Active — Not RecruitingNot Applicable

Prolonged Cardiac ECG Patch Versus Conventional Holter For Detecting Atrial Fibrillation After Cerebral Ischemic Event

Malaysia320 participantsStarted 2021-01-12

Plain-language 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 of a standard clinical stroke workup.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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:

Exclusion criteria

✕. 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.
✕. Pre-existing indication for anticoagulation (eg. History of mechanical heart valve replacement, deep vein thrombosis).
✕. Pre-existing contraindication for permanent anticoagulation (eg. hypocoagulable state).

What they're measuring

Detection of newly diagnosed AF or atrial flutter within 24 hours of monitoring with cardiac ECG patch compared to conventional Holter.

Timeframe: 24 hours

Trial details

NCT IDNCT05082467

SponsorSarawak General Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-08-22

View on ClinicalTrials.gov More Stroke trials