on-interventional study on the prevalence of cardiac amyloidosis in patients with higher-grade aortic valve stenosis - evaluation using Tc99-SPECT / CT and cardiac MRI (CMR)

Recruiting

• Conditions: I08; Multiple valve diseases

• Registration Number: DRKS00020481
• Lead Sponsor: niversitätsklinikum Tübingen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-14
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Patients with higher grade aortic stenosis (valve opening area <1cm², pmean> 40mmHg, vmax> 4m / sec),
performing a Tc99-SPECT / CT based on justifying clinical indication,
age =18 years,
written consent of the patient for prospective data collection regarding Tc99-SPECT / CT, possibly regarding CMR and follow-up.

Exclusion Criteria

Patients unable to give consent.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determination of the prevalence of cardiac amyloidosis in patients with higher grade aortic valve stenosis - evaluation using non-invasive imaging: SPECT/CT or cardiac MRI (CMR).

Secondary Outcome Measures

Name	Time	Method
Correlation of cardiac MRI (T1/T2 mapping) to quantitative SPECT / CT evaluation.<br>Follow-up of the patients with regard to the prognostic relevance of the imaging examinations for any undesirable cardiac events in an observation period of 2 years.