Prospective 4D CTA of BAV Competence

Bicuspid Clinical Trial

Official title:

Prospective 4D CTA of BAV Competence

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04645862
• Other study ID #: 843190
• Status: Recruiting
• Start date: December 1, 2020
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bicuspid
• Bicuspid Aortic Valve Disease

Intervention

Diagnostic Test:
• CT scans
4D CTA imaging

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cusp surface areas over the cardiac cycle	Surface area of each cusp in mm2 in one cardiac cycle (~0.6 - 1s in length). This measurement is made directly from the CT image.	Through study completion, an average of 1 year
Primary	Cusp height (geometric and effective)	Geometric and effective cusp height in mm in one cardiac cycle (~0.6 - 1s in length). This measurement is made directly from the CT image.	Through study completion, an average of 1 year
Primary	Cusp free margin length	Length of the free margin of each cusp in mm in one cardiac cycle (~0.6 - 1s in length). This measurement is made directly from the CT image.	Through study completion, an average of 1 year
Primary	Cusp thickness (including raphe thickness, if applicable)	Thickness of each cusp in mm in one cardiac cycle (~0.6 - 1s in length). This measurement is made directly from the CT image.	Through study completion, an average of 1 year
Primary	Commissural height	Height of each commissure in mm in one cardiac cycle (~0.6 - 1s in length). This measurement is made directly from the CT image.	Through study completion, an average of 1 year
Primary	Sino tubular junction size	Diameter of the sinotubular junction in mm in one cardiac cycle (~0.6 - 1s in length). This measurement is made directly from the CT image.	Through study completion, an average of 1 year
Primary	Size of the sinuses of Valsalva	Maximum diameter of the sinuses of Valsalva (mid-level of the aortic root) in mm in one cardiac cycle (~0.6 - 1s in length). This measurement is made directly from the CT image.	Through study completion, an average of 1 year
Primary	Ventriculoaortic junction size	Diameter of the ventriculoaortic junction in mm in one cardiac cycle (~0.6 - 1s in length). This measurement is made directly from the CT image.	Through study completion, an average of 1 year
Primary	Aortic annulus size	Diameter of the aortic cusp in mm measured in one cardiac cycle (~0.6 - 1s in length). This measurement is made directly from the CT image.	Through study completion, an average of 1 year
Primary	Coaptation height at diastole	Length of the coaptation zone of the cusps in mm when the valve is closed. This measurement is made in one cardiac cycle (~0.6 - 1s in length) from the CT image.	Through study completion, an average of 1 year
Primary	Cusp displacement over the cardiac cycle	Total displacement of the center of the free margin of each cusp in mm during one cardiac cycle (~0.6 - 1s in length). This measurement is made directly from the CT image.	Through study completion, an average of 1 year
Primary	Cusp velocity over the cardiac cycle	Maximum velocity of the center of the free margin of each cusp in mm/s during one cardiac cycle (~0.6 - 1s in length). This measurement is made directly from the CT image.	Through study completion, an average of 1 year
Primary	Size of the ascending aorta	Maximum diameter of the ascending aorta in cm during one cardiac cycle (~0.6 - 1s in length). This measurement is made directly from the CT image.	Through study completion, an average of 1 year
Secondary	Development of aortic insufficiency and/or stenosis.	Degree of aortic insufficiency as measured on standard-of-care echocardiography	Through study completion, an average of 1 year
Secondary	Development of aortic insufficiency and/or stenosis.	The need for surgical intervention for disease of the aortic valve and/or ascending aorta	Through study completion, an average of 1 year