Cardiac Amyloidosis
Conditions
Brief summary
Cardiac amyloidosis is an increasingly contributor of degenerative cardiac diseases. However, its frequency remains underestimated, and diagnosis is often realized at late stages of the disease. A larger use of clinical and echographic Red Flag signals during routine echocardiographic examination may enhance the identification of early stage of the disease.
Detailed description
The objective is to evaluate the clinical and epidemiological aspects of cardiac amyloidosis using a systematic screening of even moderate left ventricular hypertrophy, taking into account the presence of Red Flag signals. Red Flag Signals will include history or symptoms of carpal tunnel syndrome, hearing loss, chronic gastrointestinal disorders, heart failure, cervical or lumbar stenosis, or echographic abnormalities such as apical sparring, increased left ventricular filling pressure, atrio-ventricular block.
Interventions
PROCEDUREdiagnostic algorithm
Cardiac amyloidosis diagnosed according to Gillmore's algorithm
Sponsors
Pfizer
University Hospital Center of Martinique
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Diagnosis of left ventricular hypertrophy defined by a parietal thickness (interventricular septum or posterior wall) ≥ 12 mm on the echocardiogram 2. Age equal or greater than 45 years 3. Current residency in Martinique, Guadeloupe or French Guyana 4. Ability to receive and understand research information 5. Ability to freely deliver informed written consent
Exclusion criteria
1. Pregnant or breastfeeding woman 2. Severe uncontrolled hypertension 3. Chronic hemodialysis 4. Person under legal protection measures (guardianship, curatorship, safeguard of justice), and person deprived of liberty
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of cardiac amyloidosis diagnosed according to Gillmore's algorithm | 3 months | frequency of cardiac amyloidosis diagnosed according to Gillmore's algorithm at the end of the diagnosis procedures, using biological (presence of cell dyscrasia), imaging (myocardial staining of bone tracers), and tissue examination (Congo Red staining) variables |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency genotype of Transthyretin cardiac amyloidosis according to Gillmore's algorithm | 5 months | Evaluate the frequency of Transthyretin cardiac amyloidosis among subjects with even moderate left ventricular enlargement (wall thickness ≥ 12 mm), taking into account the presence or not of Red Flag signals |
| Distribution of Red Flag signals according to Transthyretin genotype | 5 months | To Compare the distribution of Red Flag signals between wild type TTR cardiac amyloidosis and hereditary TTR cardiac amyloidosis |
| Diagnosis value of any Red Flag signal. | 5 months | To evaluate the diagnostic performance of each of the Red Flag signals for the diagnosis of TTR cardiac amyloidosis |
| Elaboration of a pre-test probability score | 5 months | To elaborate a pre-test probability score including the Red Flag signals, adapted to the Echo Lab settings. |
Countries
Guadeloupe, Martinique
Contacts
Primary ContactJocelyne CRASPAG, MSc
Backup ContactDoctor INAMO Jocelyn
Outcome results
None listed