Identifying risk factors for pacemaker-induced cardiomyopathy using ECG and echocardiogram
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.
Run by Eulji University Hospital · NCT03475498 · Data updated 2026-11-12
This study is trying to find out what factors can help predict if people with pacemakers will develop heart problems, using heart scans and genetic information.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 20 Years and up |
| Sex | All |
| Enrollment | 1000 (estimated) |
| Sponsor | Eulji University Hospital Academic / other |
| Locations | 3 sites (Chungju and 2 other locations) |
| Status | Recruiting |
| Started | January 30, 2018 |
| Main results expected | February 28, 2027 |
| Study ends | February 28, 2028 |
| Registry record updated | October 2, 2025 |
| Trial ID | NCT03475498 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults who have undergone ECG and echocardiogram assessments before and after pacemaker implantation and are at high risk for PICM.
✕Probably not a fit
Patients under 18 years old, pregnant, or those with advanced heart failure awaiting transplantation may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to identify major determinants that predict the occurrence of pacemaker-induced cardiomyopathy (PICM) by focusing on ECG and echocardiographic parameters, including mechanical strain and genetic factors. Participants with documented high risk of PICM will be prospectively enrolled and followed over a long period to assess the clinical impact of PICM syndrome. The study seeks to enhance the identification of patients at high risk for developing PICM, potentially leading to improved management strategies.
Why it matters
Potential benefit: If successful, this study could lead to better identification and management of patients at risk for pacemaker-induced cardiomyopathy.
How similar studies have gone: While the approach of using ECG and echocardiographic parameters to predict PICM is not widely tested, similar studies have shown promise in identifying cardiac complications in other contexts.
Who can join: the full rules
Show full inclusion / exclusion 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 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
Where it's running
-
Chung-Buk University Hospital
Chungju, South Korea Recruiting -
Chung-Nam University Hospital
Daejeon, South Korea Recruiting -
Chung-Ang University Hospital
Seoul, South Korea Recruiting
Study contacts
- Principal investigator: KI-Woon Kang, MD PhD — Chung-Ang University Hospital
- Study coordinator: Ki-Woon Kang, MD., PhD.
- Email: kwkang0115@gmail.com
- Phone: 81 10 4492 2136
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.