Ignite Creation Date:
2025-12-25 @ 12:53 AM
Ignite Modification Date:
2026-02-27 @ 8:27 AM
Study NCT ID:
NCT05082467
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-18
First Post:
2021-10-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prolonged Cardiac ECG Patch Versus Conventional Holter For Detecting Atrial Fibrillation After Cerebral Ischemic Event
Sponsor:
Sarawak General Hospital
Organization:
Study Overview
Official Title:
Prolonged Cardiac Patch Ambulatory Electrocardiogram Versus Conventional Holter Recording For Detection of Atrial Fibrillation After Cerebral Ischemic Event: A Comparative Analysis
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-05
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:
PROVE-AF
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.
Detailed Description:
This is a cohort study with a paired comparison between a cardiac ECG patch and conventional Holter system to detect atrial fibrillation in patients with acute ischemic stroke or transient ischemic attack of undetermined etiology. An estimated total of 320 adult patients will be enrolled in this study. Each eligible patient will receive simultaneously a conventional 24h Holter monitoring and a 7d cardiac ECG patch monitoring.
OBJECTIVES:
Primary objective:
To determine the diagnostic yield of a cardiac ECG patch compared to conventional Holter monitor for detecting occult paroxysmal atrial fibrillation (AF) within 24 hours in patients admitted with acute ischemic stroke or transient ischemic attack (TIA) of undetermined etiology after completion of a standard clinical stroke work-up.
Secondary objective(s):
* To determine efficacy of prolonged 7-day ambulatory ECG monitoring (using cardiac ECG patch) compared to conventional 24-hour ambulatory ECG monitoring (using conventional Holter) strategies in detecting paroxysmal AF.
* To determine if a strategy of a prolonged 7-day ambulatory ECG monitoring results in a change in clinical practice, i.e., more patients are anticoagulated.
* To assess the time to the first detection of AF within the first 7 days of monitoring.
Exploratory objective(s):
* To identify predictors of occult AF based on clinical, neuroimaging, echocardiography, and ECG features.
* To assess feasibility and cost-effectiveness of 7-day cardiac ECG patch monitoring for detecting occult paroxysmal AF.
SCREENING:
* Written informed consent obtained from patient or guardian
* Inclusion/Exclusion criteria.
* Social demographics, Risk factors, Comorbidities, Admission Brain CT/MRI,Stroke status including date and time of index event, date and time of admission, admission modified Rankin scale/NIHSS Score \[Data extracted from patient records\].
* 12-lead ECG, Transthoracic Echocardiogram
Eligible patients will be enrolled in the study and proceed with a baseline assessment.
BASELINE ASSESSMENT:
* Concomitant medication, Oxfordshire classification of stroke and CHA2DS2VAS Score \[Data extracted from patient records\].
* Anthropometric measurements and vital signs assessments
* 24h Holter and 7d Cardiac ECG patch monitoring
FOLLOW UP VISITS:
Follow-up visits will occur at 3 months and 1 year for the efficacy and outcomes for the duration of the study. There will be a total of 2 visits.The investigator/study team will perform the following procedures at each visit where applicable:
* Clinical examination (NIHSS Score assessment)
* Review concomitant medications
* AE/SAE assessment and monitoring
* Outcomes assessment
* Health outcome interview with EQ-5D Questionnaire
* TOAST Classification (at 1 year follow up visit)
OBJECTIVES:
Primary objective:
To determine the diagnostic yield of a cardiac ECG patch compared to conventional Holter monitor for detecting occult paroxysmal atrial fibrillation (AF) within 24 hours in patients admitted with acute ischemic stroke or transient ischemic attack (TIA) of undetermined etiology after completion of a standard clinical stroke work-up.
Secondary objective(s):
* To determine efficacy of prolonged 7-day ambulatory ECG monitoring (using cardiac ECG patch) compared to conventional 24-hour ambulatory ECG monitoring (using conventional Holter) strategies in detecting paroxysmal AF.
* To determine if a strategy of a prolonged 7-day ambulatory ECG monitoring results in a change in clinical practice, i.e., more patients are anticoagulated.
* To assess the time to the first detection of AF within the first 7 days of monitoring.
Exploratory objective(s):
* To identify predictors of occult AF based on clinical, neuroimaging, echocardiography, and ECG features.
* To assess feasibility and cost-effectiveness of 7-day cardiac ECG patch monitoring for detecting occult paroxysmal AF.
SCREENING:
* Written informed consent obtained from patient or guardian
* Inclusion/Exclusion criteria.
* Social demographics, Risk factors, Comorbidities, Admission Brain CT/MRI,Stroke status including date and time of index event, date and time of admission, admission modified Rankin scale/NIHSS Score \[Data extracted from patient records\].
* 12-lead ECG, Transthoracic Echocardiogram
Eligible patients will be enrolled in the study and proceed with a baseline assessment.
BASELINE ASSESSMENT:
* Concomitant medication, Oxfordshire classification of stroke and CHA2DS2VAS Score \[Data extracted from patient records\].
* Anthropometric measurements and vital signs assessments
* 24h Holter and 7d Cardiac ECG patch monitoring
FOLLOW UP VISITS:
Follow-up visits will occur at 3 months and 1 year for the efficacy and outcomes for the duration of the study. There will be a total of 2 visits.The investigator/study team will perform the following procedures at each visit where applicable:
* Clinical examination (NIHSS Score assessment)
* Review concomitant medications
* AE/SAE assessment and monitoring
* Outcomes assessment
* Health outcome interview with EQ-5D Questionnaire
* TOAST Classification (at 1 year follow up visit)
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: