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Cardiac Amyloidosis Prevalence and Outcome in Aortic Stenosis Patients Undergoing Transcatheter Aortic Valve Implantation (CAMPOS-TAVI)

Primary Purpose

Aortic Stenosis

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
HDP-Tc99m bone scintigraphy
Sponsored by
CHU de Reims
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Aortic Stenosis focused on measuring Cardiac amyloïdosis, aortic stenosis, transthyretine amyloïdosis, CA-TTR, transcatheter aortic valve implantation, TAVI, prevalence, outcome, survival

Eligibility Criteria

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

inclusion criteria :

  • patients over 60 years old
  • Patients admitted in Reims university cardiology department for per-cutaneous aortic valve replacement due to severe aortic stenosis
  • Patients enrolled in the national healthcare insurance program
  • Patients consenting to participate to the study

exclusion criteria :

- AL amyloïdosis patients

Sites / Locations

  • Damien JOLLYRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

patients undergoing transcatheter aortic valve implantation

Arm Description

patients undergoing transcatheter aortic valve implantation for aortic stenosis

Outcomes

Primary Outcome Measures

transthyretine cardiac amyloïdosis
Transthyretine cardiac amyloïdosis will be diagnosed using HDP-99mTc bone scintigraphy. The examination will consist of the injection of 10 MBq / kg of 99mTc-labeled biphosphonate, followed by a full-body scan 3 hours post-injection to produce a front thoracic static image and a tomographic image of the thorax. A positive HDP-Tc99m bone scintigraphy will be defined according to the Perugini classification corresponding to stages 2 and 3 (myocardial fixation of intensity equal to or greater than the bone structures).

Secondary Outcome Measures

Full Information

First Posted
November 20, 2020
Last Updated
May 19, 2022
Sponsor
CHU de Reims
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1. Study Identification

Unique Protocol Identification Number
NCT05384418
Brief Title
Cardiac Amyloidosis Prevalence and Outcome in Aortic Stenosis Patients Undergoing Transcatheter Aortic Valve Implantation
Acronym
CAMPOS-TAVI
Official Title
Cardiac AMyloidosis Prevalence and Outcome in Aortic Stenosis Patients Undergoing Transcatheter Aortic Valve Implantation (CAMPOS-TAVI)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 9, 2020 (Actual)
Primary Completion Date
December 9, 2021 (Actual)
Study Completion Date
December 9, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CHU de Reims

4. Oversight

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

5. Study Description

Brief Summary
Aortic stenosis (AS) is the most frequent valvulopathy in the general population in France and more generally in developed countries, due to populations aging. Its standard treatment is historically surgical aortic valve replacement (SAVR). In the 2000s, the management of this valvulopathy was revolutionized by the development of the technique of per-cutaneous aortic valve replacement (TAVI). TAVI opens the possibility of curative treatment to patients at high operational risk not operable by conventional surgery, and for whom outcome was affected with high mortality under medical treatment alone. Amyloidosis, a pathology with multiple etiologies, is a rare condition and its cardiac form (AC) even more (8 to 17 / 100,000 people / year). However, its prevalence is increasing. Some autopsies series have found prevalence up to 50% of cardiac amyloidosis with transthyretin (AC-TTR) after 60 years. In addition, recent data suggested that AC-TTR prevalence is higher in the population of patients with heart disease: 13% in heart failure with preserved ejection fraction and up to 16% in patients with AS. The outcome of patients with AC-TTR remains unknown after TAVI. Thus, the diagnosis of AC-TTR in patients undergoing TAVI represents an important issue. Indeed, a treatment stabilizing the process of accumulation of transthyretin deposits, effective on the survival of these patients, is now available. In addition, a non-invasive screening strategy for AC-TTR, alternative to biopsy, is now validated.
Detailed Description
The aim of the study is to describe prevalence of cardiac amyloidosis with transthyretin in patients undergoing transcatheter aortic valve implantation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Stenosis
Keywords
Cardiac amyloïdosis, aortic stenosis, transthyretine amyloïdosis, CA-TTR, transcatheter aortic valve implantation, TAVI, prevalence, outcome, survival

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
patients undergoing transcatheter aortic valve implantation
Arm Type
Experimental
Arm Description
patients undergoing transcatheter aortic valve implantation for aortic stenosis
Intervention Type
Radiation
Intervention Name(s)
HDP-Tc99m bone scintigraphy
Intervention Description
HDP-Tc99m bone scintigraphy
Primary Outcome Measure Information:
Title
transthyretine cardiac amyloïdosis
Description
Transthyretine cardiac amyloïdosis will be diagnosed using HDP-99mTc bone scintigraphy. The examination will consist of the injection of 10 MBq / kg of 99mTc-labeled biphosphonate, followed by a full-body scan 3 hours post-injection to produce a front thoracic static image and a tomographic image of the thorax. A positive HDP-Tc99m bone scintigraphy will be defined according to the Perugini classification corresponding to stages 2 and 3 (myocardial fixation of intensity equal to or greater than the bone structures).
Time Frame
Hour 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
inclusion criteria : patients over 60 years old Patients admitted in Reims university cardiology department for per-cutaneous aortic valve replacement due to severe aortic stenosis Patients enrolled in the national healthcare insurance program Patients consenting to participate to the study exclusion criteria : - AL amyloïdosis patients
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jérôme COSTA
Phone
03 10 73 63 14
Ext
0033
Email
jcosta@chu-reims.fr
Facility Information:
Facility Name
Damien JOLLY
City
Reims
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jérome COSTA
Phone
03 10 73 63 14
Ext
0033
Email
jcosta@chu-reims.fr

12. IPD Sharing Statement

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Cardiac Amyloidosis Prevalence and Outcome in Aortic Stenosis Patients Undergoing Transcatheter Aortic Valve Implantation

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