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Cardiac Amyloidosis : Diagnostic Using Red Flag Signals (TEAM Red Flags)

U

University Hospital Center of Martinique

Status

Unknown

Conditions

Cardiac Amyloidosis

Treatments

Procedure: diagnostic algorithm

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT04459169
18_RIPH2-22

Details and patient eligibility

About

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.

Full 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.

Enrollment

424 estimated patients

Sex

All

Ages

45+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

3

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Central trial contact

Jocelyne CRASPAG, MSc; Doctor INAMO Jocelyn

Data sourced from clinicaltrials.gov

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