Ignite Creation Date:
2025-12-25 @ 4:30 AM
Ignite Modification Date:
2026-03-02 @ 7:44 AM
Study NCT ID:
NCT05661318
Status:
RECRUITING
Last Update Posted:
2024-05-29
First Post:
2022-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AHC Ballana Heart Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020022', 'term': 'Genetic Predisposition to Disease'}], 'ancestors': [{'id': 'D004198', 'term': 'Disease Susceptibility'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018570', 'term': 'Risk Assessment'}], 'ancestors': [{'id': 'D012306', 'term': 'Risk'}, {'id': 'D011336', 'term': 'Probability'}, {'id': 'D013223', 'term': 'Statistics as Topic'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012308', 'term': 'Risk Management'}, {'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D015991', 'term': 'Epidemiologic Measurements'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood for laboratory work up \\& whole genome sequencing.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5000}, 'targetDuration': '30 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2055-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-24', 'studyFirstSubmitDate': '2022-12-14', 'studyFirstSubmitQcDate': '2022-12-14', 'lastUpdatePostDateStruct': {'date': '2024-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2050-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiovascular risk assessment', 'timeFrame': '30 years'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['genetics', 'Cardiovascular risks'], 'conditions': ['Genetic Predisposition to Disease']}, 'referencesModule': {'references': [{'pmid': '28230175', 'type': 'BACKGROUND', 'citation': 'Keates AK, Mocumbi AO, Ntsekhe M, Sliwa K, Stewart S. Cardiovascular disease in Africa: epidemiological profile and challenges. Nat Rev Cardiol. 2017 May;14(5):273-293. doi: 10.1038/nrcardio.2017.19. Epub 2017 Feb 23.'}]}, 'descriptionModule': {'briefSummary': 'This Study is designed to assess CVD incidence, prevalence, progression and related risk factors, including genetic background. It will provide an important base for all cardiovascular research activities in our centre and help in designing future studies and guide policy.', 'detailedDescription': 'Background Population-based longitudinal studies are a cornerstone in understanding current disease landscapes affecting communities and collecting reliable data to guide prevention and treatment strategies. In Egypt there is pressing need of collecting reliable data on cardiovascular disease (CVD) in defined populations.\n\nObjectives Defining the cardiovascular phenotype, genotype as well as OMICS and risk factors for CVD in a defined population in Egypt with follow up for up to 30 years\n\nMethods As a first step, a random representative sample of 1,200 households from the Ballana population will be created. Following inclusion, patients will be screened for their cardiovascular profile and followed up for changes in their profile and cardiovascular events continuously every year in high risk patients and every 3 years for the rest of the participants for a period of 30 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '• Residents of Ballana from the 1,200 randomly selected households', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Residents of Ballana from the 1,200 randomly selected households\n* Participants must have a valid National ID card\n* Written informed consent\n\nExclusion criteria:\n\n• Residents who are younger than 18 years'}, 'identificationModule': {'nctId': 'NCT05661318', 'acronym': 'AHC-BHS', 'briefTitle': 'AHC Ballana Heart Study', 'organization': {'class': 'OTHER', 'fullName': 'Magdi Yacoub Heart Foundation'}, 'officialTitle': 'Aswan Heart Centre - Ballana Heart Study', 'orgStudyIdInfo': {'id': 'AHC-BHS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'BHS', 'description': 'Residents of Ballana from the 1,200 randomly selected households', 'interventionNames': ['Other: Risk assessment']}], 'interventions': [{'name': 'Risk assessment', 'type': 'OTHER', 'description': 'Collect clinical, laboratoary and genetics data from the participants after informed consent', 'armGroupLabels': ['BHS']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aswān', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ahmed M ElGuindy, MD, MRCP', 'role': 'CONTACT', 'email': 'ahmed_elguindy@hotmail.com', 'phone': '+201001615151'}, {'name': 'Shehab M Anwer, MD', 'role': 'CONTACT', 'email': 'shehabanwer@gmail.com', 'phone': '+41788816333'}, {'name': 'Magdi H Yacoub, OM FRS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Aswan Heart Centre - Magdi Yacoub Heart Foundation', 'geoPoint': {'lat': 24.09082, 'lon': 32.89942}}], 'centralContacts': [{'name': 'Yasmine Aguib, PhD', 'role': 'CONTACT', 'email': 'yasmine.aguib@aswanheartcentre.com', 'phone': '+201092036368'}, {'name': 'Ahmed Elguindy, MD', 'role': 'CONTACT', 'email': 'ahmed.elguindy@aswanheartcentre.com', 'phone': '+201001615151'}], 'overallOfficials': [{'name': 'Magdi H Yacoub, FRS OM', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Imperial College London, and Magdi Yacoub Heart Foundation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Magdi Yacoub Heart Foundation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}