Ignite Creation Date:
2025-12-24 @ 11:07 PM
Ignite Modification Date:
2026-01-04 @ 1:03 PM
Study NCT ID:
NCT04459169
Status:
UNKNOWN
Last Update Posted:
2020-11-17
First Post:
2020-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiac Amyloidosis : Diagnostic Using Red Flag Signals
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D028227', 'term': 'Amyloid Neuropathies, Familial'}], 'ancestors': [{'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D017772', 'term': 'Amyloid Neuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D028226', 'term': 'Amyloidosis, Familial'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D000686', 'term': 'Amyloidosis'}, {'id': 'D057165', 'term': 'Proteostasis Deficiencies'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'whole blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 424}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-11-16', 'studyFirstSubmitDate': '2020-07-01', 'studyFirstSubmitQcDate': '2020-07-01', 'lastUpdatePostDateStruct': {'date': '2020-11-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Frequency of cardiac amyloidosis diagnosed according to Gillmore's algorithm", 'timeFrame': '3 months', 'description': "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"}], 'secondaryOutcomes': [{'measure': "Frequency genotype of Transthyretin cardiac amyloidosis according to Gillmore's algorithm", 'timeFrame': '5 months', 'description': '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'}, {'measure': 'Distribution of Red Flag signals according to Transthyretin genotype', 'timeFrame': '5 months', 'description': 'To Compare the distribution of Red Flag signals between wild type TTR cardiac amyloidosis and hereditary TTR cardiac amyloidosis'}, {'measure': 'Diagnosis value of any Red Flag signal.', 'timeFrame': '5 months', 'description': 'To evaluate the diagnostic performance of each of the Red Flag signals for the diagnosis of TTR cardiac amyloidosis'}, {'measure': 'Elaboration of a pre-test probability score', 'timeFrame': '5 months', 'description': 'To elaborate a pre-test probability score including the Red Flag signals, adapted to the Echo Lab settings.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiac Amyloidosis']}, 'referencesModule': {'references': [{'pmid': '29972757', 'type': 'BACKGROUND', 'citation': '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': '23984729', 'type': 'BACKGROUND', 'citation': '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': '30747298', 'type': 'BACKGROUND', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'https://www.em-consulte.com/article/1192918/article/frequency-of-cardiac-amyloidosis-inpatients-with-u', 'label': 'Frequency of cardiac amyloidosis inpatients with unexplained left ventricular hypertrophy: The Caribbean Amyloidosis Study'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Caribbeans who the large share of populations from African origin may be associated with a high prevalence of Transthyretin amyloidosis.\n\nIn 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', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosis of left ventricular hypertrophy defined by a parietal thickness (interventricular septum or posterior wall) ≥ 12 mm on the echocardiogram\n2. Age equal or greater than 45 years\n3. Current residency in Martinique, Guadeloupe or French Guyana\n4. Ability to receive and understand research information\n5. Ability to freely deliver informed written consent\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding woman\n2. Severe uncontrolled hypertension\n3. Chronic hemodialysis\n4. Person under legal protection measures (guardianship, curatorship, safeguard of justice), and person deprived of liberty'}, 'identificationModule': {'nctId': 'NCT04459169', 'acronym': 'TEAM Red Flags', 'briefTitle': 'Cardiac Amyloidosis : Diagnostic Using Red Flag Signals', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Center of Martinique'}, 'officialTitle': 'Early Echographic Screening of Cardiac Amyloidosis Using Red Flag Signals', 'orgStudyIdInfo': {'id': '18_RIPH2-22'}}, 'armsInterventionsModule': {'interventions': [{'name': 'diagnostic algorithm', 'type': 'PROCEDURE', 'description': "Cardiac amyloidosis diagnosed according to Gillmore's algorithm"}]}, 'contactsLocationsModule': {'locations': [{'zip': '97100', 'city': 'Basse-Terre', 'status': 'NOT_YET_RECRUITING', 'country': 'Guadeloupe', 'contacts': [{'name': 'ATALLAH André, MD', 'role': 'CONTACT', 'email': 'atallah.andre@wanadoo.fr', 'phone': '+590590805449'}, {'name': 'ATALLAH André, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Hospitalier de Basse-Terre', 'geoPoint': {'lat': 15.99714, 'lon': -61.73214}}, {'zip': '97261', 'city': 'Fort-de-France', 'status': 'RECRUITING', 'country': 'Martinique', 'contacts': [{'name': 'Jocelyn INAMO, MD-PhD', 'role': 'CONTACT', 'email': 'jocelyn.inamo@chu-martinique.fr', 'phone': '+596596306422'}], 'facility': 'CHU de Martinique', 'geoPoint': {'lat': 14.60365, 'lon': -61.07418}}, {'zip': '97220', 'city': 'La Trinité', 'status': 'NOT_YET_RECRUITING', 'country': 'Martinique', 'contacts': [{'name': 'Nathalie OZIER-LAFONTAINE, MD', 'role': 'CONTACT', 'email': 'nathalie.ozier-lafontaine@chu-martinique.fr', 'phone': '+596596604846'}, {'name': 'Nathalie OZIER-LAFONTAINE, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de Martinique', 'geoPoint': {'lat': 14.73807, 'lon': -60.96319}}], 'centralContacts': [{'name': 'Jocelyne CRASPAG, MSc', 'role': 'CONTACT', 'email': 'jocelyne.craspag@chu-martinique.fr', 'phone': '+596596592698'}, {'name': 'Doctor INAMO Jocelyn', 'role': 'CONTACT', 'email': 'jocelyn.inamo@chu-martinique.fr', 'phone': '+596596306410'}], 'overallOfficials': [{'name': 'Doctor INAMO Jocelyn', 'role': 'STUDY_DIRECTOR', 'affiliation': 'CHU de Martinique'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Center of Martinique', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}