Cardiac Imaging in congenital aortic stenosis: unravelling risk factors and predicting clinical outcome

Cardiac Imaging in congenital aortic stenosis: unravelling risk factors and predicting clinical outcome - CAS

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON52322

Enrollment

100

Registered

2021-11-22

Start date

2022-01-13

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

bicuspid aortic valve Congenital aortic stenosis

Interventions

None listed

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: The study population consists of 100 adult ConAoS patients, who are visiting the outpatient clinic of the Erasmus MC. In order to be eligible to participate in this study, a subject must meet the following criteria: • Aged >= 18 years • Capable of understanding and signing informed consent. Inclusion criteria for the CAS study are patients diagnosed with a valvular congenital aortic stenosis. Two groups of patients will be included: • Patients with a prior aortic valve replacement (AVR) • Patients without a prior AVR and with an aortic jet velocity >= 2.5 m/s.

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: • Patients with severe aortic regurgitation • Presence of any of the following contra-indications for MRI o Contra-indication to gadolinium based contrast media (eGFR

Design outcomes

Primary

Measure	Time frame
The main study parameters are the prevalence and patterns of myocardial fibrosis.	—

Secondary

Measure	Time frame
Secondary study parameters that will be determined at baseline include: • Left ventricular function and dimensions, measured by echocardiography (speckle tracking echocardiography with strain and strain rate measurements as strain volume loops) and CMR (SSFP cine images for ejection fraction and strain measurements) • Shear wave velocity, measured using high frame rate echocardiography. • Flow patterns, measured by 4D flow MRI • Physical activity in daily life, measured by questionnaires (TSK-NL Heart and SQUASH) • Blood biomarkers • Conduction abnormalities and arrhythmias, measured by Holter ECG and ECG • Supraventricular and ventricular arrhythmias measured by Holter ECG and ECG • Quality of life, assessed by using a questionnaire (SF-36) Additionally, patients will be followed clinically for the duration of 3 years. Clinical outcome will be assessed with all-cause mortality, incident heart failure, arrhythmias, endocarditis, aortopathy, (re-) interventions and operations of the aortic valve and/or ascending aorta and hospitalization for other cardiac reasons as endpoints.	—

Measure

Time frame

Secondary study parameters that will be determined at baseline include: • Left ventricular function and dimensions, measured by echocardiography (speckle tracking echocardiography with strain and strain rate measurements as strain volume loops) and CMR (SSFP cine images for ejection fraction and strain measurements) • Shear wave velocity, measured using high frame rate echocardiography. • Flow patterns, measured by 4D flow MRI • Physical activity in daily life, measured by questionnaires (TSK-NL Heart and SQUASH) • Blood biomarkers • Conduction abnormalities and arrhythmias, measured by Holter ECG and ECG • Supraventricular and ventricular arrhythmias measured by Holter ECG and ECG • Quality of life, assessed by using a questionnaire (SF-36) Additionally, patients will be followed clinically for the duration of 3 years. Clinical outcome will be assessed with all-cause mortality, incident heart failure, arrhythmias, endocarditis, aortopathy, (re-) interventions and operations of the aortic valve and/or ascending aorta and hospitalization for other cardiac reasons as endpoints.

—

Countries

Netherlands

Outcome results