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Non-Interventional Study on the Prevalence of Cardiac Amyloidosis in Patients With Higher-Grade Aortic Valve Stenosis - Evaluation Using Echocardiography, Computed Tomography, Tc99-SPECT/CT and Cardiac Magnetic Resonance Imaging (CMR)

Recruitingn/aAges 18 Years - anyAllUniversity Hospital Tuebingen
NCT07752732 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Degenerative aortic stenosis (AS) is frequently accompanied by left ventricular hypertrophy and diastolic dysfunction, features that overlap with transthyretin (ATTR) cardiac amyloidosis. Because concomitant cardiac amyloidosis may adversely affect outcomes after transcatheter aortic valve implantation (TAVI), its early detection is clinically important. This prospective observational study aims to evaluate multimodal imaging biomarkers for the detection and characterization of cardiac amyloidosis in patients with severe AS undergoing TAVI evaluation. Clinically indicated technetium-99m phosphonate SPECT/CT and CT will be used to assess the presence and extent of cardiac amyloidosis, including quantitative measures of myocardial tracer uptake and extracellular volume. In patients with abnormal findings, cardiac magnetic resonance imaging (CMR) will be performed as an additional non-inva

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patients with severe aortic valve stenosis (valve opening area \<1 cm², pmean \>40 mmHg, Vmax \>4 m/sec) * Suspected cardiac amyloidosis * Performance of one or more of the following imaging examinations due to (justifiable) clinical indication: echocardiography, photon-counting computed tomography (CT), Tc99-SPECT/CT, cardiac MRI * Age ≥18 years * Written consent of the patient for prospective data collection regarding Tc99-SPECT/CT, CT, and, if applicable, CMR and follow-up Exclusion Criteria: • patients unable to give consent
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What it tests

  • Not listed
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Where

1 site
University Hospital of Tuebingen
Tübingen, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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