NCT03225196

Brief 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. 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....

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,495

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 17, 2017

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

July 20, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 21, 2017

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 11, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 11, 2020

Completed
Last Updated

December 15, 2023

Status Verified

December 1, 2023

Enrollment Period

2.9 years

First QC Date

July 20, 2017

Last Update Submit

December 14, 2023

Conditions

Keywords

Extracellular RNAMicroRNANatural History

Outcome Measures

Primary Outcomes (1)

  • subclinical Atherosclerotic disease

    7 years

Study Arms (1)

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

Eligibility Criteria

Age21 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Framingham Heart Study

Framingham, Massachusetts, 01702, United States

Location

Related Publications (3)

  • 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.

    PMID: 25657313BACKGROUND
  • 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.

    PMID: 26969789BACKGROUND
  • 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.

    PMID: 24242183BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Daniel Levy, M.D.

    National Heart, Lung, and Blood Institute (NHLBI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2017

First Posted

July 21, 2017

Study Start

July 17, 2017

Primary Completion

June 11, 2020

Study Completion

June 11, 2020

Last Updated

December 15, 2023

Record last verified: 2023-12

Locations