Cardiac Amyloidosis : Diagnostic Using Red Flag Signals

NCT04459169

Last updated date
Study Location
Centre Hospitalier de Basse-Terre
Basse-Terre, , 97100, Guadeloupe
Contact
+596596592698

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Cardiac Amyloidosis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
45 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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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Cardiac AmyloidosisCardiac Amyloidosis : Diagnostic Using Red Flag Signals
NCT04459169
  1. Basse-Terre,
  2. Fort-de-France,
  3. La Trinité,
ALL GENDERS
45 Years+
years
MULTIPLE SITES
Advanced Information
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 *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: July 1, 2020)
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:

  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
Sex/Gender
Sexes Eligible for Study:All
Ages 45 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Jocelyne CRASPAG, MSc+596596592698[email protected]
Contact: Doctor INAMO Jocelyn+596596306410[email protected]
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party University Hospital Center of Martinique
Study Sponsor University Hospital Center of Martinique
Collaborators Pfizer
Investigators
Study Director:Doctor INAMO JocelynCHU de Martinique
PRS Account University Hospital Center of Martinique
Verification Date July 2020