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

Primary Purpose

Transthyretin Cardiac Amyloidosis

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Bony scintigraphy
Sponsored by
Poitiers University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Transthyretin Cardiac Amyloidosis focused on measuring cardiology

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • C.H.U. de Poitiers

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bony scintigraphy

Arm Description

Bony scintigraphy within 1 to 4 months after inclusion

Outcomes

Primary Outcome Measures

Percentage of patients with a positive bone scintigraphy (perugini score> or = 2) in the absence of AL cardiac amyloidosis.
Percentage of patients with a positive bone scintigraphy (perugini score> or = 2) in the absence of AL cardiac amyloidosis in patients over 60 years hospitalised in cardiology wards, with an hypertrophy of the left ventricle on transthoracic echocardiography (thickness of the left ventricle at the end of diastole >12mm), whatever the possible cause of hypertrophy of the left ventricle (other potential cause not excluded), and without prior diagnosis of cardiac amylosis.

Secondary Outcome Measures

Full Information

First Posted
August 26, 2021
Last Updated
September 8, 2023
Sponsor
Poitiers University Hospital
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT05064839
Brief Title
Imaging for the Evaluation of Transthyretin Cardiac Amyloidosis Prevalence of Patients Over 65 Hospitalized in Cardiology Wards (the IMPACT Study)
Acronym
IMPACT
Official Title
Imaging for the Evaluation of Transthyretin Cardiac Amyloidosis Prevalence of Patients Over 65 Hospitalized in Cardiology Wards (the IMPACT Study)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
October 6, 2021 (Actual)
Primary Completion Date
August 18, 2023 (Actual)
Study Completion Date
August 18, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poitiers University Hospital
Collaborators
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
Not Provided

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transthyretin Cardiac Amyloidosis
Keywords
cardiology

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
553 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bony scintigraphy
Arm Type
Experimental
Arm Description
Bony scintigraphy within 1 to 4 months after inclusion
Intervention Type
Procedure
Intervention Name(s)
Bony scintigraphy
Intervention Description
Bony scintigraphy (99mTc-Hydromethylene diphosphonate) will be performed in all patients with hypertrophy of the left ventricle
Primary Outcome Measure Information:
Title
Percentage of patients with a positive bone scintigraphy (perugini score> or = 2) in the absence of AL cardiac amyloidosis.
Description
Percentage of patients with a positive bone scintigraphy (perugini score> or = 2) in the absence of AL cardiac amyloidosis in patients over 60 years hospitalised in cardiology wards, with an hypertrophy of the left ventricle on transthoracic echocardiography (thickness of the left ventricle at the end of diastole >12mm), whatever the possible cause of hypertrophy of the left ventricle (other potential cause not excluded), and without prior diagnosis of cardiac amylosis.
Time Frame
At Visit 2, one to four months after inclusion visit.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
C.H.U. de Poitiers
City
Poitiers
ZIP/Postal Code
86000
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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