StrokeSMART-AFNCT04332718
Smartphone Electrocardiogram for Recording Atrial Fibrillation After a Cerebral Ischemic Event
A study testing Smartphone ECG in people with Stroke and Atrial Fibrillation, run by Sarawak Heart Centre at 1 site in Malaysia.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Stroke, Atrial Fibrillation
- What is being tested?
- Smartphone ECG
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- 1 siteMalaysia
- Study dates
- 15 Nov 2017to 30 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- An ischemic stroke confirmed by neuroimaging; or
- A transient ischemic attack, 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).
- Patient meets the following:
- At least one 12-lead ECG has already been obtained as part of the routine clinical post-stroke/TIA work up, and not ECGs have shown any episodes of AF or atrial flutter.
- A Holter monitor has already been obtained as part of the routine clinical post-stroke/TIA work-up, and does not show any episodes of AF or atrial flutter ≥30seconds.
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- 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.
- The following diagnostic test have already been completed as part of clinical routine post-stroke/TIA:
- Brain imaging with CT or MRI
- Vascular imaging of the extracranial and intracranial circulation with either CT angiography or MRI angiography to exclude significant large vessel occlusion disease as the most likely mechanism for index ischemic event (carotid Doppler ultrasound is acceptable for those presenting with anterior circulation ischemic events).*
- Transthoracic (or transesophageal) echocardiography to exclude thrombus or other structural heart disease that in the opinion of the investigator is the most likely cause for the stroke/TIA events.* *(if a baseline investigation cannot be obtained clinically after the index event and prior to study enrolment, then it is acceptable for study purposes for investigations to be obtained after patient enrolment into the study but prior to the 90-day follow-up visit.) vi. Informed consent from the patient (or from a legally authorised representative if the patient is not competent, due to stroke-related cognitive impairment, aphasia, or anosognosia).
- The patient is expected to survive at least 12 months.
Who cannot join
- i. Any previously documented atrial fibrillation or atrial flutter (a remote history of transient AF during perioperative period is not exclusionary).
- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Smartphone Electrocardiogram for Recording Atrial Fibrillation After a Cerebral Ischemic Event: A Randomised Controlled Trial
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.
Read the detailed description
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:
- Proportion of patients prescribed oral anticoagulation, as assess at the 30-day follow up.
- Patient adherence with 30-day smartphone ECG monitoring, and percentage of patients using the monitor >75% of the target in 30-day period
- Time to first detection of AF within 30 days (days)
- One year rate of recurrent ischemic stroke or transient ischemic attack, death, hemorrhagic stroke, major adverse bleeding events, detection of AF outside the study protocol.
Exploratory:
To explore the feasibility and cost effectiveness of 30-day smartphone ECG recording for detecting occult paroxysmal atrial fibrillation
- Conditions
- Stroke, Atrial Fibrillation
- Being tested
- Smartphone ECG
- Keywords
- Stroke, Atrial Fibrillation, Smartphone ECG
- Medical subject headings
- Stroke, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone ECGDevice
Also called AliveCor
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Smartphone ECG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (1)
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
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2020
- Study start15 Nov 2017
- Primary completion30 Jun 2020
- Study completion30 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicentre, two-arm, unblinded, randomised controlled trial
- Masking
- None (open label)
- Enrolment
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sarawak Heart Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Malaysia
- Responsible party
- Principal investigator, Dr. Koh Keng Tat, Sarawak Heart Centre
- Investigators
- Keng Tat Koh, MBBS, Principal investigator, Sarawak Heart Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04332718
- Sponsor's protocol ID
- NMRR-17-1342-36303
- Acronym
- SMART-AF
- Status last verified
- May 2022
- First submitted
- 29 Mar 2020
- Last updated
- 6 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: The final decision is depending on the agreement among the co-investigators.
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smartphone Electrocardiogram for Recording Atrial Fibrillation After a Cerebral Ischemic Event: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04332718
- Acronym / sponsor ID
- SMART-AF / NMRR-17-1342-36303
- Conditions
- Stroke, Atrial Fibrillation
- Keywords
- Stroke, Atrial Fibrillation, Smartphone ECG
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- Sarawak Heart CentreUniversity, hospital or other
- Collaborators
- Ministry of Health, Malaysia
- Study start
- 15 Nov 2017 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 3 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Proportion of patients prescribed oral anticoagulation, as assess at the 30-day follow up.
- Patient adherence with 30-day smartphone ECG monitoring, and percentage of patients using the monitor >75% of the target in 30-day period
- Time to first detection of AF within 30 days (days)
- One year rate of recurrent ischemic stroke or transient ischemic attack, death, hemorrhagic stroke, major adverse bleeding events, detection of AF outside the study protocol.
Exploratory:
To explore the feasibility and cost effectiveness of 30-day smartphone ECG recording for detecting occult paroxysmal atrial fibrillation
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicentre, two-arm, unblinded, randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: Smartphone ECGPatients 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. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
- Patient meets the following:
- At least one 12-lead ECG has already been obtained as part of the routine clinical post-stroke/TIA work up, and not ECGs have shown any episodes of AF or atrial flutter.
- A Holter monitor has already been obtained as part of the routine clinical post-stroke/TIA work-up, and does not show any episodes of AF or atrial flutter ≥30seconds.
- 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.
Key exclusion criteria (3 listed)
- i. Any previously documented atrial fibrillation or atrial flutter (a remote history of transient AF during perioperative period is not exclusionary).
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smartphone ECGAlso: AliveCorPatients 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. | Device | Smartphone ECG |
Primary outcome
Atrial Fibrillation after 30 days
Time frame: 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.
1 secondary outcome
Proportion of patients prescribed with oral anticoagulation, a assess at the 30-day follow-up
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2022.
- Individual participant dataSharing planned: Undecided. The final decision is depending on the agreement among the co-investigators.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keng Tat Koh, MBBS principal investigator
Sarawak Heart Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartphone ECG in people with Stroke and Atrial Fibrillation, run by Sarawak Heart Centre at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Atrial Fibrillation after 30 days (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2022.