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

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ClinicalTrials.gov Identifier: NCT04459169
Recruitment Status : Not yet recruiting
First Posted : July 7, 2020
Last Update Posted : July 7, 2020
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
University Hospital Center of Martinique

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.

Condition or disease Intervention/treatment
Cardiac Amyloidosis Procedure: diagnostic algorithm

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.

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Study Type : Observational
Estimated Enrollment : 424 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Early Echographic Screening of Cardiac Amyloidosis Using Red Flag Signals
Estimated Study Start Date : July 31, 2020
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Amyloidosis


Intervention Details:
  • Procedure: diagnostic algorithm
    Cardiac amyloidosis diagnosed according to Gillmore's algorithm


Primary Outcome Measures :
  1. Frequency of cardiac amyloidosis diagnosed according to Gillmore's algorithm [ Time Frame: 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 Outcome Measures :
  1. Frequency genotype of Transthyretin cardiac amyloidosis according to Gillmore's algorithm [ Time Frame: 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

  2. Distribution of Red Flag signals according to Transthyretin genotype [ Time Frame: 5 months ]
    To Compare the distribution of Red Flag signals between wild type TTR cardiac amyloidosis and hereditary TTR cardiac amyloidosis

  3. Diagnosis value of any Red Flag signal. [ Time Frame: 5 months ]
    To evaluate the diagnostic performance of each of the Red Flag signals for the diagnosis of TTR cardiac amyloidosis

  4. Elaboration of a pre-test probability score [ Time Frame: 5 months ]
    To elaborate a pre-test probability score including the Red Flag signals, adapted to the Echo Lab settings.


Biospecimen Retention:   Samples With DNA
whole blood


Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04459169


Contacts
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Contact: Jocelyne CRASPAG, MSc +596596592698 jocelyne.craspag@chu-martinique.fr
Contact: Doctor INAMO Jocelyn +596596306410 jocelyn.inamo@chu-martinique.fr

Locations
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Guadeloupe
Centre Hospitalier de Basse-Terre
Basse-Terre, Guadeloupe, 97100
Contact: ATALLAH André, MD    +590590805449    atallah.andre@wanadoo.fr   
Principal Investigator: ATALLAH André, MD         
Martinique
CHU de Martinique
Fort-de-France, Martinique, 97261
Contact: Jocelyn INAMO, MD-PhD    +596596306422    jocelyn.inamo@chu-martinique.fr   
CHU de Martinique
La Trinité, Martinique, 97220
Sponsors and Collaborators
University Hospital Center of Martinique
Pfizer
Investigators
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Study Director: Doctor INAMO Jocelyn CHU de Martinique
Additional Information:
Publications:
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Responsible Party: University Hospital Center of Martinique
ClinicalTrials.gov Identifier: NCT04459169    
Other Study ID Numbers: 18_RIPH2-22
First Posted: July 7, 2020    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Amyloidosis
Proteostasis Deficiencies
Metabolic Diseases