, behavioral variables, strategies for education and prevention, and socioeconomic factors. Recent evidence suggests that acceleration of some of the processes related to vascular biology may account for the greater prevalence of cardiovascular disease in blacks. A diminished vasodilator response of the microvasculature has been shown in African Americans and may therefore be responsible for their increased prevalence of hypertension. Endothelial dysfunction is a central mechanism in the development of atherosclerosis. It is therefore reasonable to postulate that endothelial dysfunction of large conductance arteries may also contribute to a greater susceptibility to atherosclerosis in blacks compared to whites, even in those individuals without the known risk factors for coronary heart disease. In the present study, we propose to investigate brachial artery dilation in response to endothelium-dependent and -independent stimuli in black and white individuals to determine whether racial differences in the vascular biology of large conductance vessels that might contribute to the greater cardiovascular morbidity and mortality previously reported in blacks.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 9112876Hutchinson 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.
- Background: PubMed 8900087Geronimus 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.
- Background: PubMed 8900086Fang 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.
- Derived from this study: PubMed 41321238Tsimikas 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.
- Derived from this study: PubMed 37381923van 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.
- Derived from this study: PubMed 24762806Maruyama 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.
Related trials for Atherosclerosis
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Active, not recruiting
SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
Peripheral Artery Disease
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingPhase 3
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
Peripheral Artery Disease (PAD)
Recruiting
The THOR IDE Study
Peripheral Artery Disease, Peripheral Artery Stenosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atherosclerosis and Healthy, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001747, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008.