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Extracellular RNAs in Relation to Cardiometabolic Risk

NCT ID: NCT03225196

Last Updated: 2023-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

4495 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-17

Study Completion Date

2020-06-11

Brief Summary

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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

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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.

Conditions

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Subclinical Atherosclerotic Cardiovascular Disease Blood Pressure Obesity

Keywords

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Extracellular RNA MicroRNA Natural History

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniel Levy, M.D.

Role: PRINCIPAL_INVESTIGATOR

National Heart, Lung, and Blood Institute (NHLBI)

Locations

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Framingham Heart Study

Framingham, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 25657313 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26969789 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24242183 (View on PubMed)

Other Identifiers

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17-H-N134

Identifier Type: -

Identifier Source: secondary_id

999917134

Identifier Type: -

Identifier Source: org_study_id