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

NCT ID: NCT03475498

Last Updated: 2025-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-30

Study Completion Date

2028-02-28

Brief Summary

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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

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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

Conditions

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Pacemaker Complication

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chungnam National University Hospital

OTHER

Sponsor Role collaborator

Chungbuk National University Hospital

OTHER

Sponsor Role collaborator

Dankook University

OTHER

Sponsor Role collaborator

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

OTHER

Sponsor Role collaborator

Eulji University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ki-Woon Kang, MD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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KI-Woon Kang, MD PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Chung-Buk University Hospital

Chungju, , South Korea

Site Status RECRUITING

Chung-Nam University Hospital

Daejeon, , South Korea

Site Status RECRUITING

Chung-Ang University Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Ki-Woon Kang, MD., PhD.

Role: CONTACT

81 10 4492 2136

Hyu Ryung Cho

Role: CONTACT

Facility Contacts

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Deain Lee, M.D.

Role: primary

Jun Hyung Kim, MD. PhD.

Role: primary

Hyu Ryung Cho

Role: primary

82-10-5180-3742

References

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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.

Reference Type BACKGROUND
PMID: 29439074 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7986095 (View on PubMed)

Other Identifiers

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EMC 2018-01-013

Identifier Type: -

Identifier Source: org_study_id

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