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

NCT05082467 | Active Not Recruiting DMC

• 1 other identifier: NMRR-19-3798-52441
• Study Type: observational
• Target: 320
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke; Atrial Fibrillation

Keywords

Stroke; Atrial Fibrillation; Cardiac ECG Patch

Outcome Measures

Primary Outcomes (1)

• 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.

  24 hours

Secondary Outcomes (5)

• Detection of AF or atrial flutter within 7 days of monitoring.

  7 days

• Proportion of stroke patients anticoagulated during follow-up.

  3 months

• Rate of stroke recurrent, major adverse bleeding events and detection of AF outside the study protocol.

  1 year

• Time to first detection of AF or atrial flutter.

  7 days

• Health Outcomes.

  1 year

Other Outcomes (1)

• Predictors of occult AF.

  1 month

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• Stroke of unknown time of symptom onset.
• Modified Rankin Scale ≥5 on index admission.
• Previous documented history of primary intracerebral bleeding.
• 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).
• 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.

Sponsors & Collaborators

• Sarawak General Hospital: lead
• Sarawak Heart Centre: collaborator
• Ministry of Health, Malaysia: collaborator

Study Sites (1)

Sarawak General Hospital

Kuching, Sarawak, 93586, Malaysia

Location

MeSH Terms

Conditions

Stroke; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Diana Hui Ping Foo, MD

  Sarawak General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 5, 2021
• First Posted: October 19, 2021
• Study Start: January 12, 2021
• Primary Completion (Estimated): August 22, 2027
• Study Completion (Estimated): August 22, 2027
• Last Updated: April 24, 2026

Record last verified: 2026-04

Locations

MY (1)