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

NCT03475498 | Recruiting DMC

• 1 other identifier: EMC 2018-01-013
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 3

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.

Conditions

Pacemaker Complication

Outcome Measures

Primary Outcomes (1)

• Heart failure diagnosis and treatment

  Occurrence of heart failure symptom, diagnosis and treatment

  5 years

Secondary Outcomes (1)

• Atrial and Ventricular arrhythmia diagnosis, heart failure admisssion and all-caused mortality

  5 years

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Eulji University Hospital: lead
• Chungnam National University Hospital: collaborator
• Chungbuk National University Hospital: collaborator
• Dankook University: collaborator
• Chung-Ang University Hosptial, Chung-Ang University College of Medicine: collaborator

Study Sites (3)

Chung-Buk University Hospital

Chungju, South Korea

RECRUITING

Chung-Nam University Hospital

Daejeon, South Korea

RECRUITING

Chung-Ang University Hospital

Seoul, South Korea

RECRUITING

Related Publications (2)

• 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 BACKGROUND

• 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.

  PMID: 7986095 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Investigators exam to identify a biomarker (ECG or Echocardiogram parameter or genetic factor) as a determinant for occurrence of PICM

Study Officials

• KI-Woon Kang, MD PhD

  Chung-Ang University Hosptial, Chung-Ang University College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ki-Woon Kang, MD., PhD.

CONTACT

81 10 4492 2136; kwkang0115@gmail.com

Hyu Ryung Cho

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 18, 2018
• First Posted: March 23, 2018
• Study Start: January 30, 2018
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2028
• Last Updated: October 2, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (3)