StrokePROVE-AFNCT05082467
Prolonged Cardiac ECG Patch Versus Conventional Holter For Detecting Atrial Fibrillation After Cerebral Ischemic Event
An observational study of Stroke and Atrial Fibrillation, run by Sarawak General Hospital at 1 site in Malaysia.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Atrial Fibrillation
- How many people
- 320 participants
- Where
- 1 siteMalaysia
- Study dates
- 12 Jan 2021to 22 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients who are admitted with acute ischemic stroke or transient ischemic attack (TIA) of undetermined etiology after completion of a standard clinical stroke work-up will be included.
Who may be able to join
- Age ≥18 years.
- 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).
- No AF detected in baseline 12-lead ECG on admission.
- The following diagnostic test have already been completed as part of clinical routine post-stroke/TIA:
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- Brain imaging with CT or MRI,
- Transthoracic echocardiography to congenital heart disease and endocarditis.
- Recurrent stroke/TIA is inclusionary as long as patient meets inclusion/exclusion criteria for study enrolment.
Who cannot join
- Stroke of unknown time of symptom onset.
- Modified Rankin Scale ≥5 on index admission.
- Previous documented history of primary intracerebral bleeding.
- Previous documented history of AF or atrial flutter (a remote history of transient AF during perioperative period is not exclusionary).
- Skin allergies, conditions, or sensitivities to cardiac patch.
- Exclusively retinal stroke or retinal TIA event.
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- Pre-existing indication for anticoagulation (eg. History of mechanical heart valve replacement, deep vein thrombosis).
- Pre-existing contraindication for permanent anticoagulation (eg. hypocoagulable state).
- Echocardiographic findings of congenital heart disease and endocarditis.
- Indicated for pacemaker, implantable cardiac defibrillator (ICD), CRT device, or an implantable hemodynamic monitoring system.
- Intravenous drug users (IVDUs).
- Life expectancy < 1 year for reasons other than stroke (eg. Metastatic cancer disease).
- Concomitant participation in other clinical trials involving investigational medications.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prolonged Cardiac Patch Ambulatory Electrocardiogram Versus Conventional Holter Recording For Detection of Atrial Fibrillation After Cerebral Ischemic Event: A Comparative Analysis
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.
Read the detailed description
This is a cohort study with a paired comparison between a cardiac ECG patch and conventional Holter system to detect atrial fibrillation in patients with acute ischemic stroke or transient ischemic attack of undetermined etiology. An estimated total of 320 adult patients will be enrolled in this study. Each eligible patient will receive simultaneously a conventional 24h Holter monitoring and a 7d cardiac ECG patch monitoring.
OBJECTIVES:
Primary objective:
To determine the diagnostic yield of a cardiac ECG patch compared to conventional Holter monitor for detecting occult paroxysmal atrial fibrillation (AF) within 24 hours in patients admitted with acute ischemic stroke or transient ischemic attack (TIA) of undetermined etiology after completion of a standard clinical stroke work-up.
Secondary objective(s):
- To determine efficacy of prolonged 7-day ambulatory ECG monitoring (using cardiac ECG patch) compared to conventional 24-hour ambulatory ECG monitoring (using conventional Holter) strategies in detecting paroxysmal AF.
- To determine if a strategy of a prolonged 7-day ambulatory ECG monitoring results in a change in clinical practice, i.e., more patients are anticoagulated.
- To assess the time to the first detection of AF within the first 7 days of monitoring.
Exploratory objective(s):
- To identify predictors of occult AF based on clinical, neuroimaging, echocardiography, and ECG features.
- To assess feasibility and cost-effectiveness of 7-day cardiac ECG patch monitoring for detecting occult paroxysmal AF.
SCREENING:
- Written informed consent obtained from patient or guardian
- Inclusion/Exclusion criteria.
- Social demographics, Risk factors, Comorbidities, Admission Brain CT/MRI,Stroke status including date and time of index event, date and time of admission, admission modified Rankin scale/NIHSS Score [Data extracted from patient records].
- 12-lead ECG, Transthoracic Echocardiogram
Eligible patients will be enrolled in the study and proceed with a baseline assessment.
BASELINE ASSESSMENT:
- Concomitant medication, Oxfordshire classification of stroke and CHA2DS2VAS Score [Data extracted from patient records].
- Anthropometric measurements and vital signs assessments
- 24h Holter and 7d Cardiac ECG patch monitoring
FOLLOW UP VISITS:
Follow-up visits will occur at 3 months and 1 year for the efficacy and outcomes for the duration of the study. There will be a total of 2 visits.The investigator/study team will perform the following procedures at each visit where applicable:
- Clinical examination (NIHSS Score assessment)
- Review concomitant medications
- AE/SAE assessment and monitoring
- Outcomes assessment
- Health outcome interview with EQ-5D Questionnaire
- TOAST Classification (at 1 year follow up visit)
- Conditions
- Stroke, Atrial Fibrillation
- Keywords
- Stroke, Atrial Fibrillation, Cardiac ECG Patch
- Medical subject headings
- Stroke, Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours
Secondary outcomes (5)
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.
Measured: 7 days
Proportion of stroke patients anticoagulated during follow-up.
Proportion of patients prescribed with OAC as assessed at 3 month follow-up.
Measured: 3 months
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.
Measured: 1 year
Time to first detection of AF or atrial flutter.
Time to first detection of AF or atrial flutter within 7 days of Holter monitoring.
Measured: 7 days
Health Outcomes.
Health outcome as evaluated by Eq-5D Questionnaire.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study start12 Jan 2021
- Primary completion22 Aug 2027 (estimated)
- Study completion22 Aug 2027 (estimated)
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sarawak General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sarawak Heart Centre, Ministry of Health, Malaysia
- Responsible party
- Principal investigator, Diana Hui Ping Foo, Sarawak General Hospital
- Investigators
- Diana Hui Ping Foo, MD, Principal investigator, Sarawak General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05082467
- Sponsor's protocol ID
- NMRR-19-3798-52441
- Acronym
- PROVE-AF
- Status last verified
- Apr 2026
- First submitted
- 5 Oct 2021
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- 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 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prolonged Cardiac Patch Ambulatory Electrocardiogram Versus Conventional Holter Recording For Detection of Atrial Fibrillation After Cerebral Ischemic Event: A Comparative Analysis
- ClinicalTrials.gov ID
- NCT05082467
- Acronym / sponsor ID
- PROVE-AF / NMRR-19-3798-52441
- Conditions
- Stroke, Atrial Fibrillation
- Keywords
- Stroke, Atrial Fibrillation, Cardiac ECG Patch
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Sarawak General HospitalUniversity, hospital or other
- Collaborators
- Sarawak Heart Centre, Ministry of Health, Malaysia
- Study start
- 12 Jan 2021 (actual)
- Primary completion
- 22 Aug 2027 (estimated)
- Study completion
- 22 Aug 2027 (estimated)
- First posted
- 19 Oct 2021 (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.
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.
Detailed description
This is a cohort study with a paired comparison between a cardiac ECG patch and conventional Holter system to detect atrial fibrillation in patients with acute ischemic stroke or transient ischemic attack of undetermined etiology. An estimated total of 320 adult patients will be enrolled in this study. Each eligible patient will receive simultaneously a conventional 24h Holter monitoring and a 7d cardiac ECG patch monitoring.
OBJECTIVES:
Primary objective:
To determine the diagnostic yield of a cardiac ECG patch compared to conventional Holter monitor for detecting occult paroxysmal atrial fibrillation (AF) within 24 hours in patients admitted with acute ischemic stroke or transient ischemic attack (TIA) of undetermined etiology after completion of a standard clinical stroke work-up.
Secondary objective(s):
- To determine efficacy of prolonged 7-day ambulatory ECG monitoring (using cardiac ECG patch) compared to conventional 24-hour ambulatory ECG monitoring (using conventional Holter) strategies in detecting paroxysmal AF.
- To determine if a strategy of a prolonged 7-day ambulatory ECG monitoring results in a change in clinical practice, i.e., more patients are anticoagulated.
- To assess the time to the first detection of AF within the first 7 days of monitoring.
Exploratory objective(s):
- To identify predictors of occult AF based on clinical, neuroimaging, echocardiography, and ECG features.
- To assess feasibility and cost-effectiveness of 7-day cardiac ECG patch monitoring for detecting occult paroxysmal AF.
SCREENING:
- Written informed consent obtained from patient or guardian
- Inclusion/Exclusion criteria.
- Social demographics, Risk factors, Comorbidities, Admission Brain CT/MRI,Stroke status including date and time of index event, date and time of admission, admission modified Rankin scale/NIHSS Score [Data extracted from patient records].
- 12-lead ECG, Transthoracic Echocardiogram
Eligible patients will be enrolled in the study and proceed with a baseline assessment.
BASELINE ASSESSMENT:
- Concomitant medication, Oxfordshire classification of stroke and CHA2DS2VAS Score [Data extracted from patient records].
- Anthropometric measurements and vital signs assessments
- 24h Holter and 7d Cardiac ECG patch monitoring
FOLLOW UP VISITS:
Follow-up visits will occur at 3 months and 1 year for the efficacy and outcomes for the duration of the study. There will be a total of 2 visits.The investigator/study team will perform the following procedures at each visit where applicable:
- Clinical examination (NIHSS Score assessment)
- Review concomitant medications
- AE/SAE assessment and monitoring
- Outcomes assessment
- Health outcome interview with EQ-5D Questionnaire
- TOAST Classification (at 1 year follow up visit)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients who are admitted with acute ischemic stroke or transient ischemic attack (TIA) of undetermined etiology after completion of a standard clinical stroke work-up will be included.
Key inclusion criteria (9 listed)
- Age ≥18 years.
- 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:
- No AF detected in baseline 12-lead ECG on admission.
- The following diagnostic test have already been completed as part of clinical routine post-stroke/TIA:
- Recurrent stroke/TIA is inclusionary as long as patient meets inclusion/exclusion criteria for study enrolment.
Key exclusion criteria (14 listed)
- Stroke of unknown time of symptom onset.
- Modified Rankin Scale ≥5 on index admission.
- Previous documented history of primary intracerebral bleeding.
- Previous documented history of AF or atrial flutter (a remote history of transient AF during perioperative period is not exclusionary).
- Skin allergies, conditions, or sensitivities to cardiac patch.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Detection of newly diagnosed AF or atrial flutter within 24 hours of monitoring with cardiac ECG patch compared to conventional Holter.
Time frame: 24 hours
Detection of newly diagnosed AF or atrial flutter within 24 hours of monitoring with cardiac ECG patch compared to conventional Holter.
5 secondary outcomes
Detection of AF or atrial flutter within 7 days of monitoring.
Time frame: 7 days
Proportion of stroke patients anticoagulated during follow-up.
Time frame: 3 months
Rate of stroke recurrent, major adverse bleeding events and detection of AF outside the study protocol.
Time frame: 1 year
Time to first detection of AF or atrial flutter.
Time frame: 7 days
Health Outcomes.
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- 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.
Diana Hui Ping Foo, MD principal investigator
Sarawak General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Atrial Fibrillation, run by Sarawak General Hospital 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 9 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 24 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Detection of newly diagnosed AF or atrial flutter within 24 hours of monitoring with cardiac ECG patch compared to conventional Holter. (time frame: 24 hours). 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 24 Apr 2026.