Analysis of Calcium Score of Severe Aortic Stenosis in Patients With and Without Cardiac Amyloidosis (CAUSATIVE Study)

NCT06066632 | Unknown

• 1 other identifier: 72/2022/Oss/AOUFe
• Study Type: observational
• Target: 480
• Locations: 1 country
• Sites: 1

Brief Summary

The concomitant presence of cardiac amyloidosis (CA) in patients with aortic stenosis (AS) may challenge the estimation of stenosis degree. In patients with dual pathology (AS + CA) the most frequent AS hemodynamic profile is paradoxical low-flow, low-gradient AS. In this setting, estimating stenosis degree with cardiac ultrasound may be challenging and aortic valve calcium score estimation by cardiac CT is a valuable exam. Preliminary findings from small case series showed that patients with severe AS and CA presented less valvular calcium deposition compared to patients with severe AS alone. On this basis, confirmation of these findings would have a huge clinical impact on diagnosis, choice of treatment strategy and understanding of the pathophysiology of these patients. The aim of the study is to study the correlation between valvular calcium score (assessed by EKG-gated CT) and effective orifice area (assessed through echocardiogram) according to cardiac amyloidosis presence (in the overall population and among hemodynamic phenotypes of cardiac amyloidosis). As secondary endpoints the study will sought to assess TAVI/SAVR efficacy, procedural complications, in-hospital mortality, all-cause death and heart failure hospitalization at 1 year, according to absence or presence of CA.

Conditions

Amyloidosis Cardiac; Aortic Stenosis, Severe

Keywords

Amyloidosis; Aortic stenosis; Calcium Score; Low-flow low-gradient

Outcome Measures

Primary Outcomes (1)

• Correlation between valvular calcium score and effective orifice area.

  Correlation between valvular calcium score (assessed by EKG-gated CT) and effective orifice area (assessed through echocardiogram) according to cardiac amyloidosis presence (in the overall population and among hemodynamic phenotypes of cardiac amyloidosis).

  Up to 12 months

Secondary Outcomes (5)

• TAVI/SAVR efficacy

  At time of post-procedural echocardiographic assessment (through study completion, an average of 1 month)

• TAVI/SAVR efficacy

  At time of post-procedural echocardiographic assessment (through study completion, an average of 1 month)

• Procedural Complications

  At an average of 12 months

• In-hospital Mortality

  At an average of 12 months

• All-cause Mortality and Heart Failure Hospitalization

  At an average of 12 months

Study Arms (2)

Group 1 - "Dual Pathology"

* Age \>65 years * Severe aortic stenosis at echocardiographic examination * TAVI o SAVR planned or already undergone TAVI/SAVR * ECG-gated cardiac CT and echocardiographic examinations available before TAVI/SAVR * Cardiac uptake at bone tracer scintigraphy with a Perugini score of 2 or 3.

Group 2- "Control Group"

* Age \>65 years * Severe aortic stenosis at echocardiographic examination * TAVI o SAVR planned or already undergone TAVI/SAVR * ECG-gated cardiac CT and echocardiographic examinations available before TAVI/SAVR * Patients with no cardiac uptake at scintigraphy with bone tracer.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Group 1 "DUAL PATHOLOGY" * Age \>65 years * Severe aortic stenosis at echocardiographic examination * TAVI o SAVR planned or already undergone TAVI/SAVR * ECG-gated cardiac CT and echocardiographic examinations available before TAVI/SAVR * Cardiac uptake at bone tracer scintigraphy with a Perugini score of 2 or 3. Group 2 "CONTROL GROUP" * Age \>65 years * Severe aortic stenosis at echocardiographic examination * TAVI o SAVR planned or already undergone TAVI/SAVR * ECG-gated cardiac CT and echocardiographic examinations available before TAVI/SAVR * patients with no cardiac uptake at scintigraphy with bone tracer.

You may qualify if:

• 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

You may not qualify if:

• suboptimal acoustic window that may undermine the assessment of AS severity and phenotype profiling

Sponsors & Collaborators

• University Hospital of Ferrara: lead

Study Sites (1)

University Hospital of Ferrara

Ferrara, 44124, Italy

RECRUITING

Related Publications (2)

• Hussan et al. Aortic Valve Calcium Score Cut-Offs Used To Identify Hemodynamically Severe Aortic Stenosis May Not Apply In Patients With Cardiac Amyloidosis. ACC.20 World Congress of Cardiology (https://www.jacc.org/doi/abs/10.1016/S0735-1097%2820%2932791-1)

  BACKGROUND

• Hussain M, Hanna M, Griffin BP, Conic J, Patel J, Fava AM, Watson C, Phelan DM, Jellis C, Grimm RA, Rodriguez LL, Schoenhagen P, Hachamovitch R, Jaber WA, Cremer PC, Collier P. Aortic Valve Calcium in Patients With Transthyretin Cardiac Amyloidosis: A Propensity-Matched Analysis. Circ Cardiovasc Imaging. 2020 Oct;13(10):e011433. doi: 10.1161/CIRCIMAGING.120.011433. Epub 2020 Sep 23. No abstract available.

  PMID: 32967445 RESULT

MeSH Terms

Conditions

Amyloid Neuropathies, Familial; Aortic Valve Stenosis; Amyloidosis

Condition Hierarchy (Ancestors)

Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Nervous System Diseases; Amyloid Neuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Amyloidosis, Familial; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases; Proteostasis Deficiencies; Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Matteo Serenelli, Doctor

  Azienda Ospedaliero Universitaria di Ferrara

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matteo Serenelli, Doctor

CONTACT

0532236269; m.serenelli@ospfe.it

Paolo Cimaglia, Doctor

CONTACT

0532236269; p.cimaglia@ospfe.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: September 15, 2023
• First Posted: October 4, 2023
• Study Start: June 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: June 1, 2024
• Last Updated: October 4, 2023

Record last verified: 2023-09

Locations

IT (1)