Cardiovascular DiseasesNCT00005506
Vascular Disease--Structure/Function
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To investigate the relationship of non-invasively measured flow-mediated brachial artery dilation with coronary artery disease (CAD). Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Coronary Disease
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jan 1998to Jun 2000
- 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 Up to 100 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
To investigate the relationship of non-invasively measured flow-mediated brachial artery dilation with coronary artery disease (CAD).
Read the detailed description
BACKGROUND:
This study meshed with a longitudinal case-control study, HL-35333, Carotid Atherosclerosis Follow-Up Study. HL-35333 comprised 280 individuals older than 45 equally divided between men and women, half with and half without CAD evaluated for risk factors at baseline and with completed follow-up with yearly B-mode for three years. The Carotid Atherosclerosis Follow-Up Study quantified the interassociations of angiographically defined coronary artery disease and CAD risk factors with progression. The NIH funded a continuation of this effort to review existing ultrasound tapes from this study in order to additionally evaluate the associations of all these factors with extracranial carotid arterial dimensions (ECAD: interadventitial and lumen diameters) and change in ECAD over time.
DESIGN NARRATIVE:
The study assessed brachial artery reactivity among 100 CAD subjects and 100 controls who had been previously enrolled in a study of the relationship between extracranial intima media thickness (ECIMT) as assessed by B mode ultrasonographic measurements and CAD status. Most subjects had three consecutive B mode measurements at 12 month intervals. These subjects had brachial artery reactivity measurements according to a standardized protocol. Linear regression analysis was used to relate brachial artery reactivity to CAD status, gender and risk factors as predictors. Interaction effects were also assessed between CAD status and other risk factors and also between gender and other risk factors. Similar analyses were performed to relate percent dilation to ECIMT measurements.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
- Conditions
- Cardiovascular Diseases, Heart Diseases, Coronary Disease
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Coronary Disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startJan 1998
- Study completionJun 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies 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
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- John Crouse, III, Wake Forest University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005506
- Sponsor's protocol ID
- 5024
- Other IDs
- R01HL059503
- Status last verified
- Apr 2004
- First submitted
- 25 May 2000
- Last updated
- 16 Mar 2016
- Results posted
- No
Publications
Espeland MA, Tang R, Terry JG, Davis DH, Mercuri M, Crouse JR 3rd. Associations of risk factors with segment-specific intimal-medial thickness of the extracranial carotid artery. Stroke. 1999 May;30(5):1047-55. doi: 10.1161/01.str.30.5.1047.
PubMed 10229743Herrington DM, Fan L, Drum M, Riley WA, Pusser BE, Crouse JR, Burke GL, McBurnie MA, Morgan TM, Espeland MA. Brachial flow-mediated vasodilator responses in population-based research: methods, reproducibility and effects of age, gender and baseline diameter. J Cardiovasc Risk. 2001 Oct;8(5):319-28. doi: 10.1177/174182670100800512.
PubMed 11702039Terry JG, Tang R, Espeland MA, Davis DH, Vieira JL, Mercuri MF, Crouse JR 3rd. Carotid arterial structure in patients with documented coronary artery disease and disease-free control subjects. Circulation. 2003 Mar 4;107(8):1146-51. doi: 10.1161/01.cir.0000051461.92839.f7.
PubMed 12615793
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular Disease--Structure/Function
- ClinicalTrials.gov ID
- NCT00005506
- Acronym / sponsor ID
- 5024
- Conditions
- Cardiovascular Diseases, Heart Diseases, Coronary Disease
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Jan 1998
- Study completion
- Jun 2000 (actual)
- First posted
- 26 May 2000 (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.
To investigate the relationship of non-invasively measured flow-mediated brachial artery dilation with coronary artery disease (CAD).
Detailed description
BACKGROUND:
This study meshed with a longitudinal case-control study, HL-35333, Carotid Atherosclerosis Follow-Up Study. HL-35333 comprised 280 individuals older than 45 equally divided between men and women, half with and half without CAD evaluated for risk factors at baseline and with completed follow-up with yearly B-mode for three years. The Carotid Atherosclerosis Follow-Up Study quantified the interassociations of angiographically defined coronary artery disease and CAD risk factors with progression. The NIH funded a continuation of this effort to review existing ultrasound tapes from this study in order to additionally evaluate the associations of all these factors with extracranial carotid arterial dimensions (ECAD: interadventitial and lumen diameters) and change in ECAD over time.
DESIGN NARRATIVE:
The study assessed brachial artery reactivity among 100 CAD subjects and 100 controls who had been previously enrolled in a study of the relationship between extracranial intima media thickness (ECIMT) as assessed by B mode ultrasonographic measurements and CAD status. Most subjects had three consecutive B mode measurements at 12 month intervals. These subjects had brachial artery reactivity measurements according to a standardized protocol. Linear regression analysis was used to relate brachial artery reactivity to CAD status, gender and risk factors as predictors. Interaction effects were also assessed between CAD status and other risk factors and also between gender and other risk factors. Similar analyses were performed to relate percent dilation to ECIMT measurements.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
Study design
Who may qualify
- Ages
- Up to 100 years
- Sex
- Male only
- 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 16 Mar 2016.
- Background: PubMed 10229743Espeland MA, Tang R, Terry JG, Davis DH, Mercuri M, Crouse JR 3rd. Associations of risk factors with segment-specific intimal-medial thickness of the extracranial carotid artery. Stroke. 1999 May;30(5):1047-55. doi: 10.1161/01.str.30.5.1047.
- Background: PubMed 11702039Herrington DM, Fan L, Drum M, Riley WA, Pusser BE, Crouse JR, Burke GL, McBurnie MA, Morgan TM, Espeland MA. Brachial flow-mediated vasodilator responses in population-based research: methods, reproducibility and effects of age, gender and baseline diameter. J Cardiovasc Risk. 2001 Oct;8(5):319-28. doi: 10.1177/174182670100800512.
- Background: PubMed 12615793Terry JG, Tang R, Espeland MA, Davis DH, Vieira JL, Mercuri MF, Crouse JR 3rd. Carotid arterial structure in patients with documented coronary artery disease and disease-free control subjects. Circulation. 2003 Mar 4;107(8):1146-51. doi: 10.1161/01.cir.0000051461.92839.f7.
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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.
John Crouse, III
Wake Forest University
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
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 NCT00005506, which also lists 3 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 16 Mar 2016.