Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:58 AM
Study NCT ID:
NCT04332718
Status:
COMPLETED
Last Update Posted:
2022-05-06
First Post:
2020-03-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Smartphone Electrocardiogram for Recording Atrial Fibrillation After a Cerebral Ischemic Event
Sponsor:
Sarawak Heart Centre
Organization:
Study Overview
Official Title:
Smartphone Electrocardiogram for Recording Atrial Fibrillation After a Cerebral Ischemic Event: A Randomised Controlled Trial
Status:
COMPLETED
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SMART-AF
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.
Detailed Description:
Study outcomes
Primary:
Detection of one or more episodes of atrial fibrillation or atrial flutter ≥30 seconds as assessed at the 30 day follow-up.
Secondary:
1. Proportion of patients prescribed oral anticoagulation, as assess at the 30-day follow up.
2. Patient adherence with 30-day smartphone ECG monitoring, and percentage of patients using the monitor \>75% of the target in 30-day period
3. Time to first detection of AF within 30 days (days)
4. One year rate of recurrent ischemic stroke or transient ischemic attack, death, hemorrhagic stroke, major adverse bleeding events, detection of AF outside the study protocol.
Exploratory:
To explore the feasibility and cost effectiveness of 30-day smartphone ECG recording for detecting occult paroxysmal atrial fibrillation
Primary:
Detection of one or more episodes of atrial fibrillation or atrial flutter ≥30 seconds as assessed at the 30 day follow-up.
Secondary:
1. Proportion of patients prescribed oral anticoagulation, as assess at the 30-day follow up.
2. Patient adherence with 30-day smartphone ECG monitoring, and percentage of patients using the monitor \>75% of the target in 30-day period
3. Time to first detection of AF within 30 days (days)
4. One year rate of recurrent ischemic stroke or transient ischemic attack, death, hemorrhagic stroke, major adverse bleeding events, detection of AF outside the study protocol.
Exploratory:
To explore the feasibility and cost effectiveness of 30-day smartphone ECG recording for detecting occult paroxysmal atrial fibrillation
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: