- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03225196
Extracellular RNAs in Relation to Cardiometabolic Risk
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....
Study Overview
Status
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Massachusetts
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Framingham, Massachusetts, United States, 01702
- Framingham Heart Study
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
- 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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
subclinical Atherosclerotic disease
Time Frame: 7 years
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7 years
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Collaborators and Investigators
Investigators
- Principal Investigator: Daniel Levy, M.D., National Heart, Lung, and Blood Institute (NHLBI)
Publications and helpful links
General 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.
- Tanriverdi 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.
- Yao 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 999917134
- 17-H-N134
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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