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

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Pacemaker Complication

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

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Ki-Woon Kang, MD., PhD.; Phone Number: 81 10 4492 2136; Email: kwkang0115@gmail.com
• Study Contact Backup: Name: Hyu Ryung Cho

Study Locations

• South Korea
  • Chungju, South Korea
    • Recruiting
    • Chung-Buk University Hospital
    • Contact: Deain Lee, M.D.
  • Daejeon, South Korea
    • Recruiting
    • Chung-Nam University Hospital
    • Contact: Jun Hyung Kim, MD. PhD.
  • Seoul, South Korea
    • Recruiting
    • Chung-Ang University Hospital
    • Contact: Hyu Ryung Cho; Phone Number: 82-10-5180-3742; Email: whgbfud@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study will enroll at least 1000 device patients from multi-centers in order to identify and assess a determinant of PICM and its clinical outcomes (PICM syndrome)

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart failure diagnosis and treatment	Occurrence of heart failure symptom, diagnosis and treatment	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Atrial and Ventricular arrhythmia diagnosis, heart failure admisssion and all-caused mortality	Occurrence of atrial, ventricular arrhythmia, hear failure admission and all-cause mortality	5 years

Collaborators and Investigators

• Sponsor: Eulji University Hospital
• Collaborators: Chung-Ang University Hosptial, Chung-Ang University College of Medicine; Chungnam National University Hospital; Chungbuk National University Hospital; Dankook University
• Investigators: Principal Investigator: KI-Woon Kang, MD PhD, Chung-Ang University Hosptial, Chung-Ang University College of Medicine

Publications and helpful links

General 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.
• Phung CD, Ezieme JA, Turrens JF. Hydrogen peroxide metabolism in skeletal muscle mitochondria. Arch Biochem Biophys. 1994 Dec;315(2):479-82. doi: 10.1006/abbi.1994.1528.

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2018
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2028

Study Registration Dates

• First Submitted: March 18, 2018
• First Submitted That Met QC Criteria: March 18, 2018
• First Posted (Actual): March 23, 2018

Study Record Updates

• Last Update Posted (Estimated): October 2, 2025
• Last Update Submitted That Met QC Criteria: September 28, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: EMC 2018-01-013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No