Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2025-12-26 @ 2:23 AM
Study NCT ID:
NCT05337202
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-20
First Post:
2022-04-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
the Dutch-GERAF Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D000073496', 'term': 'Frailty'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-09-01', 'size': 359924, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-04-13T08:32', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Full blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1075}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-01-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-19', 'studyFirstSubmitDate': '2022-04-13', 'studyFirstSubmitQcDate': '2022-04-13', 'lastUpdatePostDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Newly identified cases of atrial fibrillation', 'timeFrame': 'The first 6 months after recruitment for the study', 'description': 'PPG or ECG detected new cases of atrial fibrillation'}], 'secondaryOutcomes': [{'measure': 'Major bleeding', 'timeFrame': 'From recruitment until 3 years after the recruitment of the last participant', 'description': 'Major bleeding, including intra cranial haemorrhage'}, {'measure': 'Stroke', 'timeFrame': 'From recruitment until 3 years after the recruitment of the last participant', 'description': 'Stroke'}, {'measure': 'Death', 'timeFrame': 'From recruitment until 3 years after the recruitment of the last participant', 'description': 'Death'}, {'measure': 'Cognitive disorder', 'timeFrame': 'From recruitment until 3 years after the recruitment of the last participant', 'description': 'Development of dementia, categorized by aetiology, during follow up'}, {'measure': 'New Atrial Fibrillation, developed after the screening period', 'timeFrame': 'From recruitment until 3 years after the recruitment of the last participant', 'description': 'New Atrial Fibrillation, developed after the screening period'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Atrial Fibrillation', 'Frailty', 'Major Bleed', 'Intra cranial Haemorrhage', 'Cognitive disorder', 'eHealth'], 'conditions': ['Atrial Fibrillation', 'Frailty', 'Major Bleed']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Zwart LAR, Germans T, Simsek S, Ruiter JH, Jansen RWMM. Atrial fibrillation, anticoagulation and major bleeding in geriatric patients at risk of falling. OBM Geriatrics 2019, Volume 3, Issue 3, doi:10.21926/obm.geriatr.1903071'}, {'pmid': '35265881', 'type': 'BACKGROUND', 'citation': 'Mol D, Riezebos RK, Marquering HA, Werner ME, Lobban TCA, de Jong JSSG, de Groot JR. Performance of an automated photoplethysmography-based artificial intelligence algorithm to detect atrial fibrillation. Cardiovasc Digit Health J. 2020 Oct 22;1(2):107-110. doi: 10.1016/j.cvdhj.2020.08.004. eCollection 2020 Sep-Oct. No abstract available.'}, {'pmid': '32860505', 'type': 'RESULT', 'citation': 'Hindricks G, Potpara T, Dagres N, Arbelo E, Bax JJ, Blomstrom-Lundqvist C, Boriani G, Castella M, Dan GA, Dilaveris PE, Fauchier L, Filippatos G, Kalman JM, La Meir M, Lane DA, Lebeau JP, Lettino M, Lip GYH, Pinto FJ, Thomas GN, Valgimigli M, Van Gelder IC, Van Putte BP, Watkins CL; ESC Scientific Document Group. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS): The Task Force for the diagnosis and management of atrial fibrillation of the European Society of Cardiology (ESC) Developed with the special contribution of the European Heart Rhythm Association (EHRA) of the ESC. Eur Heart J. 2021 Feb 1;42(5):373-498. doi: 10.1093/eurheartj/ehaa612. No abstract available.'}, {'pmid': '32280331', 'type': 'RESULT', 'citation': 'Zwart LA, Jansen RW, Ruiter JH, Germans T, Simsek S, Hemels ME. Opportunistic screening for atrial fibrillation with a single lead device in geriatric patients. J Geriatr Cardiol. 2020 Mar;17(3):149-154. doi: 10.11909/j.issn.1671-5411.2020.03.007.'}, {'pmid': '18826625', 'type': 'RESULT', 'citation': 'Searle SD, Mitnitski A, Gahbauer EA, Gill TM, Rockwood K. A standard procedure for creating a frailty index. BMC Geriatr. 2008 Sep 30;8:24. doi: 10.1186/1471-2318-8-24.'}, {'pmid': '17634318', 'type': 'RESULT', 'citation': 'Rockwood K, Mitnitski A. Frailty in relation to the accumulation of deficits. J Gerontol A Biol Sci Med Sci. 2007 Jul;62(7):722-7. doi: 10.1093/gerona/62.7.722.'}, {'pmid': '29890749', 'type': 'RESULT', 'citation': 'Moraes JL, Rocha MX, Vasconcelos GG, Vasconcelos Filho JE, de Albuquerque VHC, Alexandria AR. Advances in Photopletysmography Signal Analysis for Biomedical Applications. Sensors (Basel). 2018 Jun 9;18(6):1894. doi: 10.3390/s18061894.'}, {'pmid': '38619715', 'type': 'DERIVED', 'citation': 'Dutch-GERAF investigators; Zwart LAR, Spruit JR, Hemels MEW, de Groot JR, Pisters R, Riezebos RK, Jansen RWMM. Design of the Dutch multicentre study on opportunistic screening of geriatric patients for atrial fibrillation using a smartphone PPG app: the Dutch-GERAF study. Neth Heart J. 2024 May;32(5):200-205. doi: 10.1007/s12471-024-01868-6. Epub 2024 Apr 15.'}]}, 'descriptionModule': {'briefSummary': 'Geriatric patients are at high risk of cardiovascular complications, and for the development of atrial fibrillation. Often atrial fibrillation exists in these patients without specific symptoms, and could therefore remain unknown. Furthermore, concerns exist about the bleeding profile of anticoagulation in the very elderly or frail patients.\n\nThis study applies opportunistic screening for atrial fibrillation as advised in the latest ESC Guideline on the diagnosis and management of atrial fibrillation. Furthermore, multiple bleeding risk scores will be applies, to better assess the bleeding risk in very elderly or frail patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All newly referred patients of 65 years and older that visit a geriatric outpatient service. These will form a cohort of very elderly individuals, with multi morbidity, polypharmacy, cognitive disorders, high frailty and high risk for falling. They can also be seen as a group at high risk of cardiovascular complication and/or the development of cognitive disorders.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll newly referred patients of 65 years and older that visit geriatric outpatient services are eligible (including Fall clinic, Memory clinic, Pre-operative geriatric assessment clinic, or any other geriatric outpatient clinics that are led by a geriatrician).\n\nExclusion Criteria:\n\n* The patient has a pacemaker or implantable cardioverter defibrillator.\n* The patient is known with a severe dementia, MoCA ≤ 15 points.\n* The patient has a severe tremor, from whatever cause, and thus is unable to use the PPG based smartphone AF detection algorithm.'}, 'identificationModule': {'nctId': 'NCT05337202', 'acronym': 'GERAF', 'briefTitle': 'the Dutch-GERAF Study', 'organization': {'class': 'OTHER', 'fullName': 'Dijklander Ziekenhuis'}, 'officialTitle': 'The Dutch Multicentre Study Into Opportunistically Screening Geriatric Patients for Atrial Fibrillation Using a PPG Smartphone App; the Dutch-GERAF Study', 'orgStudyIdInfo': {'id': 'WB 694'}}, 'armsInterventionsModule': {'interventions': [{'name': 'HeartSDK', 'type': 'DEVICE', 'description': 'The photoplethysmography (PPG) application enables patients to perform a finger tip heartbeat measurement and automatic analysis'}]}, 'contactsLocationsModule': {'locations': [{'zip': '6815 AD', 'city': 'Arnhem', 'state': 'Gelderland', 'country': 'Netherlands', 'facility': 'Rijnstate', 'geoPoint': {'lat': 51.98, 'lon': 5.91111}}, {'zip': '1624NP', 'city': 'Hoorn', 'state': 'North Holland', 'country': 'Netherlands', 'facility': 'Dijklander Ziekenhuis', 'geoPoint': {'lat': 52.6425, 'lon': 5.05972}}, {'zip': '1815 JD', 'city': 'Alkmaar', 'country': 'Netherlands', 'facility': 'Noordwest ziekenhuisgroep', 'geoPoint': {'lat': 52.63167, 'lon': 4.74861}}, {'zip': '3813 TZ', 'city': 'Amersfoort', 'country': 'Netherlands', 'facility': 'Meander Medisch Centrum', 'geoPoint': {'lat': 52.155, 'lon': 5.3875}}, {'zip': '1091 AC', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Onze Lieve Vrouwe Gasthuis', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '3318 AT', 'city': 'Dordrecht', 'country': 'Netherlands', 'facility': 'Albert Schweitzer Ziekenhuis', 'geoPoint': {'lat': 51.81, 'lon': 4.67361}}], 'overallOfficials': [{'name': 'René Jansen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwest Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Upon reasonable request, anonymized data could be shared after approval of all principal investigators'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dijklander Ziekenhuis', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}