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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
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
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| Descriptive Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Brief Title | Cardiac Amyloidosis : Diagnostic Using Red Flag Signals | ||||||||
| Official Title | Early Echographic Screening of Cardiac Amyloidosis Using Red Flag Signals | ||||||||
| 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. | ||||||||
| Study Type | Observational | ||||||||
| Study Design | Observational Model: Case-Only Time Perspective: Prospective | ||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples With DNA Description: whole blood | ||||||||
| Sampling Method | Probability Sample | ||||||||
| Study Population | Caribbeans who the large share of populations from African origin may be associated with a high prevalence of Transthyretin amyloidosis. In this population, diagnosis procedure will be perform to any patient with Left Ventricular Hypertrophy (LVH) with wall thickness ? 12 mm associated with clinical manifestations (or Red Flag signals | ||||||||
| Condition | Cardiac Amyloidosis | ||||||||
| Intervention | Procedure: diagnostic algorithm
Cardiac amyloidosis diagnosed according to Gillmore's algorithm | ||||||||
| Study Groups/Cohorts | Not Provided | ||||||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||||
| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment | 424 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | December 31, 2021 | ||||||||
| Estimated Primary Completion Date | September 30, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 45 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
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| Listed Location Countries | Guadeloupe, Martinique | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT04459169 | ||||||||
| Other Study ID Numbers | 18_RIPH2-22 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
| ||||||||
| IPD Sharing Statement | Not Provided | ||||||||
| Responsible Party | University Hospital Center of Martinique | ||||||||
| Study Sponsor | University Hospital Center of Martinique | ||||||||
| Collaborators | Pfizer | ||||||||
| Investigators |
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| PRS Account | University Hospital Center of Martinique | ||||||||
| Verification Date | November 2020 | ||||||||