Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05218473 |
| Other study ID # |
202101821B0C601 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 21, 2022 |
| Est. completion date |
December 31, 2024 |
Study information
| Verified date |
February 2022 |
| Source |
Chang Gung Memorial Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
In this prospective, single-center, open-label, non-randomized, single- arm, historically
controlled study, we will compare the detection rate of paroxysmal atrial fibrillation in
acute ischemic stroke patients without known atrial fibrillation, using 14-day continuous
electrocardiography patch monitoring, with a historical control group of patients who
received serial 12-lead electrocardiograms once daily for five days or conventional 24-hour
Holter monitoring. The study will be conducted in Chang Gung Memorial Hospital at Chiayi,
Taiwan, from February 2022 to December 2024.
Description:
Study design In this prospective, single-center, open-label, non-randomized, single- arm,
historically controlled study, we will compare the detection rate of paroxysmal atrial
fibrillation in acute ischemic stroke patients without known atrial fibrillation, using
14-day continuous ECG patch monitoring, with a historical control group of patients who
received serial 12-lead ECGs or 24-hour Holter monitoring. The study will be conducted in
Chang Gung Memorial Hospital at Chiayi, Taiwan, from February 2022 to December 2024.
Study population Patients are eligible to participate if they meet the inclusion criteria and
without the exclusion criteria. A historical control group will be drawn from our randomized
clinical trial, which have been executed between October 2015 and October 2018, and aimed to
evaluate the detection rate of new atrial fibrillation in acute ischemic stroke patients
without known atrial fibrillation. Patients in the historical control group will have
received serial 12-lead ECGs once daily for five days or conventional 24-hour Holter
monitoring. In this study, serial ECGs had comparable detection rate of paroxysmal atrial
fibrillation compared with 24-hour Holter monitoring. All clinical information and outcomes
have been prospectively recorded.
Trial intervention Eligible patients in this study will receive 14-day continuous ECG patch
monitoring.
A 14-day ECG patch monitor (EZYPRO, UG02, Sigknow Biomedical Co., Ltd, Taipei, Taiwan) was
developed and evaluated in this study. The EZYPRO is a lightweight, waterproof, single-lead
ECG device with no external leads or wires and allows for continuous ECG monitoring for up to
14 days. The data were collected and recorded by the investigators and analyzed with the
proprietary analytical software and qualified ECG technicians from Sigknow Biomedical Co.,
Ltd. and adjudicated by attending cardiologists at the study site.
Study outcomes The primary outcome will be the percentage of patients with new atrial
fibrillation. Atrial fibrillation was defined as an episode of irregular heart rhythm,
without detectable P waves, lasting more than 30 seconds.
Sample size We calculated sample size based on our preliminary data preceding the actual
conduct of this trial. New AF was detected in 7.6% of acute ischemic stroke patients who
received serial ECG or Holter monitoring. Studies with monitoring lasting ≥ 7 days have been
shown to detect AF in 15% of patients after ischemic stroke or transient ischemic attack. The
total sample sizes will be 120 for the long-term monitoring group and 120 for the control
group. The estimated detection rate of new AF is 7.6% for the control group and 20% for the
long-term monitoring group, with 80% power and a two-sided α of 0.05. To allow for dropouts,
150 patients would be recruited in long-term monitoring group.
Statistical analysis Statistical analyses will be performed using the SPSS statistical
software (V.25). The Kolmogorov-Smirnov test will be used to examine the normality of
continuous variables. The Mann-Whitney U test and Student's t-test will be used to test for
differences between the two groups, as appropriate. Categorical data will be analyzed using
the χ2 test. A propensity score matching analysis will be used to measure and balance
predetermined covariates between two groups. A logistic regression model will be used to test
independent variables for the measured outcomes. Variables showing a p value of < 0.1 for
univariate analysis will be entered into the multivariate logistic analysis using the forward
selection method. All tests will be two-tailed, and a p value of < 0.05 is considered to
indicate a statistically significant difference.
