Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-26 @ 2:07 AM
Study NCT ID:
NCT05006105
Status:
UNKNOWN
Last Update Posted:
2022-09-16
First Post:
2021-07-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Early Detection of Atrial Fibrillation Using Mobile Technology in Cryptogenic Stroke Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015716', 'term': 'Electrocardiography, Ambulatory'}, {'id': 'D015924', 'term': 'Blood Pressure Monitors'}], 'ancestors': [{'id': 'D004562', 'term': 'Electrocardiography'}, {'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004568', 'term': 'Electrodiagnosis'}, {'id': 'D018670', 'term': 'Monitoring, Ambulatory'}, {'id': 'D008991', 'term': 'Monitoring, Physiologic'}, {'id': 'D019722', 'term': 'Sphygmomanometers'}, {'id': 'D019719', 'term': 'Diagnostic Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER'], 'maskingDescription': 'The participant and care provider are not blinded for which mHealth method is used (smartphone or smartwatch), but are blinded for the mHealth results (i.e., AF detection) during the monitoring period with the mHealth application.'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Group 1 uses PPG-based mHealth with a smartphone; two times a day, a spot-check measurement is taken; and in case of symptoms, additional measurements can be taken.\n\nGroup 2 uses PPG-based mHealth with a smartwatch, this results in semi-continuous measurements that are performed automatically.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 225}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-10-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2025-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-14', 'studyFirstSubmitDate': '2021-07-13', 'studyFirstSubmitQcDate': '2021-08-06', 'lastUpdatePostDateStruct': {'date': '2022-09-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AF detection with mHealth versus ILR - Percentage', 'timeFrame': 'After 6 months of having an ILR inserted and using mHealth.', 'description': 'Percentage of patients with AF detected'}], 'secondaryOutcomes': [{'measure': 'AF detection with ILR - Percentage', 'timeFrame': 'After 12 months of having an ILR inserted.', 'description': 'Percentage of patients with AF detected'}, {'measure': 'AF detection with mHealth versus ILR - Time to first AF detection', 'timeFrame': 'Baseline until end of study (after 12 months of having an ILR inserted).', 'description': 'Time to first AF detection'}, {'measure': 'AF detection with mHealth versus ILR - Frequency', 'timeFrame': 'Baseline until end of study (after 12 months of having an ILR inserted).', 'description': 'Frequency of AF episodes'}, {'measure': 'AF detection with mHealth versus ILR - Duration', 'timeFrame': 'Baseline until end of study (after 12 months of having an ILR inserted).', 'description': 'Duration of AF episodes'}, {'measure': 'User experience and feeling of safety questionnaire', 'timeFrame': 'After 6 months of having an ILR inserted and using mHealth.', 'description': 'Questionnaire with a 7 point Likert scale'}, {'measure': 'Correlation between baseline characteristics and AF detection', 'timeFrame': 'Baseline until end of study (after 12 months of having an ILR inserted).', 'description': 'Baseline characteristics include comorbidities, results of standard of care in-hospital stroke examinations and scores, relevant in-hospital therapy'}, {'measure': 'Correlation between follow-up characteristics and AF detection', 'timeFrame': 'Baseline until end of study (after 12 months of having an ILR inserted).', 'description': 'Follow-up characteristics include changes in therapy, number of relevant readmissions, mortality and healthcare-related costs'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mobile health', 'Prolonged cardiac monitoring', 'Photoplethysmography'], 'conditions': ['Cryptogenic Stroke', 'Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to demonstrate the added value of mobile health (mHealth) to detect atrial fibrillation (AF) early in the care path of cryptogenic stroke and transient ischemic attack (TIA) patients.', 'detailedDescription': 'The use of photoplethysmography (PPG)-based mHealth (with smartphone and smartwatch) is compared to the guideline-recommended insertable loop recorders (ILR) in the detection of AF in cryptogenic stroke or TIA patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of cryptogenic ischemic stroke or TIA\n* The patient or its legal representative is willing to sign the informed consent\n\nExclusion Criteria:\n\n* History of AF or atrial flutter\n* Life expectancy of less than one year\n* Not qualified for ILR insertion\n* Indication or contraindication for permanent oral anticoagulants (OAC) at enrolment\n* Untreated hyperthyroidism\n* Myocardial infarction or coronary bypass grafting less than one month before the stroke onset\n* Presence of patent foramen ovale (PFO) and it is or was an indication to start OAC according to the European Stroke Organization guidelines\n* Inclusion in another clinical trial that will affect the objectives of this study\n* Not able to understand the Dutch language\n* Patient or partner not in possession of a smartphone'}, 'identificationModule': {'nctId': 'NCT05006105', 'acronym': 'REMOTE', 'briefTitle': 'Early Detection of Atrial Fibrillation Using Mobile Technology in Cryptogenic Stroke Patients', 'organization': {'class': 'OTHER', 'fullName': 'Ziekenhuis Oost-Limburg'}, 'officialTitle': 'Early Detection of Atrial Fibrillation Using Mobile Technology in Cryptogenic Stroke Patients - REMOTE Study', 'orgStudyIdInfo': {'id': 'CTU2019106'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PPG-based mHealth on smartphone', 'description': 'Participants used PPG-based mHealth on a smartphone for 6 months. Participants were asked to perform two spot-check measurements and additional measurements in case of symptoms. The use of PPG-based mHealth on a smartphone was initiated on the day of insertable loop recorder insertion.', 'interventionNames': ['Device: seven-day ECG Holter', 'Device: 24-hour blood pressure monitor', 'Other: Questionnaire: vision of mHealth', 'Other: Questionnaire: user experience & feeling of safety', 'Device: Insertable loop recorder']}, {'type': 'EXPERIMENTAL', 'label': 'PPG-based mHealth on smartwatch', 'description': 'Participants used PPG-based mHealth on a smartwatch for 6 months. Participants were asked to wear the smartwatch continuously (except during battery charging). The use of PPG-based mHealth on a smartwatch was initiated on the day of insertable loop recorder insertion.', 'interventionNames': ['Device: seven-day ECG Holter', 'Device: 24-hour blood pressure monitor', 'Other: Questionnaire: vision of mHealth', 'Other: Questionnaire: user experience & feeling of safety', 'Device: Insertable loop recorder']}], 'interventions': [{'name': 'seven-day ECG Holter', 'type': 'DEVICE', 'description': 'Participants receive a seven-day ECG Holter after hospital discharge.', 'armGroupLabels': ['PPG-based mHealth on smartphone', 'PPG-based mHealth on smartwatch']}, {'name': '24-hour blood pressure monitor', 'type': 'DEVICE', 'description': 'Participants receive a 24-hour blood pressure monitor, approximately four weeks after hospital discharge.', 'armGroupLabels': ['PPG-based mHealth on smartphone', 'PPG-based mHealth on smartwatch']}, {'name': 'Questionnaire: vision of mHealth', 'type': 'OTHER', 'description': 'Participants receive a questionnaire concerning their vision of mHealth, approximately four weeks after hospital discharge.', 'armGroupLabels': ['PPG-based mHealth on smartphone', 'PPG-based mHealth on smartwatch']}, {'name': 'Questionnaire: user experience & feeling of safety', 'type': 'OTHER', 'description': 'Participants receive a questionnaire concerning their user experience and feeling of safety of using mHealth, after using mHealth for six months.', 'armGroupLabels': ['PPG-based mHealth on smartphone', 'PPG-based mHealth on smartwatch']}, {'name': 'Insertable loop recorder', 'type': 'DEVICE', 'description': 'Participants receive an insertable loop recorder, approximately six weeks after hospital discharge.', 'armGroupLabels': ['PPG-based mHealth on smartphone', 'PPG-based mHealth on smartwatch']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3600', 'city': 'Genk', 'state': 'Limburg', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'David Verhaert, Dr.', 'role': 'CONTACT', 'email': 'david.verhaert@zol.be'}, {'name': 'Femke Wouters, MSc', 'role': 'CONTACT', 'email': 'femke.wouters@uhasselt.be'}, {'name': 'David Verhaert, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ziekenhuist Oost-Limburg', 'geoPoint': {'lat': 50.965, 'lon': 5.50082}}, {'zip': '3500', 'city': 'Hasselt', 'state': 'Limburg', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Thomas Phlips, Dr.', 'role': 'CONTACT', 'email': 'thomas.phlips@jessazh.be'}, {'name': 'Femke Wouters, MSc', 'role': 'CONTACT', 'email': 'femke.wouters@uhasselt.be'}, {'name': 'Thomas Phlips, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Jessa Hospital', 'geoPoint': {'lat': 50.93106, 'lon': 5.33781}}], 'centralContacts': [{'name': 'David Verhaert, Dr.', 'role': 'CONTACT', 'email': 'david.verhaert@zol.be', 'phone': '+3289 32 70 91'}, {'name': 'Femke Wouters', 'role': 'CONTACT', 'email': 'femke.wouters@zol.be'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ziekenhuis Oost-Limburg', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hasselt University', 'class': 'OTHER'}, {'name': 'Jessa Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'David Verhaert, MD', 'investigatorAffiliation': 'Ziekenhuis Oost-Limburg'}}}}