Clinical trial NCT03475498: A Major Determinant Focused on the ECG or Echocardiogram for PICM and Its Clinical Outcome (PICM Syndrome)
Official title: 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.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pacemaker Complication
Lead sponsor: Eulji University Hospital
Sponsor class: OTHER
Collaborators: name: Chungnam National University Hospital
name: Chungbuk National University Hospital
name: Dankook University
First posted: 2018-03-23
Enrollment: 500
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will enroll at least 500 device patients from multi-centers in order to identify and assess a determinant of PICM and its clinical outcomes (PICM syndrome)

Brief 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.

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

Eligibility criteria: 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
3. Below preserved left ventricular dysfunction in the echocardiogram
4. Above 15% pacing-rhythm in the device interrogation

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

Primary outcomes:
measure: Heart failure diagnosis and treatment
timeFrame: 5 years
Secondary outcomes:
measure: Atrial and Ventricular arrhythmia diagnosis, heart failure admisssion and all-caused mortality
timeFrame: 5 years
Other outcomes:
Locations:
city: Chungju
country: Korea, Republic of
facility: Chung-Buk University Hospital
city: Daejeon
country: Korea, Republic of
facility: Chung-Nam University Hospital
Study officials:
affiliation: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
name: Hyu Ryung Cho
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.