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NCT01980797 · ClinicalTrials.gov registry record
International Bicuspid Aortic Valve Consortium (BAVCon)
A clinical trial of Bicuspid Aortic Valve Disease and Thoracic Aortic Disease in Patients With a Bicuspid Aortic Valve, sponsored by Boston University.
- Active
- Registry status
- 10,000
- Enrollment target
- 12
- Study locations
NCT01980797: Active study of Bicuspid Aortic Valve Disease and Thoracic Aortic Disease in Patients With a Bicuspid Aortic Valve, sponsored by Boston University.
NCT01980797 is a study of Bicuspid Aortic Valve Disease and Thoracic Aortic Disease in Patients With a Bicuspid Aortic Valve that is active but no longer recruiting, run by Boston University. The registered enrollment target is 10,000 participants. The trial reports 12 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01980797, a study of Bicuspid Aortic Valve Disease and Thoracic Aortic Disease in Patients With a Bicuspid Aortic Valve, is active but no longer recruiting, sponsored by Boston University.
- ACTIVE NOT RECRUITING
- Registry status
- 10,000 participants
- Enrollment target
- 12
- Study locations
Study Summary
Bicuspid aortic valve (BAV) disease is the most frequent congenital cardiac malformation, occurring in 0.5-1.2% of the US population. In young adults, it is generally a benign abnormality; but in older adults it is associated with thoracic aortic aneurysm or dissection in 20-30% of those with BAV. BAV is strongly associated with early development of aortic valve calcification or incompetence in \>50% of BAV patients, and accounts for \~40% of the \>30,000 aortic valve replacements (AVR) performed in the US each year. Yet, we know little of the etiology, cellular events and modifiers of progression of BAV to calcific aortic valve disease and we still do not understand the genetic cause(s) of BAV despite evidence for its high heritability. The Specific Aims of this study are: 1. To identify the genetic causes of bicuspid aortic valve disease and its associated thoracic aortic disease. 2. To identify potential pathways to predict the clinical course of BAV disease and for treating human BAV disease. To achieve these aims, we have created the International Bicuspid Aortic Valve Consortium (BAVCon), a consortium of institutions with cohorts of BAV patients and the expertise to fulfill the performance of these aims.
Primary Outcome
The first specific aim is to identify the genetic causes of bicuspid aortic valve disease.
Conditions Studied
Study Locations (12)
Other
- Monaldi Hospital - Naples
- Second University of Naples - Naples
- University of Salerno - Salerno
- Hospital Vall d'Hebron - Barcelona
- University of Oxford - Oxford
Massachusetts
- Tufts Medical Center - Boston
- Boston Medical Center - Boston
Michigan
- University of Michigan - Ann Arbor
Minnesota
- Mayo Clinic - Rochester
Texas
- University of Texas Health Science Center at Houston - Houston
Quebec
- Laval University - Québec
Milan
- Istituto Policlinico San Donato - San Donato Milanese
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10,000 participants |
| Start Date | 2013-11 |
| Est. Completion | 2028-11 |
What the registry record for NCT01980797 still lists
NCT01980797 is an observational study that tracks outcomes without assigning an intervention. Its 10,000 participants enrollment target places it among the larger protocols in the corpus.
The record links to 2 conditions, with Bicuspid Aortic Valve Disease appearing as the primary indexed condition, and to 0 interventions.
NCT01980797 lists 12 locations in 7 states (Other, Massachusetts, Michigan).
Frequently Asked Questions
What is clinical trial NCT01980797 about?
NCT01980797 is a clinical study titled "International Bicuspid Aortic Valve Consortium (BAVCon)". Bicuspid aortic valve (BAV) disease is the most frequent congenital cardiac malformation, occurring in 0.5-1.2% of the US population. In young adults, it is generally a benign abnormality; but in older adults it is associated with thoracic aortic aneurysm or dissection in 20-30% of those with BAV. B...
What is the current status of trial NCT01980797?
This trial is currently active not recruiting. The enrollment target is 10,000 participants. The study started on 2013-11. Estimated completion is 2028-11.
What conditions does trial NCT01980797 study?
This clinical trial studies the following conditions: Bicuspid Aortic Valve Disease, Thoracic Aortic Disease in Patients With a Bicuspid Aortic Valve.
Who is sponsoring clinical trial NCT01980797?
This trial is sponsored by Boston University, which has 185 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01980797 being conducted?
This trial has 12 study locations across Massachusetts, Michigan, Minnesota, Texas, Quebec. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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