Stroke Clinical Trial
— PROVE-AFOfficial title:
Prolonged Cardiac Patch Ambulatory Electrocardiogram Versus Conventional Holter Recording For Detection of Atrial Fibrillation After Cerebral Ischemic Event: A Comparative Analysis
Verified date | June 2024 |
Source | Sarawak General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The aim of this study is to compare the diagnostic yield of water-resistant, wireless 7-day cardiac ECG patch versus conventional 24-hour Holter recording in detecting paroxysmal atrial fibrillation in patients admitted with acute ischemic stroke or transient ischemic attack of undetermined etiology after completion of a standard clinical stroke workup.
Status | Active, not recruiting |
Enrollment | 320 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Age =18 years. 2. Diagnosis of acute ischemic stroke or transient ischemic attack (TIA) (WHO definition) of undetermined etiology made by neurologist within 7 days after the index event. The event must be either: - an ischemic stroke confirmed by neuroimaging; or - a TIA, defined as involving a focal unilateral motor deficit, speech/language deficit or hemianopia, with symptom duration <24 hours (note: amaurosis fugax/ transient monocular blindness, pure sensory spells, isolated vertigo spells, etc. do not qualify for enrolment given the potential for misdiagnosis of such events). 3. No AF detected in baseline 12-lead ECG on admission. 4. The following diagnostic test have already been completed as part of clinical routine post-stroke/TIA: - Brain imaging with CT or MRI, - Transthoracic echocardiography to congenital heart disease and endocarditis. 5. Recurrent stroke/TIA is inclusionary as long as patient meets inclusion/exclusion criteria for study enrolment. Exclusion Criteria: 1. Stroke of unknown time of symptom onset. 2. Modified Rankin Scale =5 on index admission. 3. Previous documented history of primary intracerebral bleeding. 4. Previous documented history of AF or atrial flutter (a remote history of transient AF during perioperative period is not exclusionary). 5. Skin allergies, conditions, or sensitivities to cardiac patch. 6. Exclusively retinal stroke or retinal TIA event. 7. Pre-existing indication for anticoagulation (eg. History of mechanical heart valve replacement, deep vein thrombosis). 8. Pre-existing contraindication for permanent anticoagulation (eg. hypocoagulable state). 9. Echocardiographic findings of congenital heart disease and endocarditis. 10. Indicated for pacemaker, implantable cardiac defibrillator (ICD), CRT device, or an implantable hemodynamic monitoring system. 11. Intravenous drug users (IVDUs). 12. Life expectancy < 1 year for reasons other than stroke (eg. Metastatic cancer disease). 13. Concomitant participation in other clinical trials involving investigational medications. 14. Pregnancy. |
Country | Name | City | State |
---|---|---|---|
Malaysia | Sarawak General Hospital | Kuching | Sarawak |
Lead Sponsor | Collaborator |
---|---|
Sarawak General Hospital | Ministry of Health, Malaysia, Sarawak Heart Centre |
Malaysia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Predictors of occult AF. | To identify predictors of occult AF based on clinical, neuroimaging, echocardiography and Holter monitoring results. | 1 month | |
Primary | Detection of newly diagnosed AF or atrial flutter within 24 hours of monitoring with cardiac ECG patch compared to conventional Holter. | Detection of newly diagnosed AF or atrial flutter within 24 hours of monitoring with cardiac ECG patch compared to conventional Holter. | 24 hours | |
Secondary | Detection of AF or atrial flutter within 7 days of monitoring. | Detection of one or more episodes of AF or atrial flutter as assessed after 7 days of Holter monitoring. | 7 days | |
Secondary | Proportion of stroke patients anticoagulated during follow-up. | Proportion of patients prescribed with OAC as assessed at 3 month follow-up. | 3 months | |
Secondary | Rate of stroke recurrent, major adverse bleeding events and detection of AF outside the study protocol. | One year rate of recurrent ischemic stroke or TIA, hemorrhagic stroke, major adverse bleeding events and detection of AF outside the study protocol. | 1 year | |
Secondary | Time to first detection of AF or atrial flutter. | Time to first detection of AF or atrial flutter within 7 days of Holter monitoring. | 7 days | |
Secondary | Health Outcomes. | Health outcome as evaluated by Eq-5D Questionnaire. | 1 year |
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