Analyzing Calcium Scores in Patients with Severe Aortic Stenosis and Cardiac Amyloidosis
Analysis of Calcium Score Values of Severe Aortic Stenosis in Patients With and Without Cardiac Amyloidosis (CAUSATIVE Study)
This study is trying to see how calcium buildup in the heart affects the severity of aortic stenosis in patients who also have cardiac amyloidosis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 480 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | University Hospital of Ferrara Academic / other |
| Locations | 1 site (Ferrara) |
| Trial ID | NCT06066632 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the relationship between valvular calcium scores, assessed through EKG-gated CT, and effective orifice area, evaluated via echocardiogram, in patients with severe aortic stenosis who may also have cardiac amyloidosis. The study focuses on understanding how the presence of cardiac amyloidosis affects the estimation of aortic stenosis severity, particularly in cases with paradoxical low-flow, low-gradient profiles. By confirming preliminary findings that suggest patients with both conditions may have less calcium deposition, the study seeks to enhance diagnostic accuracy and treatment strategies for this dual pathology.
Who should consider this trial
Good fit: Ideal candidates for this study are patients aged 65 and older with severe aortic stenosis who are planned for or have undergone TAVI or SAVR and show signs suggestive of cardiac amyloidosis.
Not a fit: Patients with suboptimal acoustic windows that hinder the assessment of aortic stenosis severity may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic methods and treatment strategies for patients suffering from both severe aortic stenosis and cardiac amyloidosis.
How similar studies have performed: Preliminary findings from small case series suggest that the approach taken in this study may yield significant insights, although it remains to be fully validated in larger cohorts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * signed informed consent * age ≥65 years old * severe AS * planned or performed TAVI/SAVR * at least one red-flag suggestive of CA * availability of EKG-gated CT * availability of echocardiogram performed before TAVI/SAVR * availability of bone scintigraphy performed within 1 year from CT Exclusion Criteria: • suboptimal acoustic window that may undermine the assessment of AS severity and phenotype profiling
Where this trial is running
Ferrara
- University Hospital of Ferrara — Ferrara, Italy (Recruiting)
Study contacts
- Principal investigator: Matteo Serenelli, Doctor — Azienda Ospedaliero Universitaria di Ferrara
- Study coordinator: Matteo Serenelli, Doctor
- Email: m.serenelli@ospfe.it
- Phone: 0532236269
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.