Clinical trial NCT04645862: Prospective 4D CTA of BAV Competence
Official title: Prospective 4D CTA of BAV Competence
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bicuspid
Keywords: bicuspid aortic valve
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2020-11-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Bicuspid aortic valve identified via clinical imaging

Brief summary: The study involves annual 4D CTA imaging of the bicuspid aortic valve for a period of 5 years. CTA is often standard of care for BAV patients, but patients in this study will receive a higher radiation dose with a 4D imaging protocol. There may also be patients enrolled in the study who have a 4D CTA for research purposes when a routine CTA is not required for clinical care.

Detailed description: The bicuspid aortic valve (BAV) is the most common congenital heart disease. The purpose of this study is to better understand the anatomy of physiologically normal, or competent, BAVs without stenosis or insufficiency (AI) in order to support evidence-based standardization of BAV repair surgery. Men and women over 18 years of age with a diagnosis of BAV and minimal aortic valve calcification at baseline will undergo annual 4D computed tomography angiography (CTA) scans, routine transthoracic echocardiograms, and history and physical assessments over the course of the 5-year study period. Patients who are pregnant, have renal insufficiency (creatinine 2 mg/dL), or who have a contraindication to intravenous contrast will be excluded. Patients will be stratified into study groups according to baseline AI: approximately half of patients will have no to mild AI at baseline and the other half will have moderate to severe AI at baseline. Anatomical measurements will be obtained from the 4D CTA scans and analyzed at each phase of the cardiac cycle, as well as longitudinally. The 4D CTA imaging and analysis will not impact medical care of the study participants; the anatomical measurements will be used in the future as evidence-based standards for determining valve repair candidacy for BAV patients with AI.

Eligibility criteria: Inclusion Criteria:

* At least 18 years of age
* Documented bicuspid aortic valve identified via clinical imaging (e.g., CT, MRI, or echocardiogram) with minimal calcification at the time of enrollment
* Participant must sign the informed consent form

Exclusion Criteria:

* Pregnancy (determined by point of care urine pregnancy test)
* Renal failure (estimated Glomerular Filtration Rate (eGFR) \< 30), precluding them from receiving intravenous contrast)
* Documentation of previous intravenous contrast allergy (unless they are having a CT with steroid preparation as part of routine clinical care)
* Previous aortic valve replacement

Primary outcomes:
measure: Cusp surface areas over the cardiac cycle
timeFrame: Through study completion, an average of 1 year
measure: Cusp height (geometric and effective)
timeFrame: Through study completion, an average of 1 year
measure: Cusp free margin length
timeFrame: Through study completion, an average of 1 year
measure: Cusp thickness (including raphe thickness, if applicable)
timeFrame: Through study completion, an average of 1 year
measure: Commissural height
timeFrame: Through study completion, an average of 1 year
measure: Sino tubular junction size
timeFrame: Through study completion, an average of 1 year
measure: Size of the sinuses of Valsalva
timeFrame: Through study completion, an average of 1 year
measure: Ventriculoaortic junction size
timeFrame: Through study completion, an average of 1 year
measure: Aortic annulus size
timeFrame: Through study completion, an average of 1 year
measure: Coaptation height at diastole
timeFrame: Through study completion, an average of 1 year
measure: Cusp displacement over the cardiac cycle
timeFrame: Through study completion, an average of 1 year
measure: Cusp velocity over the cardiac cycle
timeFrame: Through study completion, an average of 1 year
measure: Size of the ascending aorta
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Development of aortic insufficiency and/or stenosis.
timeFrame: Through study completion, an average of 1 year
measure: Development of aortic insufficiency and/or stenosis.
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
References: