Investigation of the use of a radioactive dye in the diagnosis of a build-up of protein deposits within the heart
Phase 1
- Conditions
- Cardiac amyloidosisMedDRA version: 20.0Level: PTClassification code 10007509Term: Cardiac amyloidosisSystem Organ Class: 10007541 - Cardiac disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2020-004627-16-FI
- Lead Sponsor
- Helsinki University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 43
Inclusion Criteria
Known diagnosis of cardiac amyloidosis or previously excluded cardiac amyloidosis (myocardial biopsy or non-invasive imaging).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40
Exclusion Criteria
Pregnancy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: In this study we evaluate the diagnostic use of flutemetamol (Vizamyl) radioactive positron emission tomography (PET) imaging agent in the detection of cardiac amyloid disease. Vizamyl is a derivate of Thioflavin-T which is used for dying amyloid proteins for microscopy. Vizamyl is accepted for clinical use in the imaging of amyloid deposits of the brain;Secondary Objective: We evaluate the possibility of noninvasive detection of different subclasses of amyloid diseases by PET imaging of signal intensity of Vizamyl;Primary end point(s): Total mortality;Timepoint(s) of evaluation of this end point: 1,3 and 5 years
- Secondary Outcome Measures
Name Time Method Secondary end point(s): New diagnosis of heart failure<br>Heart failure hospitalization;Timepoint(s) of evaluation of this end point: 1,3 and 5 years