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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT01322165
First received: March 22, 2011
Last updated: August 11, 2014
Last verified: September 2013

March 22, 2011
August 11, 2014
November 2007
September 2015   (final data collection date for primary outcome measure)
Thoracic aortic aneurysms and dissections and their associated surgical interventions [ Time Frame: bi-annual ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT01322165 on ClinicalTrials.gov Archive Site
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National Registry of Genetically Triggered Thoracic Aortic Aneurysms and Cardiovascular Conditions
National Registry of Genetically Triggered Thoracic Aortic Aneurysms and Cardiovascular Conditions

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). The goal of GenTAC is to establish a registry of patients with genetic conditions that may be related to thoracic aortic aneurysms and to collect medical data and biologic samples. The samples and data will be made available to qualified investigators to enable research to determine best medical practices and to advance the clinical management of genetic thoracic aortic aneurysms, and other cardiovascular complications. Over 3600 subjects have been enrolled into the registry.

Eligible subjects must be seen in person at one of the participating locations. Contact the study coordinator at the location nearest you for more information about participation. This study does not provide genetic testing.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples With DNA
Description:

If a blood specimen is obtained, it is separated and stored as plasma, viable cells, and extracted DNA. If a saliva specimen is obtained, it is stored for DNA.

Non-Probability Sample

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

  • 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 Dissections
  • Shprintzen-Goldberg Syndrome
  • Other Aneur/Diss of Thoracic Aorta Not Due to Trauma, <50yo
  • Other Congenital Heart Disease
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
3800
September 2015
September 2015   (final data collection date for primary outcome measure)

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.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01322165
1438, N01-HV-08238, N01-HV-68199
Yes
National Heart, Lung, and Blood Institute (NHLBI)
National Heart, Lung, and Blood Institute (NHLBI)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
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
National Heart, Lung, and Blood Institute (NHLBI)
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP