Subclinical Atherosclerotic Cardiovascular DiseaseNCT03225196
Extracellular RNAs in Relation to Cardiometabolic Risk
An observational study of Subclinical Atherosclerotic Cardiovascular Disease and Blood Pressure, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial summary
Background: Extracellular RNAs (exRNAs) send genetic data from cell to cell. This is how they affect the way cells communicate with each other. There are many types of exRNA, and they each serve different roles. But they have also been linked to some diseases. Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Subclinical Atherosclerotic Cardiovascular Disease, Blood Pressure, Obesity
- How many people
- 4,495 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jul 2017to 11 Jun 2020
- 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 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We seek to measure a 665 exRNAs spanning a variety of classes in plasma from 4095 young to middle-aged adult participants in the Third Generation cohort of the FHS
- ELIGIBILITY CRITERIA:
- FHS Third Generation cohort participants with WGS as part of TOPMed.
- FHS Third Generation cohort participants who attended exam 2 when PaxGene tubes were collected for RNA isolation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Framingham Heart Study
Framingham, Massachusetts, 01702
About this study
Background:
Extracellular RNAs (exRNAs) send genetic data from cell to cell. This is how they affect the way cells communicate with each other. There are many types of exRNA, and they each serve different roles. But they have also been linked to some diseases. Researchers want to measure exRNAs to see how they relate to certain traits over time. They will use blood samples that were taken as part of the Framingham Heart Study (FHS).
Read more
Objectives:
To identify cross-sectional associations of exRNAs with age, sex, and cardiometabolic risk factors.
Eligibility:
People ages 30-70 who had blood taken as part of the FHS Third Generation cohort.
Design:
Researchers will study samples that have already been collected in the FHS. There will be no active participant contact for this project, only use of data that are collected as part of planned follow up from other studies.
As part of the FHS, participants gave blood samples. They gave permission for the blood to be used for research.
The exRNAs from the blood samples will be studied to see how they relate to certain traits. These include age, sex, and body mass index.
The exRNAs will also be studied for their usefulness as biomarkers of risk for subclinical atherosclerotic cardiovascular disease.
No study participants will be contacted for this study....
Read the detailed description
Extracellular RNAs (exRNAs) impact a wide range of biological processes and function to transfer genetic information between cells. In doing so, exRNAs affect cell-to-cell communications. Recent studies indicate that exRNAs are associated with a variety of diseases. Emerging data from elderly participants in the Framingham Heart Study (FHS) demonstrate that circulating levels of exRNA are correlated with several key traits including age, sex, and body mass index. Much more work is needed to determine the extent to which exRNAs are associated with a variety of clinically relevant traits across the age spectrum. We seek to measure a 665 exRNAs spanning a variety of classes in plasma from 4095 young to middle-aged adult participants in the Third Generation cohort of the FHS and to relate them to age, sex, and cardiometabolic risk factors (BMI, lipids, blood pressure, and fasting glucose) in cross-sectional analyses and to determine the relations of these exRNAs measured at baseline to serial changes in cardiometabolic risk factors during seven years of follow up. We also seek to relate exRNAs to subclinical atherosclerotic cardiovascular disease (ASCVD; assessed via multidetector CT measures of coronary artery calcium), and its progression during seven years of follow up. This grant application will establish an association of exRNAs with clinically relevant traits and diseases and will establish their utility as biomarkers of risk for cardiometabolic disease and subclinical ASCVD. To this end, we propose three aims: 1) To identify associations of exRNAs with age, sex, and cardiometabolic risk factors and subclinical ASCVD at a baseline examination, 2) To identify associations of exRNAs with longitudinal changes in cardiometabolic risk factors and subclinical ASCVD during seven years of follow up, and 3) To explore the genetic regulation of exRNAs via analysis of whole genome sequence data. We demonstrate that we have adequate power to detect associations of exRNAs with cardiometabolic risk factors and subclinical atherosclerosis at baseline and with their longitudinal change during follow up.
- Keywords
- Extracellular RNA, MicroRNA, Natural History
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Samples | We seek to measure a 665 exRNAs spanning a variety of classes in plasma from 4095 young to middle-aged adult participants in the Third Generation cohort of the FHS |
What is being measured
The primary outcome is the main question the study is designed to answer.
subclinical Atherosclerotic disease
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start17 Jul 2017
- Primary completion11 Jun 2020
- Study completion11 Jun 2020
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 Subclinical Atherosclerotic Cardiovascular DiseaseStudies 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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 4,495 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Daniel Levy, M.D., Principal investigator, National Heart, Lung, and Blood Institute (NHLBI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03225196
- Sponsor's protocol ID
- 999917134
- Other IDs
- 17-H-N134
- Status last verified
- Dec 2023
- First submitted
- 20 Jul 2017
- Last updated
- 15 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Huan T, Rong J, Tanriverdi K, Meng Q, Bhattacharya A, McManus DD, Joehanes R, Assimes TL, McPherson R, Samani NJ, Erdmann J, Schunkert H, Courchesne P, Munson PJ, Johnson AD, O'Donnell CJ, Zhang B, Larson MG, Freedman JE, Levy D, Yang X. Dissecting the roles of microRNAs in coronary heart disease via integrative genomic analyses. Arterioscler Thromb Vasc Biol. 2015 Apr;35(4):1011-21. doi: 10.1161/ATVBAHA.114.305176. Epub 2015 Feb 5.
PubMed 25657313Tanriverdi K, Kucukural A, Mikhalev E, Tanriverdi SE, Lee R, Ambros VR, Freedman JE. Comparison of RNA isolation and associated methods for extracellular RNA detection by high-throughput quantitative polymerase chain reaction. Anal Biochem. 2016 May 15;501:66-74. doi: 10.1016/j.ab.2016.02.019. Epub 2016 Mar 10.
PubMed 26969789Yao C, Joehanes R, Johnson AD, Huan T, Esko T, Ying S, Freedman JE, Murabito J, Lunetta KL, Metspalu A, Munson PJ, Levy D. Sex- and age-interacting eQTLs in human complex diseases. Hum Mol Genet. 2014 Apr 1;23(7):1947-56. doi: 10.1093/hmg/ddt582. Epub 2013 Nov 15.
PubMed 24242183
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extracellular RNAs in Relation to Cardiometabolic Risk
- ClinicalTrials.gov ID
- NCT03225196
- Acronym / sponsor ID
- 999917134
- Keywords
- Extracellular RNA, MicroRNA, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,495 participants (actual)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- 17 Jul 2017 (actual)
- Primary completion
- 11 Jun 2020 (actual)
- Study completion
- 11 Jun 2020 (actual)
- First posted
- 21 Jul 2017 (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.
Background:
Extracellular RNAs (exRNAs) send genetic data from cell to cell. This is how they affect the way cells communicate with each other. There are many types of exRNA, and they each serve different roles. But they have also been linked to some diseases. Researchers want to measure exRNAs to see how they relate to certain traits over time. They will use blood samples that were taken as part of the Framingham Heart Study (FHS).
Objectives:
To identify cross-sectional associations of exRNAs with age, sex, and cardiometabolic risk factors.
Eligibility:
People ages 30-70 who had blood taken as part of the FHS Third Generation cohort.
Design:
Researchers will study samples that have already been collected in the FHS. There will be no active participant contact for this project, only use of data that are collected as part of planned follow up from other studies.
As part of the FHS, participants gave blood samples. They gave permission for the blood to be used for research.
The exRNAs from the blood samples will be studied to see how they relate to certain traits. These include age, sex, and body mass index.
The exRNAs will also be studied for their usefulness as biomarkers of risk for subclinical atherosclerotic cardiovascular disease.
No study participants will be contacted for this study....
Detailed description
Extracellular RNAs (exRNAs) impact a wide range of biological processes and function to transfer genetic information between cells. In doing so, exRNAs affect cell-to-cell communications. Recent studies indicate that exRNAs are associated with a variety of diseases. Emerging data from elderly participants in the Framingham Heart Study (FHS) demonstrate that circulating levels of exRNA are correlated with several key traits including age, sex, and body mass index. Much more work is needed to determine the extent to which exRNAs are associated with a variety of clinically relevant traits across the age spectrum. We seek to measure a 665 exRNAs spanning a variety of classes in plasma from 4095 young to middle-aged adult participants in the Third Generation cohort of the FHS and to relate them to age, sex, and cardiometabolic risk factors (BMI, lipids, blood pressure, and fasting glucose) in cross-sectional analyses and to determine the relations of these exRNAs measured at baseline to serial changes in cardiometabolic risk factors during seven years of follow up. We also seek to relate exRNAs to subclinical atherosclerotic cardiovascular disease (ASCVD; assessed via multidetector CT measures of coronary artery calcium), and its progression during seven years of follow up. This grant application will establish an association of exRNAs with clinically relevant traits and diseases and will establish their utility as biomarkers of risk for cardiometabolic disease and subclinical ASCVD. To this end, we propose three aims: 1) To identify associations of exRNAs with age, sex, and cardiometabolic risk factors and subclinical ASCVD at a baseline examination, 2) To identify associations of exRNAs with longitudinal changes in cardiometabolic risk factors and subclinical ASCVD during seven years of follow up, and 3) To explore the genetic regulation of exRNAs via analysis of whole genome sequence data. We demonstrate that we have adequate power to detect associations of exRNAs with cardiometabolic risk factors and subclinical atherosclerosis at baseline and with their longitudinal change during follow up.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Samples | – | –We seek to measure a 665 exRNAs spanning a variety of classes in plasma from 4095 young to middle-aged adult participants in the Third Generation cohort of the FHS |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We seek to measure a 665 exRNAs spanning a variety of classes in plasma from 4095 young to middle-aged adult participants in the Third Generation cohort of the FHS
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
subclinical Atherosclerotic disease
Time frame: 7 years
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 15 Dec 2023.
- Background: PubMed 25657313Huan T, Rong J, Tanriverdi K, Meng Q, Bhattacharya A, McManus DD, Joehanes R, Assimes TL, McPherson R, Samani NJ, Erdmann J, Schunkert H, Courchesne P, Munson PJ, Johnson AD, O'Donnell CJ, Zhang B, Larson MG, Freedman JE, Levy D, Yang X. Dissecting the roles of microRNAs in coronary heart disease via integrative genomic analyses. Arterioscler Thromb Vasc Biol. 2015 Apr;35(4):1011-21. doi: 10.1161/ATVBAHA.114.305176. Epub 2015 Feb 5.
- Background: PubMed 26969789Tanriverdi K, Kucukural A, Mikhalev E, Tanriverdi SE, Lee R, Ambros VR, Freedman JE. Comparison of RNA isolation and associated methods for extracellular RNA detection by high-throughput quantitative polymerase chain reaction. Anal Biochem. 2016 May 15;501:66-74. doi: 10.1016/j.ab.2016.02.019. Epub 2016 Mar 10.
- Background: PubMed 24242183Yao C, Joehanes R, Johnson AD, Huan T, Esko T, Ying S, Freedman JE, Murabito J, Lunetta KL, Metspalu A, Munson PJ, Levy D. Sex- and age-interacting eQTLs in human complex diseases. Hum Mol Genet. 2014 Apr 1;23(7):1947-56. doi: 10.1093/hmg/ddt582. Epub 2013 Nov 15.
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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.
Daniel Levy, M.D. principal investigator
National Heart, Lung, and Blood Institute (NHLBI)
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 Subclinical Atherosclerotic Cardiovascular Disease and Blood Pressure, 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.
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 15 Dec 2023. 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.
What does the primary outcome measure?
subclinical Atherosclerotic disease (time frame: 7 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03225196, 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 15 Dec 2023.