Status Approved
First Submitted Date
2021/03/19
Registered Date
2021/03/25
Last Updated Date
2021/03/19
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0006027 |
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Unique Protocol ID | SCHCA 2021-02-043 |
Public/Brief Title | ECG monitoring with novel wireless machine in patients with cryptogenic Ischemic stroke |
Scientific Title | ECG monitoring with novel wireless machine in patients with cryptogenic Ischemic stroke |
Acronym | |
MFDS Regulated Study | No |
IND/IDE Protocol | No |
Registered at Other Registry | No |
Healthcare Benefit Approval Status | Not applicable |
2. Institutional Review Board / Ethics Committee
Board Approval Status | Submitted approval |
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Board Approval Number | SCHCA 2021-02-043 |
Approval Date | 2021-03-05 |
Institutional Review Board Name | Soon Chun Hyang University Hospital Cheonan IRB |
Institutional Review Board Address | 31, Suncheonhyang 6-gil, Dongnam-gu, Cheonan-si, Chungcheongnam-do |
Institutional Review Board Telephone | 041-570-2985 |
Data Monitoring Committee |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
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Name | Hyo-wook Gil |
Title | Prof |
Telephone | +82-41-570-3671 |
Affiliation | Soon Chun Hyang University Hospital Cheonan |
Address | 31 Suncheonhyang 6-gil, Dongnam-gu, Cheonan-si, Chungcheongnam-do |
Contact Person for Public Queries | |
Name | Hanna Lee |
Title | CRN |
Telephone | +82-41-570-3677 |
Affiliation | Soon Chun Hyang University Hospital Cheonan |
Address | 31 Suncheonhyang 6-gil, Dongnam-gu, Cheonan-si, Chungcheongnam-do |
Contact Person for Updating Information | |
Name | Hanna Lee |
Title | CRN |
Telephone | +82-41-570-3677 |
Affiliation | Soon Chun Hyang University Hospital Cheonan |
Address | 31 Suncheonhyang 6-gil, Dongnam-gu, Cheonan-si, Chungcheongnam-do |
4. Status
Study Site | Single | |
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Overall Recruitment Status | Not yet recruiting | |
Date of First Enrollment | 2021-04-01 Anticipated | |
Target Number of Participant | 87 | |
Primary Completion Date | 2021-12-01 , Anticipated | |
Study Completion Date | 2021-12-01 , Anticipated | |
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Soon Chun Hyang University Hospital Cheonan | |
Recruitment Status | Not yet recruiting | |
Date of First Enrollment | 2021-04-01 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
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Organization Name | National Research Foundation |
Organization Type | Government |
Project ID | 2019M3E5D1A02069073 |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Soon Chun Hyang University Hospital Cheonan |
Organization Type | Medical Institute |
7. Study Summary
Lay Summary | In about 20-40% of ischemic strokes, the exact cause has not been determined, which is defined as “cryptogenic stroke”. Atrial fibrillation(Af) is a major risk factor for ischemic stroke and at least 30% of patients with cryptogenic stroke have paroxysmal Af, but often remains undiagnosed in patients who have had an acute ischemic stroke. The detection of Af in patients with acute ischemic stroke is of major clinical relevance, because it usually shifts the secondary prevention therapy from antiplatelet drugs to oral anticoagulation. Oral anticoagulation therapy leads to a 60-70% relative risk reduction of recurrent strokes in those with Af, compared with placebo. However, due to the paroxysmal and asymptomatic nature of Af, Af might escape routine short-term electrocardiogram (ECG)-monitoring. Therefore, there are many strategies to improved the detection of Af, including in-hospital monitoring, serial electrocardiography and Holter monitoring, and the use of loop recorders or insertable cardiac monitors. In recent years, the wearable device (smart watch, pads...) for continuous ambulatory ECG recording have developed and expected to enhance the recognition ability of Af, but clinical experience with those products is limited. We therefore will investigate whether wireless ECG monitoring patch (which developed by Korean company Seerstech) is better for detection of Af than standard care procedures in patients with acute cryptogenic ischemic stroke. |
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8. Study Design
Study Type | Observational Study |
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Observational Study Model | Cohort |
Time Perspective | Prospective |
Target Number of Participant | 87 |
Cohort/Group Number | 1 |
Cohort/ Group 1 |
Cohort/Group Label Cryptogenic ischemic stroke patients with wireless ECG monitoring patch |
Cohort/Group Description Cryptogenic inschemic stroke patients are observed in a cohort. Atrial fibrillation detection rates are observed in patients with wireless ECG monitoring patches in cryotogeni ischemic stroke patients. |
|
Biospecimen Collection & Archiving |
Not collect nor Archive |
Biospecimen Description |
9. Subject Eligibility
Study Population Description | Patients aged 19 or older who have been hospitalized with cryotogenic ischemic stroke at Soonhunhyang University Cheonan Hospital within seven days. |
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Sampling Method | The sample size estimation is based findings of the previous trial Find-AF (Lancet Neurol 2017; 16: 282-290). |
Condition(s)/Problem(s) |
* (I00-I99)Diseases of the circulatory system (I62.9)Intracranial haemorrhage(nontraumatic), unspecified Cryptogenic Ischemic Stroke |
Rare Disease | No |
Inclusion Criteria |
Gender Both |
Age 19Year~No Limit |
|
Description 1. Patients who have been hospitalized with cryotogenic ischemic stroke at Soonhunhyang University Cheonan Hospital (clinical symptom onset < 7days) 2. Patients who agree to participate in this study 3. Age ; 19 years or older |
|
Exclusion Criteria |
1. Patients with known or documented atrial fibrillation. 2. Patients with ipsilateral carotid stenosis (>50% according to the North American Symptomatic Carotid Endarterectomy Trial [NASCET] classification) 3. Patients with clinically significant vertebral artery stenosis of more than 50%, and those with acute arterial dissections. 4. Patients with a pacemaker inserted 5. Children 6. Pregnant women 7. Patients with allergic reactions to patches. |
Healthy Volunteers | No |
10. Outcome Measure(s)
Type of Primary Outcome | Efficacy | |
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Primary Outcome(s) 1 | ||
Outcome | The detection rate of atrial fibrillation |
|
Timepoint | After removing the wireless ECG monitoring patch at the time of discharge |
|
Secondary Outcome(s) 1 | ||
Outcome | The detection rate of other arrhythmia except atrial fibrillation |
|
Timepoint | After removing the wireless ECG monitoring patch at the time of discharge |
11. Study Results and Publication
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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