An observational study in Stroke and Atrial Fibrillation, sponsored by Sarawak General Hospital. Active, not recruiting at 1 site in Malaysia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-24.
Sponsored by Sarawak General Hospital · 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.
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):
Exploratory objective(s):
SCREENING:
Eligible patients will be enrolled in the study and proceed with a baseline assessment.
BASELINE ASSESSMENT:
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:
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's enrollment of 320 is above the median of 152 across 1,968 observational studies indexed under Stroke.
Browse Stroke studies →Sarawak General Hospital is the lead sponsor of 9 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Diagnosis of acute ischemic stroke or (TIA) (WHO definition) of undetermined etiology made by neurologist within 7 days after the index event. The event must be either:
The following diagnostic test have already been completed as part of clinical routine post-stroke/TIA:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Time frame: 24 hours
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.
Time frame: 7 days
Proportion of stroke patients anticoagulated during follow-up.
Proportion of patients prescribed with OAC as assessed at 3 month follow-up.
Time frame: 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.
Time frame: 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.
Time frame: 7 days
Health Outcomes.
Health outcome as evaluated by Eq-5D Questionnaire.
Time frame: 1 year
Predictors of occult AF.
To identify predictors of occult AF based on clinical, neuroimaging, echocardiography and Holter monitoring results.
Time frame: 1 month
Plan to share: Undecided — The final decision is depending on the agreement among the co-investigators.
No publications or documents are linked to this record.
Started Jan 2021 (actual). Primary completion is estimated for Aug 2027, 79 months after the start.
Of 835 non-industry observational studies under Stroke, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 92. This study's planned 79 months is above that.
Counting every sponsor, half of 897 studies reached it within 40 months; a quarter within 18 and three quarters within 85.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Sarawak General Hospital