Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-24 @ 10:22 PM
NCT ID:
NCT06021535
Eligibility Criteria:
Inclusion Criteria:
* Group of patients with CAS:
* Calcified aortic stenosis diagnosed on a cardiac ultrasound or CT not older than 3 months
* Severe aortic stenosis: surgical indication based on symptoms and ultrasound data (high gradient aortic stenosis : Vmax\> 4m/s, mean gradient \> 40mmHg, area \< 1cm², low flow low-gradient CAS: left ventricular ejection fraction (LVEF) \< 40%, Vmax\< 4m/s, mean gradient \< 40mmHg, area \< 1cm², paradoxical low-gradient CAS: LVEF \> 55%, Vmax\< 4m/s, mean gradient \< 40mmHg, area \< 1cm²)
* Moderate CAS: 3m/s \<Vmax\< 4m/s, 20mmHg \< mean gradient \< 40mmHg
* Mild CAS: 2,6m/s \< Vmax \< 2.9m/s, mean gradient \< 20mmHg
* Aortic sclerosis: calcified remodeling of the aortic valve visible on ultrasound or CT.
Control group - free of CAS:
\- No calcified aortic stenosis verified on a cardiac ultrasound or CT not older than 3 months
Exclusion Criteria:
* Treatment interfering with the composition of the intestinal microbiota: local or systemic corticosteroids within the last 3 months, antibiotics within the last 3 months, antiretrovirals, bile acid chelators (questran and colesevelam), HIV-targeted antiretroviral therapies, selective serotonin reuptake inhibitor-type antidepressants
* Clinical criteria: history of cholecystectomy, documented chronic liver disease in the patient, failure to fast on the day of the blood test, inflammatory bowel disease
* Patients requiring emergency intervention (myocardial infarction, acute aortic or mitral insufficiency, cardiogenic shock).
* AS of rheumatic origin, infective endocarditis.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT06021535
Study Brief:
Protocol Section:
NCT06021535