Cardiac Amyloidosis : Diagnostic Using Red Flag Signals

NCT04459169 | Unknown

• 1 other identifier: 18_RIPH2-22
• Study Type: observational
• Target: 424
• Locations: 2 countries
• Sites: 3

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.

Conditions

Cardiac Amyloidosis

Outcome Measures

Primary Outcomes (1)

• Frequency of cardiac amyloidosis diagnosed according to Gillmore's algorithm

  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

  3 months

Secondary Outcomes (4)

• Frequency genotype of Transthyretin cardiac amyloidosis according to Gillmore's algorithm

  5 months

• Distribution of Red Flag signals according to Transthyretin genotype

  5 months

• Diagnosis value of any Red Flag signal.

  5 months

• Elaboration of a pre-test probability score

  5 months

Interventions

diagnostic algorithm PROCEDURE

Cardiac amyloidosis diagnosed according to Gillmore's algorithm

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Diagnosis of left ventricular hypertrophy defined by a parietal thickness (interventricular septum or posterior wall) ≥ 12 mm on the echocardiogram
• Age equal or greater than 45 years
• Current residency in Martinique, Guadeloupe or French Guyana
• Ability to receive and understand research information
• Ability to freely deliver informed written consent

You may not qualify if:

• Pregnant or breastfeeding woman
• Severe uncontrolled hypertension
• Chronic hemodialysis
• Person under legal protection measures (guardianship, curatorship, safeguard of justice), and person deprived of liberty

Sponsors & Collaborators

• University Hospital Center of Martinique: lead
• Pfizer: collaborator

Study Sites (3)

Centre Hospitalier de Basse-Terre

Basse-Terre, 97100, Guadeloupe

NOT YET RECRUITING

CHU de Martinique

Fort-de-France, 97261, Martinique

RECRUITING

CHU de Martinique

La Trinité, 97220, Martinique

NOT YET RECRUITING

Related Publications (3)

• Benson MD, Waddington-Cruz M, Berk JL, Polydefkis M, Dyck PJ, Wang AK, Plante-Bordeneuve V, Barroso FA, Merlini G, Obici L, Scheinberg M, Brannagan TH 3rd, Litchy WJ, Whelan C, Drachman BM, Adams D, Heitner SB, Conceicao I, Schmidt HH, Vita G, Campistol JM, Gamez J, Gorevic PD, Gane E, Shah AM, Solomon SD, Monia BP, Hughes SG, Kwoh TJ, McEvoy BW, Jung SW, Baker BF, Ackermann EJ, Gertz MA, Coelho T. Inotersen Treatment for Patients with Hereditary Transthyretin Amyloidosis. N Engl J Med. 2018 Jul 5;379(1):22-31. doi: 10.1056/NEJMoa1716793.

  PMID: 29972757 BACKGROUND

• Coelho T, Adams D, Silva A, Lozeron P, Hawkins PN, Mant T, Perez J, Chiesa J, Warrington S, Tranter E, Munisamy M, Falzone R, Harrop J, Cehelsky J, Bettencourt BR, Geissler M, Butler JS, Sehgal A, Meyers RE, Chen Q, Borland T, Hutabarat RM, Clausen VA, Alvarez R, Fitzgerald K, Gamba-Vitalo C, Nochur SV, Vaishnaw AK, Sah DW, Gollob JA, Suhr OB. Safety and efficacy of RNAi therapy for transthyretin amyloidosis. N Engl J Med. 2013 Aug 29;369(9):819-29. doi: 10.1056/NEJMoa1208760.

  PMID: 23984729 BACKGROUND

• Di Nunzio D, Recupero A, de Gregorio C, Zito C, Carerj S, Di Bella G. Echocardiographic Findings in Cardiac Amyloidosis: Inside Two-Dimensional, Doppler, and Strain Imaging. Curr Cardiol Rep. 2019 Feb 12;21(2):7. doi: 10.1007/s11886-019-1094-z.

  PMID: 30747298 BACKGROUND

Related Links

• Frequency of cardiac amyloidosis inpatients with unexplained left ventricular hypertrophy: The Caribbean Amyloidosis Study

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

MeSH Terms

Conditions

Amyloid Neuropathies, Familial

Condition Hierarchy (Ancestors)

Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Nervous System Diseases; Amyloid Neuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Amyloidosis, Familial; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases; Amyloidosis; Proteostasis Deficiencies

Study Officials

• Doctor INAMO Jocelyn

  CHU de Martinique

  STUDY DIRECTOR

Central Study Contacts

Jocelyne CRASPAG, MSc

CONTACT

+596596592698; jocelyne.craspag@chu-martinique.fr

Doctor INAMO Jocelyn

CONTACT

+596596306410; jocelyn.inamo@chu-martinique.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2020
• First Posted: July 7, 2020
• Study Start: September 30, 2020
• Primary Completion: September 30, 2021
• Study Completion: December 31, 2021
• Last Updated: November 17, 2020

Record last verified: 2020-11

Locations

GU (1); MA (2)