National Registry of Genetically Triggered Thoracic Aortic Aneurysms and Cardiovascular Conditions (GenTAC)

December 19, 2016 updated by: National Heart, Lung, and Blood Institute (NHLBI)
The National Registry of Genetically Triggered Thoracic Aortic Aneurysms and Cardiovascular Conditions (GenTAC) was initiated in 2006 by the National Heart, Lung, and Blood Institute (NHLBI) and the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). GenTAC established a registry of 3706 patients with genetic conditions that may be related to thoracic aortic aneurysms and collected medical data and biologic samples. The study ended in September 2016. Data and samples are available from NHLBI and requests should be made to BioLINCC. See the NHLBI website for more information: https://www.nhlbi.nih.gov/research/resources/gentac/.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

3706

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • Queens Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins University
    • New York
      • New York, New York, United States, 10021
        • The New York Presbyterian Hospital-Weill Cornell Medical Center
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104-4283
        • University of Pennsylvania School of Medicine
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
      • Houston, Texas, United States, 77030
        • University of Texas Medical School at Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The cohort consists of patients with conditions related to genetically-induced thoracic aortic aneurysms.

Description

Eligible subjects must have one of the conditions listed below and be enrolled in-person at one of the participating clinical centers.Contact the study coordinator at the location nearest you for more information about participation.

  • Marfan syndrome
  • Turner syndrome
  • Ehlers-Danlos syndrome
  • Loeys-Dietz syndrome
  • FBN1, TGFBR1, TGFBR2, ACTA2 or MYH11 genetic mutation
  • Bicuspid aortic valve without known family history
  • Bicuspid aortic valve with family history
  • Bicuspid aortic valve with coarctation
  • Familial Thoracic Aortic Aneurysm and DissectionsYes
  • Shprintzen-Goldberg syndrome
  • Other aneurysms and dissections of the thoracic aorta not due to trauma, <50yo
  • Other congenital heart disease (e.g., Tetralogy of Fallot, coarctation)

Exclusion Criteria:

  • Inability of the patient, parent or guardian to give consent.
  • Unwillingness to provide a blood or buccal specimen.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Thoracic aortic aneurysms and dissections and their associated surgical interventions
Time Frame: bi-annual
bi-annual

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborators

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Investigators

  • Study Director: Barbara Kroner, PhD, MPH, RTI International
  • Principal Investigator: Richard Devereux, MD, The New York Presbyterian Hospital-Weill Cornell Medical Center
  • Principal Investigator: William Ravekes, M.D., Johns Hopkins University
  • Principal Investigator: Reed E. Pyeritz, M.D., Ph.D., University of Pennsylvania
  • Principal Investigator: Dianna M. Milewicz, M.D. Ph.D., University of Texas Medical School at Houston
  • Principal Investigator: Scott A. LeMaire, M.D., Baylor College of Medicine
  • Principal Investigator: Cheryl L. Maslen, Ph.D., Oregon Health and Science University
  • Principal Investigator: Ralph Shohet, MD, University of Hawaii
  • Principal Investigator: Jennifer Habashi, MD, Johns Hopkins University
  • Principal Investigator: Federico M. Asch, MD,FACC,FASE, Medstar
  • Study Chair: Kim Eagle, M.D., University of Michigan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

March 22, 2011

First Submitted That Met QC Criteria

March 22, 2011

First Posted (Estimate)

March 24, 2011

Study Record Updates

Last Update Posted (Estimate)

December 20, 2016

Last Update Submitted That Met QC Criteria

December 19, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1438
  • 268201000048C-5-0-1 (U.S. NIH Grant/Contract)
  • N01HV68199-7-0-1 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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