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HELP-A study is a single-center, randomized, controlled trial. A total of 588 patients enrolled during the 2 years of enrollment period and followed for 1 month of follow-up period. This study aims to compare diagnostic yield between continuous ECG Patch and intermittent handheld ECG in patients with arrhythmia symptoms.
HELP-A study is a single-center, randomized, controlled trial designed to compare diagnostic yield, arrhythmia detection rate, user convenience, and cost-effectiveness between continuous ECG Patch and intermittent handheld ECG in patients with arrhythmia symptoms. Patients who have symptoms of arrhythmia but are not diagnosed on a 12-lead ECG and require additional tests. A total of 588 patients enrolled during the 2 years of enrollment period and followed for 3 month of follow-up period. Patients will be assigned to continuous patch ECG or intermittent handheld ECG and will be examined for one month. If there is no diagnosis after a month, the patient will be crossed over to another device and examined for another month.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continous ECG Patch | Experimental | In this arm, continuous patch ECG was used. |
|
| Intermittent handheld ECG | Active Comparator | In this arm, intermittent handheld ECG was used. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continous ECG Patch | Device | Using a continuous patch ECG for 1 week during 1 month |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic yield | (Number of patient with triggered event without arrhythmia + Number of patients with clnically significant arrhytmia) / total patients | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Arrhythmia detection rate | Compare the arrhythmia diagnosis rate between the two devices. | 3 month |
| Cost-effectiveness | Compare Total medical cost incurred for arrhythmia symptoms between the two devices |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Young Jun Park, MD | Contact | 82-33-741-0917 | pyj@yonsei.ac.kr |
| Name | Affiliation | Role |
|---|---|---|
| Young Jun Park, MD | Wonju Severance Christian Hopsital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chonnam National University Hospital | Recruiting | Gwangju | Dong-gu Jaebongro 42 | 61469 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21697315 | Background | Raviele A, Giada F, Bergfeldt L, Blanc JJ, Blomstrom-Lundqvist C, Mont L, Morgan JM, Raatikainen MJ, Steinbeck G, Viskin S, Kirchhof P, Braunschweig F, Borggrefe M, Hocini M, Della Bella P, Shah DC; European Heart Rhythm Association. Management of patients with palpitations: a position paper from the European Heart Rhythm Association. Europace. 2011 Jul;13(7):920-34. doi: 10.1093/europace/eur130. No abstract available. | |
| 37286259 |
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| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D004244 | Dizziness |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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In the 588 patients who require additional testing due to arrhythmia symptoms, continuous single lead ECG or intermittent handheld ECG will be randomly assigned to the test for 1 month. If arrhythmia symptoms are not diagnosed after 1 month, cross over the device and use it for another month for evaluation.
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| Intermittent handheld ECG |
| Device |
Using a handheld ECG twice daily and when symptoms are present during 1 month |
|
| 3 month |
| Chagne of Quality of Life | Compare Quality Of Life using Euro QOL-5D-5L between the two devices | Baseline, 3 month |
| User convenience | Comparison of User convenience using questionnaires in patients who used both devices (ease, portability, satisfaction, etc.) The questionnaire consists of 5 scales from 1 to 5 | 3 month |
| Wonju Severance Christian Hospital | Recruiting | Wŏnju | Gangwon-do | 26426 | South Korea |
|
| Hallym University Dongtan Sacred Heart Hospital | Recruiting | Gyeonggi-do | Hwaseong-si Keunjaebong-gil 7 | 18450 | South Korea |
|
| Background |
| Turnbull S, Garikapati K, Bennett RG, Campbell TG, Kotake Y, Mahajan R, Marschner S, Byth K, Chow CK, Kumar S. Utility of a Handheld, Single-Lead ECG Device for Diagnosis of Cardiac Arrhythmias. J Am Coll Cardiol. 2023 Jun 13;81(23):2292-2294. doi: 10.1016/j.jacc.2023.03.428. No abstract available. |
| 24672611 | Background | Schreiber D, Sattar A, Drigalla D, Higgins S. Ambulatory cardiac monitoring for discharged emergency department patients with possible cardiac arrhythmias. West J Emerg Med. 2014 Mar;15(2):194-8. doi: 10.5811/westjem.2013.11.18973. |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |