Clinical Trial Details
— Status: Active, not recruiting
Administrative data
NCT number |
NCT05082467 |
Other study ID # |
NMRR-19-3798-52441 |
Secondary ID |
|
Status |
Active, not recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
January 12, 2021 |
Est. completion date |
December 31, 2024 |
Study information
Verified date |
June 2024 |
Source |
Sarawak General Hospital |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial 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.
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)