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RNA Sequencing in the Framingham Heart Study Third Generation Cohort Exam 2

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ClinicalTrials.gov Identifier: NCT03225183
Recruitment Status : Enrolling by invitation
First Posted : July 21, 2017
Last Update Posted : March 22, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )

Brief Summary:

Background:

The Framingham Heart Study (FHS) was initiated by the U.S Public Health Service in 1948 and turned over to the newly established National Heart Institute in 1951. The FHS is now jointly led by the National Heart, Lung, and Blood Institute and Boston University. The FHS currently studies risk factors, and the genetics of heart and blood vessel disease, and other health conditions in three generations of study participants. Scientists want to use the data collected from this study to do more research. They want to use a technique that determines the sequence of ribonucleic acid (RNA) molecules.

Objective:

To study genes related to certain diseases and health conditions. These include heart and blood vessel diseases, lung and blood diseases, stroke, memory loss, and cancer.

Eligibility:

People in the FHS Third Generation cohort who already attended exam 2.

Design:

Researchers will study samples that have already been collected in the FHS. There will be no active examination or burden to participants. During FHS visits, participants gave blood samples. They gave permission for the blood to be used for genetic research. RNA will be generated from the samples. They will be given a new ID separate from any personal data. They will be stored in a secure FHS lab. The samples will be analyzed. Only certified researchers can access them.

No study participants will be contacted in relation to this project.


Condition or disease
Cardiovascular Disease Hypertension

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 1700 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: An RNA Sequencing Study in the Framingham Heart Study Third Generation Cohort Exam 2
Estimated Study Start Date : March 27, 2019
Estimated Primary Completion Date : March 15, 2020
Estimated Study Completion Date : March 15, 2020

Resource links provided by the National Library of Medicine


Group/Cohort
Cohort Exam 2 Participants
We propose to extend the investigation of transcriptomics in FHS Third Generation cohort exam 2 participants.



Primary Outcome Measures :
  1. To relate transcriptomic variation to CVD and its risk factors (bloodpressure, lipids, glycemia, adiposity, smoking, and alcohol), includingevaluating RNAs as biomarkers of risk and establishing causation viaMendelian randomization [ Time Frame: Observational ]
  2. To relate complex transcriptomic variation to other blood-based omics [ Time Frame: Observational ]
  3. To determine the association of genetic sequence variation fromwhole genome sequencing with gene expression via RNA-seq: Identify genetic variants associated with alternative splicing (sQTLS) [ Time Frame: Observational ]
  4. To determine the association of genetic sequence variation fromwhole genome sequencing with gene expression via RNA-seq: Identify genetic variants associated with expression of protein coding RNAs (eQTLs) [ Time Frame: Observational ]
  5. To determine the association of genetic sequence variation fromwhole genome sequencing with gene expression via RNA-seq: Identify genetic variants associated with expression of lncRNAs [ Time Frame: Observational ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
We propose to extend the investigation of transcriptomics in FHS Third Generation cohort exam 2 participants.
Criteria
  • INCLUSION CRITERIA:

To accomplish the Aims of this project we propose to conduct RNA-seq on FHS Third Generation cohort participants with WGS as part of TOPMed. This can only be accomplished in FHS Third Generation cohort participants who attended exam 2 when PaxGene tubes were collected for RNA isolation. Therefore, we propose to conduct RNA-seq on FHS Third Generation cohort exam 2 attendees with PaxGene tubes (total n=3300) and in whom we will have direct or imputed WGS from TOPMed (n=1700).


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03225183


Locations
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United States, Massachusetts
Framingham Heart Study
Framingham, Massachusetts, United States, 01702
Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Daniel Levy, M.D. National Heart, Lung, and Blood Institute (NHLBI)

Publications:

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Responsible Party: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT03225183     History of Changes
Other Study ID Numbers: 999917133
17-H-N133
First Posted: July 21, 2017    Key Record Dates
Last Update Posted: March 22, 2019
Last Verified: June 14, 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) ):
TOPMed
Blood Pressure
Long Noncoding RNA
Gene Expression
MicroRNA

Additional relevant MeSH terms:
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Cardiovascular Diseases