Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2026-03-03 @ 2:26 PM
Study NCT ID:
NCT03710902
Status:
RECRUITING
Last Update Posted:
2025-03-20
First Post:
2018-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Empowerment and Mobile Technology in the Control of Cardiovascular Risk Factors in Patients With Ischemic Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D002546', 'term': 'Ischemic Attack, Transient'}, {'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D000079102', 'term': 'Empowerment'}], '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': 'D002545', 'term': 'Brain Ischemia'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Clinical endpoints will be assessed according to PROBE principles, i.e. outcomes assessors are masked to treatment allocation.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 405}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-10-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2028-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-18', 'studyFirstSubmitDate': '2018-10-16', 'studyFirstSubmitQcDate': '2018-10-17', 'lastUpdatePostDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Rate of Adverse Events', 'timeFrame': '12 months', 'description': 'Adverse events related to ECG monitoring, blood pressure home monitoring, and mobile-device assisted self-adjustment of blood pressure medication according to a pre-specified protocol.'}, {'measure': 'Rate of Severe Adverse Events', 'timeFrame': '12 months', 'description': 'Severe adverse event related to mobile-device assisted self-adjustment of blood pressure medication according to a pre-specified protocol.'}], 'primaryOutcomes': [{'measure': 'Number of Participants with New Atrial fibrillation', 'timeFrame': '12 months', 'description': 'New diagnosis of atrial fibrillation (\\>30 s)'}, {'measure': 'Change in Blood Pressure', 'timeFrame': '12 months', 'description': 'Mean change in systolic/diastolic blood pressure'}], 'secondaryOutcomes': [{'measure': 'Number of Participants with New Cardiovascular Events within 12 Months', 'timeFrame': '12 months', 'description': 'Any of stroke, myocardial infarction, revascularization, or cardiovascular death'}, {'measure': 'Number of Participants with New Cardiovascular Events within 36 Months', 'timeFrame': '36 months', 'description': 'Any of stroke, myocardial infarction, revascularization, or cardiovascular death'}, {'measure': 'Health Care Costs', 'timeFrame': '36 months', 'description': 'Total direct healthcare costs'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ischemic Stroke', 'Transient Ischemic Attack', 'Atrial Fibrillation', 'Hypertension', 'Empowerment']}, 'referencesModule': {'references': [{'pmid': '40082922', 'type': 'DERIVED', 'citation': 'Lumikari T, Putaala J, Pirinen J, Kerola A, Sibolt G, Granroth-Wilding H, Pakarinen S, Lehto M, Nieminen T. Empowerment and mobile technology in the detection and treatment of main cardiovascular risk factors of patients with ischemic stroke or transient ischemic attack: a protocol for a multicenter randomized controlled trial (CARDIOSTROKE). Trials. 2025 Mar 14;26(1):89. doi: 10.1186/s13063-025-08778-x.'}]}, 'descriptionModule': {'briefSummary': 'The CARDIOSTROKE is a randomized trial comparing mobile-device assisted control of hypertension together with screening of occult atrial fibrillation to standard care in patients with recent ischemic stroke or transient ischemic attack.', 'detailedDescription': 'Atrial fibrillation (AF) and hypertension are among the main treatable risk factors for ischemic stroke and transient ischemic attack (TIA). Detecting paroxysmal atrial fibrillation in stroke patients is challenging, but highly relevant since anticoagulation can effectively reduce the risk of recurrent strokes. Furthermore, hypertension remains poorly controlled even after stroke despite multiple available treatment options. In the CARDIOSTROKE trial, the investigators aim to randomize 405 patients with recent ischemic stroke or TIA into (1) standard diagnostic work-up, follow-up and treatment (control group) and (2) 3-week ECG monitoring to detect occult AF and self-monitoring of blood pressure with mobile-device-assisted self-titration of antihypertensive medication (intervention group). Randomization will occur 2:1 into control and intervention groups. The co-primary outcomes include (1) incidence of new-onset AF and (2) difference in the mean blood pressure at 12-months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ischemic stroke or transient ischemic attack (ABCD2 score ≥3)\n* Age ≥40 years\n* Pre-existing or newly diagnosed hypertension\n* Informed consent from the patient or legal representative\n\nExclusion Criteria:\n\n* Known high-risk source of cardioembolism\n* Known indication for anticoagulation\n* Contraindication for anticoagulation\n* Pacemaker\n* Non-compliance to study interventions as judged by the investigator\n* Serious condition hampering the study conduct'}, 'identificationModule': {'nctId': 'NCT03710902', 'acronym': 'CARDIOSTROKE', 'briefTitle': 'Empowerment and Mobile Technology in the Control of Cardiovascular Risk Factors in Patients With Ischemic Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Hospital District of Helsinki and Uusimaa'}, 'officialTitle': 'Empowerment and Mobile Technology in the Control of Cardiovascular Risk Factors in Patients With Ischemic Stroke', 'orgStudyIdInfo': {'id': 'HUS/53/2017'}, 'secondaryIdInfos': [{'id': 'TYH2016127', 'type': 'OTHER_GRANT', 'domain': 'Hospital District of Helsinki and Uusimaa'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'interventionNames': ['Diagnostic Test: ECG monitoring for 3 weeks', 'Other: Self-monitoring of BP and self-titration of antihypertensive medication']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Standard diagnostic work-up, follow-up, and treatment of hypertension.'}], 'interventions': [{'name': 'ECG monitoring for 3 weeks', 'type': 'DIAGNOSTIC_TEST', 'description': 'A 3-week continuous ECG monitoring to detect occult AF.', 'armGroupLabels': ['Intervention']}, {'name': 'Self-monitoring of BP and self-titration of antihypertensive medication', 'type': 'OTHER', 'description': 'One-week monthly self-monitoring of BP and self-titration of antihypertensive medication according to a pre-specified protocol, assisted with a mobile device application.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hämeenlinna', 'status': 'RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Tiina Alapirtti, MD, PhD', 'role': 'CONTACT', 'email': 'tiina.alapirtti@khshp.fi'}, {'name': 'Elina Laakso, MD', 'role': 'CONTACT', 'email': 'elina.laakso@khshp.fi'}], 'facility': 'Kanta-Häme Central Hospital', 'geoPoint': {'lat': 60.99596, 'lon': 24.46434}}, {'zip': '00290', 'city': 'Helsinki', 'status': 'RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Terhi Saarikoski, RN', 'role': 'CONTACT', 'email': 'terhi.saarikoski@hus.fi', 'phone': '+35894711'}, {'name': 'Tuomo Nieminen, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jukka Putaala, A/Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Tuomas Lumikari, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Helsinki University Hospital', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'city': 'Hyvinkää', 'status': 'RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Terttu Heinkinheimo-Connell, MD, PhD', 'role': 'CONTACT', 'email': 'terttu.heikinheimo-connell@hus.fi'}, {'name': 'Katariina Hirvonen, MD', 'role': 'CONTACT', 'email': 'katariina.hirvonen@hus.fi'}], 'facility': 'Hyvinkää Hospital', 'geoPoint': {'lat': 60.63333, 'lon': 24.86667}}, {'city': 'Lahti', 'status': 'RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Tuomo Nieminen, MD, PhD, Prof.', 'role': 'CONTACT', 'email': 'tuomo.nieminen@gmail.com'}, {'name': 'Anne Kerola, MD, PhD', 'role': 'CONTACT', 'email': 'anne.m.kerola@phhyky.fi'}], 'facility': 'Päijät-Häme Central Hospital', 'geoPoint': {'lat': 60.98267, 'lon': 25.66151}}], 'centralContacts': [{'name': 'Tuomas Lumikari, MD', 'role': 'CONTACT', 'email': 'tuomas.lumikari@helsinki.fi', 'phone': '+35894711'}, {'name': 'Anu Eräkanto', 'role': 'CONTACT', 'email': 'anu.erakanto@hus.fi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jukka Putaala', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Head of Stroke Unit', 'investigatorFullName': 'Jukka Putaala', 'investigatorAffiliation': 'Hospital District of Helsinki and Uusimaa'}}}}