Smartphone Electrocardiogram for Recording Atrial Fibrillation After a Cerebral Ischemic Event

NCT04332718 | Completed DMC FDA Device

• 1 other identifier: NMRR-17-1342-36303
• Study Type: interventional
• Target: 236
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the diagnostic yield of a 30-day smartphone electrocardiogram recording compared to 24-hour Holter monitor for detecting occult paroxysmal atrial fibrillation in patients with a recent ischemic stroke or transient ischemic attack of undetermined etiology after completion of a standard clinical stroke work-up.

Conditions

Stroke; Atrial Fibrillation

Keywords

Stroke; Atrial Fibrillation; Smartphone ECG

Outcome Measures

Primary Outcomes (1)

• Atrial Fibrillation after 30 days

  Detection of one or more episodes of atrial fibrillation or atrial flutter ≥30 seconds as assessed at the 30 day follow-up. This will be reported as number of patient detected to have atrial fibrillation after 30 days.

  30 days

Secondary Outcomes (1)

• Proportion of patients prescribed with oral anticoagulation, a assess at the 30-day follow-up

  30 days

Study Arms (2)

24 Hour Holter

NO INTERVENTION

Patients who are randomised to the 24 Hour Holter monitoring will be contacted within one month from randomisation. The repeat 24 Hour Holter result will be explained to the patient at the end of 30-day follow-up.

Smartphone ECG

ACTIVE COMPARATOR

Patients who are randomised to the 30-day smartphone ECG monitoring will be contacted within one month from randomisation. Patients will be taught on how to use the smartphone ECG monitoring. Patients are required to monitor their ECG 3 times a day for 30 days. Patients will be contacted during the monitoring period to assess for compliance and to ensure that the recording is done correctly.

Device: Smartphone ECG

Interventions

Smartphone ECG DEVICE

Patients who are randomised to the 30-day smartphone ECG monitoring will be contacted within one month from randomisation. Patients will be taught on how to use the smartphone ECG monitoring. Patients are required to monitor their ECG 3 times a day for 30 days. Patients will be contacted during the monitoring period to assess for compliance and to ensure that the recording is done correctly.

Also known as: AliveCor

Smartphone ECG

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• i. Age 55 years or older. ii. Diagnosis of the index event made by neurologist or general physician of an acute ischemic stroke or TIA (WHO definition) of undetermined etiology occurring within the previous 6 months (180 days). The event must be either:
• An ischemic stroke confirmed by neuroimaging; or
• A transient ischemic attack, 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).
• iii. Patient meets the following:
• At least one 12-lead ECG has already been obtained as part of the routine clinical post-stroke/TIA work up, and not ECGs have shown any episodes of AF or atrial flutter.
• A Holter monitor has already been obtained as part of the routine clinical post-stroke/TIA work-up, and does not show any episodes of AF or atrial flutter ≥30seconds.
• iv. The patient is being actively investigated for the etiology of the stroke/TIA event and additional cardiac monitor is desired to screen further for the possibility of AF or atrial flutter.
• v. The following diagnostic test have already been completed as part of clinical routine post-stroke/TIA:
• Brain imaging with CT or MRI
• Vascular imaging of the extracranial and intracranial circulation with either CT angiography or MRI angiography to exclude significant large vessel occlusion disease as the most likely mechanism for index ischemic event (carotid Doppler ultrasound is acceptable for those presenting with anterior circulation ischemic events).\*
• Transthoracic (or transesophageal) echocardiography to exclude thrombus or other structural heart disease that in the opinion of the investigator is the most likely cause for the stroke/TIA events.\* \*(if a baseline investigation cannot be obtained clinically after the index event and prior to study enrolment, then it is acceptable for study purposes for investigations to be obtained after patient enrolment into the study but prior to the 90-day follow-up visit.) vi. Informed consent from the patient (or from a legally authorised representative if the patient is not competent, due to stroke-related cognitive impairment, aphasia, or anosognosia).
• vii. The patient is expected to survive at least 12 months.

You may not qualify if:

• ii. Exclusively retinal stroke or retinal TIA event. iii. A most responsible etiological diagnosis for the qualifying stroke/TIA event has already determined i.e. cervicocephalic artery dissection, venous sinus thrombosis, hypercoagulable states, or other known cause.
• iv. Planned carotid endarterectomy within 90 days. v. Any finding on echocardiography for which there is already an evidence-based indication for long-term anticoagulation (e.g. mechanical heart valve, thrombus, etc) vi. Inability to use the AliveCor smartphone ECG monitor upon enrolment into the study (if patient is randomised into interventional group).\* vii. Participating in a clinical trial involving investigational medication. viii. Endocarditis. ix. Pregnancy.

Sponsors & Collaborators

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

Study Sites (1)

SarawakHC

Kuching, Sarawak, 94300, 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

• Keng Tat Koh, MBBS

  Sarawak Heart Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Cardiologist

Model Details: Multicentre, two-arm, unblinded, randomised controlled trial

Study Record Dates

• First Submitted: March 29, 2020
• First Posted: April 3, 2020
• Study Start: November 15, 2017
• Primary Completion: June 30, 2020
• Study Completion: July 30, 2021
• Last Updated: May 6, 2022

Record last verified: 2022-05

Locations

MY (1)