Identifying risk factors for pacemaker-induced cardiomyopathy using ECG and echocardiogram
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.
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 |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | Eulji University Hospital Academic / other |
| Locations | 3 sites (Chungju and 2 other locations) |
| Trial ID | NCT03475498 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients under 18 years old, pregnant, or those with advanced heart failure awaiting transplantation may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Chungju and 2 other locations
- 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 Hosptial, Chung-Ang University College of Medicine
- Study coordinator: Ki-Woon Kang, MD., PhD.
- Email: kwkang0115@gmail.com
- Phone: 81 10 4492 2136
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.