Ignite Creation Date:
2025-12-24 @ 4:35 PM
Ignite Modification Date:
2025-12-27 @ 1:34 PM
Study NCT ID:
NCT05784766
Status:
UNKNOWN
Last Update Posted:
2023-11-22
First Post:
2023-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Screening for Atrial Fibrillation in Patients With Cancer: A Pilot Randomized Controlled Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 480}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2025-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-20', 'studyFirstSubmitDate': '2023-02-27', 'studyFirstSubmitQcDate': '2023-03-13', 'lastUpdatePostDateStruct': {'date': '2023-11-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Investigators will compare the incidence of newly diagnosed AF identified by screening versus usual care', 'timeFrame': '6 MONTHS', 'description': 'To compare the incidence of newly diagnosed AF with point-of-care screening using a mobile, single-lead ECG versus usual care, in patients with a diagnosis of solid cancer. In this open-label, prospective pilot RCT, patients (n=480) with AF and solid cancer presenting for an outpatient visit will be randomized 1:1 to screening versus usual care. A 30-second screening ECG will be done using the Kardia Mobile device (AliveCor Inc, Cupertino, CA) paired with an iPad. The Investigators will compare the incidence of newly diagnosed AF identified by screening versus usual care.'}], 'secondaryOutcomes': [{'measure': 'To determine the effect of screening-detected AF on initiation of anticoagulation.', 'timeFrame': '6 MONTHS', 'description': 'To determine the effect of screening-detected AF on initiation of anticoagulation. Patients diagnosed with AF through screening will be referred to their primary care physician for initiation of anticoagulation based on their CHA2DS2VASc score.The Investigators will conduct chart review at the end of study to compare the proportion of patients appropriately initiated on anticoagulation between screening versus usual care.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Cancer']}, 'descriptionModule': {'briefSummary': 'Patients with cancer have a higher incidence of AF but despite the higher incidence of AF in the cancer population, there are no randomized controlled trials (RCTs) for AF screening in this population. RCTs of AF screening in the general population have shown that screening can effectively detect AF earlier, and helps to identify candidates for appropriate anticoagulation that may lead to improvement in clinical outcomes.', 'detailedDescription': 'The Investigators will conduct an open label, prospective, pilot RCT. After informed consent, patients will be randomized 1:1 into screening or usual care. Screening will be done at a single time point. Patients randomized to screening will undergo a 30-second ECG using the Kardia Mobile device (AliveCor Inc, Cupertino, CA) paired with an iPad (Apple, Cupertino, CA). Patients randomized to usual care will not receive a screening ECG. Primary outcome will be detection of newly diagnosed AF by screening vs usual care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male and female patients age ≥65 with a current diagnosis or history of cancer.\n2. Patients currently undergoing or history of chemotherapy, radiotherapy or cancer related surgeries will be included.\n3. The age is restricted to ≥65 years because prevalence of AF is extremely low. .\n\nExclusion Criteria:\n\n1. Known history of atrial fibrillation.\n2. Non-English-speaking participants will not be enrolled'}, 'identificationModule': {'nctId': 'NCT05784766', 'acronym': 'SARIC', 'briefTitle': 'Screening for Atrial Fibrillation in Patients With Cancer: A Pilot Randomized Controlled Clinical Trial', 'organization': {'class': 'OTHER', 'fullName': 'University of Oklahoma'}, 'officialTitle': 'Screening for Atrial Fibrillation in Patients With Cancer: A Pilot Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': '15595'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Screen group', 'description': 'Patients randomized to screening will undergo a 30-second ECG using the Kardia Mobile device (AliveCor Inc, Cupertino, CA) paired with an iPad (Apple, Cupertino, CA). If the mobile ECG shows possible AF or unclassified, then patients will undergo a 12-lead standard ECG during the same visit, read by a cardiologist, to verify the correct diagnosis.', 'interventionNames': ['Diagnostic Test: 30-second ECG using the Kardia Mobile']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual Care', 'description': 'For patients in the usual care arm, medical record review will be done at end of study to assess for the newly diagnosed AF during the study period.', 'interventionNames': ['Other: routine care']}], 'interventions': [{'name': '30-second ECG using the Kardia Mobile', 'type': 'DIAGNOSTIC_TEST', 'description': '30-second ECG using the Kardia Mobile', 'armGroupLabels': ['Screen group']}, {'name': 'routine care', 'type': 'OTHER', 'description': 'medical review', 'armGroupLabels': ['Usual Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Aurora Vera', 'role': 'CONTACT', 'phone': '405-271-9060', 'phoneExt': '45319'}, {'name': 'Natalia Serrano', 'role': 'CONTACT', 'phone': '405-271-9060', 'phoneExt': '37520'}], 'facility': 'University of Oklahoma Health Sciences Center', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}], 'centralContacts': [{'name': 'Aurora Vera, RMA', 'role': 'CONTACT', 'email': 'Aurora-vera@ouhsc.edu', 'phone': '405-271-9060', 'phoneExt': '45319'}, {'name': 'Zain Asad, MD', 'role': 'CONTACT', 'email': 'ZainUlAbideen.Asad@ouhealth.com', 'phone': '405-271-4742'}], 'overallOfficials': [{'name': 'Zain Asad, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'OU Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oklahoma', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}