Carotid Artery PlaqueNCT03416257
TMAO and Atherosclerosis in HIV
An observational study of Carotid Artery Plaque, run by Albert Einstein College of Medicine.
Trial summary
In the present study, the investigators sought to prospectively examine the associations of plasma levels of TMAO (trimethylamine oxide), choline, betaine, dimethylglycine, and sarcosine with risk of incident carotid artery plaque, assessed by repeated B-mode carotid artery ultrasound imaging over a 7-year period, in… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Carotid Artery Plaque
- How many people
- 737 participants
- Where
- No sites listed yet
- Study dates
- 12 Apr 2004to 4 Apr 2017
- 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
Study population: A total of 737 women and men with available baseline plasma choline metabolite data were included in this analysis. There were 520 HIV-infected (291 women, 229 men) and 217 HIV-uninfected (107 women, 110 men) participants included in this study. Baseline characteristics are shownin Table 1. HIV-infected and HIV-uninfected participants were generally similar in terms of demographic and behavioral variables, although HIV-infected participants were more likely to have a history of HCV infection. In addition, HIV-infected participants had lower total cholesterol and HDL cholesterol levels compared to those without HIV infection. The majority of HIV-infected individuals reported using potent ART at baseline (74% in women and 83% in men), and 46% of women and 66% of men had undetectable HIV-1 viral load (≤80 copies/mL). Compared to men, women were younger, more likely to be of black race or Hispanice thnicity and current smokers, and have a history of HCV infection and higher BMI.
Who may be able to join
- participants who underwent carotid artery imaging for plaque assessment at a baseline visit (2004-2006) and at a follow-up visit (2011-2013).
Who cannot join
- a history of coronary heart disease, individuals with prevalent diabetes or prevalent carotid artery plaques at baseline
About this study
Official title: Gut Microbial-related Choline Metabolite Trimethylamine-N-oxide is Associated With Progression of Carotid Artery Atherosclerosis in HIV Infection
In the present study, the investigators sought to prospectively examine the associations of plasma levels of TMAO (trimethylamine oxide), choline, betaine, dimethylglycine, and sarcosine with risk of incident carotid artery plaque, assessed by repeated B-mode carotid artery ultrasound imaging over a 7-year period, in women and men with and without HIV infection from the WIHS (Women Interagency HIV Study) and MACS (Multicenter Aids Cohort Study).
- Conditions
- Carotid Artery Plaque
- Being tested
- No intervention
- Medical subject headings
- Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
| Study group | Role | What they receive |
|---|---|---|
| WIHS | Women's Interagency HIV Study Receives: Other: No intervention | |
| MACS | Multicenter AIDS Cohort Study Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
incident carotid artery plaque
assessed by repeated B-mode carotid artery ultrasound imaging
Measured: 2011-2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2018
- Study start12 Apr 2004
- Primary completion1 Sep 2013
- Study completion4 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid Artery PlaqueStudies of the same condition, open and under way.
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 737 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Qibin Qi, Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03416257
- Sponsor's protocol ID
- 2015-5145
- Other IDs
- K01HL129892
- Status last verified
- Jun 2018
- First submitted
- 24 Jan 2018
- Last updated
- 14 Jun 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gut Microbial-related Choline Metabolite Trimethylamine-N-oxide is Associated With Progression of Carotid Artery Atherosclerosis in HIV Infection
- ClinicalTrials.gov ID
- NCT03416257
- Acronym / sponsor ID
- 2015-5145
- Conditions
- Carotid Artery Plaque
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 737 participants (actual)
- Lead sponsor
- Albert Einstein College of MedicineUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 12 Apr 2004 (actual)
- Primary completion
- 1 Sep 2013 (actual)
- Study completion
- 4 Apr 2017 (actual)
- First posted
- 31 Jan 2018 (actual)
- 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.
In the present study, the investigators sought to prospectively examine the associations of plasma levels of TMAO (trimethylamine oxide), choline, betaine, dimethylglycine, and sarcosine with risk of incident carotid artery plaque, assessed by repeated B-mode carotid artery ultrasound imaging over a 7-year period, in women and men with and without HIV infection from the WIHS (Women Interagency HIV Study) and MACS (Multicenter Aids Cohort Study).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WIHS | – | Other: No interventionWomen's Interagency HIV Study |
| MACS | – | Other: No interventionMulticenter AIDS Cohort Study |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A total of 737 women and men with available baseline plasma choline metabolite data were included in this analysis. There were 520 HIV-infected (291 women, 229 men) and 217 HIV-uninfected (107 women, 110 men) participants included in this study. Baseline characteristics are shownin Table 1. HIV-infected and HIV-uninfected participants were generally similar in terms of demographic and behavioral variables, although HIV-infected participants were more likely to have a history of HCV infection. In addition, HIV-infected participants had lower total cholesterol and HDL cholesterol levels compared to those without HIV infection. The majority of HIV-infected individuals reported using potent ART at baseline (74% in women and 83% in men), and 46% of women and 66% of men had undetectable HIV-1 viral load (≤80 copies/mL). Compared to men, women were younger, more likely to be of black race or Hispanice thnicity and current smokers, and have a history of HCV infection and higher BMI.
Key inclusion criteria (1 listed)
- participants who underwent carotid artery imaging for plaque assessment at a baseline visit (2004-2006) and at a follow-up visit (2011-2013).
Key exclusion criteria (1 listed)
- a history of coronary heart disease, individuals with prevalent diabetes or prevalent carotid artery plaques at baseline
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention | Other | MACS, WIHS |
Primary outcome
incident carotid artery plaque
Time frame: 2011-2013
assessed by repeated B-mode carotid artery ultrasound imaging
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 14 Jun 2018.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Carotid Artery Plaque, run by Albert Einstein College of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. 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 14 Jun 2018. 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.
What does the primary outcome measure?
incident carotid artery plaque (time frame: 2011-2013). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jun 2018.