A Major Determinant Focused on the ECG or Echocardiogram for PICM and Its Clinical Outcome (PICM Syndrome)

NCT03475498 — Recruiting, 1000 participants, Eulji University Hospital

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A Major Determinant Focused on the ECG or Echocardiogram for Pacing-induced Cardiomyopathy (PICM) and Its Clinical Outcome (PICM Syndrome) : Prospective, Multi-center, Observational Cohort Study.

Registry	NCT03475498
Status	Recruiting
Study type	Observational
Enrollment	1000 (Estimated)
Sponsor	Eulji University Hospital (Other); collaborators: Chungnam National University Hospital, Chungbuk National University Hospital, Dankook University, Chung-Ang University Hospital
Conditions	Pacemaker Complication
Dates	start 2018-01-30, primary completion 2027-02-28 (estimated), completion 2028-02-28 (estimated), first posted 2018-03-23, last updated 2025-10-02
Locations	3 sites in South Korea

-Summary

Chronic right ventricular pacing has a deleterious effect on left ventricular (LV) function, namely pacing-induced cardiomyopathy (PICM). Several parametes make difference of effect on the occurrence of PICM and its subsequent clinical outcomes. In particular, recognition of a major determinant focused on the ECG or echocardiographic parameters including strain or genetic factor for occurrence of PICM may lead to better identification of patients at high risk. Investigators prospectively enroll a participant with documented high risk of PICM and clinically follow-up to idenify clinical impact of PICM (PICM syndrome) over a long period of time.

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+Detailed description

Investigators investigate a major determinant focused on the ECG or echocardiogram or genetic factor to predict the PICM after implantation of pacemaker. Not only QRS duration and mechanical strain but also genetic factor could be also investigated to predict the occurrence of PICM before diagnosis fo PICM

+Outcome measures

Primary outcomes

Heart failure diagnosis and treatment [5 years]: Occurrence of heart failure symptom, diagnosis and treatment

Secondary outcomes

Atrial and Ventricular arrhythmia diagnosis, heart failure admisssion and all-caused mortality [5 years]: Occurrence of atrial, ventricular arrhythmia, hear failure admission and all-cause mortality

+Eligibility

Sex: All, ages: 20 Years to any

Inclusion Criteria: mandatory (1 and 2) and optional (3 or 4)

1. Willng to participate in the study and able to sign informed consent
2. Undertaken ECG and echocardiogram including strain before and after device implantation

Exclusion Criteria:

1. Less than 18 years of age
2. Being pregnant or plan to become pregnant
3. Advanced heart failure waiting in heart transplantation
4. Have a life expectancy of less than 1 year

+Locations (3)

Facility	City	Country	Status
Chung-Buk University Hospital	Chungju	South Korea	Recruiting
Chung-Nam University Hospital	Daejeon	South Korea	Recruiting
Chung-Ang University Hospital	Seoul	South Korea	Recruiting

+Publications

Kim JH, Kang KW, Chin JY, Kim TS, Park JH, Choi YJ. Major determinant of the occurrence of pacing-induced cardiomyopathy in complete atrioventricular block: a multicentre, retrospective analysis over a 15-year period in South Korea. BMJ Open. 2018 Feb 8;8(2):e019048. doi: 10.1136/bmjopen-2017-019048. PMID 29439074
Chin JY, Kang KW, Park SH, Choi YJ, Jung KT, Lee S, Youn HJ. Pre-implant global longitudinal strain as an early sign of pacing-induced cardiomyopathy in patients with complete atrioventricular block. Echocardiography. 2021 Feb;38(2):175-182. doi: 10.1111/echo.14942. Epub 2021 Jan 6. PMID 33406280

+Investigators

KI-Woon Kang, MD PhD, Principal investigator, Chung-Ang University Hospital

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