Ignite Creation Date:
2025-12-24 @ 10:12 PM
Ignite Modification Date:
2026-01-01 @ 5:22 AM
Study NCT ID:
NCT04915235
Status:
RECRUITING
Last Update Posted:
2021-06-07
First Post:
2021-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence and Prognosis of Cardiac Amiloidosis in Turkey
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000465', 'term': 'Algorithms'}], 'ancestors': [{'id': 'D055641', 'term': 'Mathematical Concepts'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2087}, 'targetDuration': '4 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-09-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-05-31', 'studyFirstSubmitDate': '2021-05-31', 'studyFirstSubmitQcDate': '2021-05-31', 'lastUpdatePostDateStruct': {'date': '2021-06-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiac Amyloidosis', 'timeFrame': 'Upon screening', 'description': 'Patients with left ventricular hypertrophy and Cardiac Amyloidosis'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiac Amyloidosis']}, 'descriptionModule': {'briefSummary': 'Patients with left ventricular hypertrophy are further examined according to an algorithm to check if they have a cardiac amyloidosis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with left ventricular hypertrophy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with left ventricular hypertrophy without left ventricular pressure or volume (IVS≥13mm)\n* Patients with left ventricular hypertrophy and hypertension or aortic stenosis without left ventricular pressure or volume (IVS\\>15mm)\n\nExclusion Criteria:\n\n* Patients with left ventricular pressure or volume except the ones with aortic stenosis and arterial hypertension\n* Patients with sigmoid septum and their hypertrophy limited in sigmoid area\n* Patients with highly probable sarcometric hypertrophy cardiomyopathy confirmed with LV morhpology and genetic testing'}, 'identificationModule': {'nctId': 'NCT04915235', 'acronym': 'PAPCAT', 'briefTitle': 'Prevalence and Prognosis of Cardiac Amiloidosis in Turkey', 'organization': {'class': 'OTHER', 'fullName': 'Turkish Society of Cardiology'}, 'officialTitle': 'Prevalence and Prognosis of Cardiac Amiloidosis in Turkey- Registry Study', 'orgStudyIdInfo': {'id': 'PAPCAT'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Algorithm', 'type': 'BEHAVIORAL', 'description': 'Algorithm'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Izmir', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Ebru Ozpelit, MD', 'role': 'CONTACT'}], 'facility': 'Dokuz Eylul University Faculty of Medicine', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}], 'centralContacts': [{'name': 'Ilkay Gucuk, MD', 'role': 'CONTACT', 'email': 'tkd@tkd.org.tr', 'phone': '902122211738'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Turkish Society of Cardiology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}