Imaging for the Evaluation of Transthyretin Cardiac Amyloidosis Prevalence of Patients Over 65 Hospitalized in Cardiology Wards (the IMPACT Study)

P

Poitiers University Hospital

Status and phase

Completed
Phase 3

Conditions

Transthyretin Cardiac Amyloidosis

Treatments

Procedure: Bony scintigraphy

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT05064839
2021-A00732-39

Details and patient eligibility

About

Heart failure with preserved ejection and hypertrophic cardiomyopathy are common diseases and often associated with transthyretin cardiac amyloidosis (TTR-CM), especially in elderly people. Nevertheless, research of TTR-CM is recommended in patients with ventricular hypertrophy without other cause such as valvular disease or hypertension. Therefore, the exact prevalence of TTR-CM remains unknown. We aim to determine the prevalence of TTR-CM in patients with ventricular hypertrophy and aged ≥ 60 years old, hospitalized in our cardiology department (CHU de Poitiers) by performing bone scintigraphy and research of AL amyloidosis.

Full description

Not Provided

Enrollment

553 patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patient ≥ 60 years, hospitalised in cardiology wards of the Centre Hospitalier Universitaire of Poitiers
  • Left ventricle hypertrophy on echocardiography
  • Patient able to comply with study procedures
  • Patient legally free and not subject to any custody, guardianship, tutelage or subordination measures
  • Patient having signed an informed consent after clear and fair information on the study

Exclusion criteria

  • CardiacTransplant
  • Complex congenital cardiopathies
  • Know diagnosis of amylosis
  • Contra-indication to bony scintigraphy : hypersensitivity to sodium oxidronate or one of its excipients, or to one of the components of radiopharmaceutic marked product ;
  • Subject not able to comply with study procedures
  • Patients not benefiting from a Social Security scheme or not benefiting from it through a third party
  • Persons benefiting from enhanced protection, namely minors, persons deprived of their liberty by a judicial or administrative decision, patients staying in a health or social establishment, adults under legal protection, and patients in emergency situation.
  • Women not menopausal

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

553 participants in 1 patient group

Bony scintigraphy
Experimental group
Description:
Bony scintigraphy within 1 to 4 months after inclusion
Treatment:
Procedure: Bony scintigraphy

Trial contacts and locations

0

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Central trial contact

Claire BOULETI, MD

Data sourced from clinicaltrials.gov

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