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NCT05082467Active, not recruiting

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

Prolonged Cardiac Patch Ambulatory Electrocardiogram Versus Conventional Holter Recording For Detection of Atrial Fibrillation After Cerebral Ischemic Event: A Comparative Analysis

Source: ClinicalTrials.gov · Last updated 24 Apr 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
320 (actual)
First submitted
5 Oct 2021
Start date
12 Jan 2021
Primary completion date
22 Aug 2027
Lead sponsor
Sarawak General Hospital
NCT number
NCT05082467

What you commit to

  • Study type: Observational
  • Participants enrolled: 320
  • From 12 Jan 2021 to the primary completion date, 22 Aug 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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).
  • Intravenous drug users (IVDUs).
  • Concomitant participation in other clinical trials involving investigational medications.

Other illness

  • Stroke of unknown time of symptom onset.
  • 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).
  • Echocardiographic findings of congenital heart disease and endocarditis.
  • Indicated for pacemaker, implantable cardiac defibrillator (ICD), CRT device, or an implantable hemodynamic monitoring system.
  • Life expectancy \< 1 year for reasons other than stroke (eg. Metastatic cancer disease).

Other

  • Modified Rankin Scale ≥5 on index admission.
  • Pre-existing contraindication for permanent anticoagulation (eg. hypocoagulable state).
  • Pregnancy.

Who the study is looking for

  • 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:
    • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Sarawak General Hospital
Coordinator of this site? Confirm its status
KuchingMalaysiaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.