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| Name | Class |
|---|---|
| Ministry of Health, Malaysia | OTHER_GOV |
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To determine the diagnostic yield of a 30-day smartphone electrocardiogram recording compared to 24-hour Holter monitor for detecting occult paroxysmal atrial fibrillation in patients with a recent ischemic stroke or transient ischemic attack of undetermined etiology after completion of a standard clinical stroke work-up.
Study outcomes
Primary:
Detection of one or more episodes of atrial fibrillation or atrial flutter ≥30 seconds as assessed at the 30 day follow-up.
Secondary:
Exploratory:
To explore the feasibility and cost effectiveness of 30-day smartphone ECG recording for detecting occult paroxysmal atrial fibrillation
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 24 Hour Holter | No Intervention | Patients who are randomised to the 24 Hour Holter monitoring will be contacted within one month from randomisation. The repeat 24 Hour Holter result will be explained to the patient at the end of 30-day follow-up. | |
| Smartphone ECG | Active Comparator | Patients who are randomised to the 30-day smartphone ECG monitoring will be contacted within one month from randomisation. Patients will be taught on how to use the smartphone ECG monitoring. Patients are required to monitor their ECG 3 times a day for 30 days. Patients will be contacted during the monitoring period to assess for compliance and to ensure that the recording is done correctly. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smartphone ECG | Device | Patients who are randomised to the 30-day smartphone ECG monitoring will be contacted within one month from randomisation. Patients will be taught on how to use the smartphone ECG monitoring. Patients are required to monitor their ECG 3 times a day for 30 days. Patients will be contacted during the monitoring period to assess for compliance and to ensure that the recording is done correctly. |
| Measure | Description | Time Frame |
|---|---|---|
| Atrial Fibrillation after 30 days | Detection of one or more episodes of atrial fibrillation or atrial flutter ≥30 seconds as assessed at the 30 day follow-up. This will be reported as number of patient detected to have atrial fibrillation after 30 days. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients prescribed with oral anticoagulation, a assess at the 30-day follow-up | Proportion of patients prescribed with oral anticoagulation, a assess at the 30-day follow-up | 30 days |
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Inclusion Criteria:
i. Age 55 years or older. ii. Diagnosis of the index event made by neurologist or general physician of an acute ischemic stroke or TIA (WHO definition) of undetermined etiology occurring within the previous 6 months (180 days). The event must be either:
iii. Patient meets the following:
iv. The patient is being actively investigated for the etiology of the stroke/TIA event and additional cardiac monitor is desired to screen further for the possibility of AF or atrial flutter.
v. The following diagnostic test have already been completed as part of clinical routine post-stroke/TIA:
vii. The patient is expected to survive at least 12 months.
Exclusion Criteria:
ii. Exclusively retinal stroke or retinal TIA event. iii. A most responsible etiological diagnosis for the qualifying stroke/TIA event has already determined i.e. cervicocephalic artery dissection, venous sinus thrombosis, hypercoagulable states, or other known cause.
iv. Planned carotid endarterectomy within 90 days. v. Any finding on echocardiography for which there is already an evidence-based indication for long-term anticoagulation (e.g. mechanical heart valve, thrombus, etc) vi. Inability to use the AliveCor smartphone ECG monitor upon enrolment into the study (if patient is randomised into interventional group).* vii. Participating in a clinical trial involving investigational medication. viii. Endocarditis. ix. Pregnancy.
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| Name | Affiliation | Role |
|---|---|---|
| Keng Tat Koh, MBBS | Sarawak Heart Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SarawakHC | Kuching | Sarawak | 94300 | Malaysia |
The final decision is depending on the agreement among the co-investigators.
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 4, 2022 | Dec 22, 2022 | 4 |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Multicentre, two-arm, unblinded, randomised controlled trial
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |