Overview

This trial is active, not recruiting.

Conditions 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
Sponsor National Heart, Lung, and Blood Institute (NHLBI)
Collaborator National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Start date November 2007
End date September 2015
Trial size 3800 participants
Trial identifier NCT01322165, 1438, 268201000048C-5-0-1, N01HV68199-7-0-1

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
Thoracic aortic aneurysms and dissections and their associated surgical interventions
time frame: bi-annual

Eligibility Criteria

Male or female participants of any age.

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.

Additional Information

Official title National Registry of Genetically Triggered Thoracic Aortic Aneurysms and Cardiovascular Conditions
Principal investigator Richard Devereux, MD
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by National Heart, Lung, and Blood Institute (NHLBI).