Could a Week-Long heart patch catch more hidden strokes?
NCT ID NCT05082467
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether a water-resistant, wireless ECG patch worn for 7 days can detect more cases of hidden atrial fibrillation (a heart rhythm problem that raises stroke risk) than the usual 24-hour Holter monitor. Researchers will enroll 320 adults who recently had a stroke or mini-stroke of unknown cause. The goal is to see if the longer monitoring period leads to better detection and more appropriate blood-thinner use.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- 7-day wireless ECG patch
- What this could lead to
- If successful, this could show that a longer monitoring period with a comfortable patch finds more cases of hidden atrial fibrillation after a stroke, helping doctors decide on blood-thinning treatment to prevent another stroke.
- What could go wrong
- This is a single-center study with 320 participants, so results may not apply to all patients. The patch might not detect all cases, and the study does not test whether finding more AF actually reduces strokes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
-
320 people
The number who actually took part.
- Started
-
Jan 2021
- Expected to finish
-
Aug 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Sarawak General Hospital
Kuching, Sarawak, 93586, Malaysia
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