CMR-Based Prognostic Study in Patients With Cardiac Implantable Electronic Devices

Chinese Academy of Medical Sciences, Fuwai Hospital

Status: Enrolling

Conditions: Arrhythmias

Treatments: Other: Cardiac Magnetic Resonance Imaging

Study type: Observational

Funder types: Other

Identifiers

NCT07336225

CMR-CIED

Details and patient eligibility

About

Cardiac implantable electronic devices (CIEDs) are widely used to treat patients with heart failure, malignant arrhythmias, and other conditions. However, accurately identifying suitable candidates for CIED implantation remains a clinical challenge. Cardiovascular magnetic resonance imaging (CMR) provides a comprehensive assessment of cardiac structure, function, and tissue characteristics, facilitating evaluation of the myocardial substrate for arrhythmias. This study aims to evaluate the prognostic value of multiparametric CMR-derived imaging markers in CIED patients through preoperative CMR examinations. Imaging parameters of interest include structural-functional indices, myocardial strain, late gadolinium enhancement, entropy, and T1 and T2 mapping. Long-term clinical outcomes will be obtained from existing medical records and follow-up. The primary endpoint is sudden cardiac death (SCD) or SCD-equivalent events, defined as SCD, resuscitated cardiac arrest, sustained ventricular tachycardia or ventricular fibrillation, or appropriate ICD therapy. Secondary endpoints include all-cause mortality or heart failure rehospitalization. This study aims to elucidate the role of CMR in assessing CIED treatment indications and long-term risk stratification, thereby helping to optimize CIED implantation decisions.

Enrollment: 1,500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adult patients (≥18 years old).
2. Patients with guideline-based indications for cardiac implantable electronic device (CIED) therapy, including pacemaker, implantable cardioverter-defibrillator, or cardiac resynchronization therapy.
3. Patients who underwent cardiovascular magnetic resonance (CMR) imaging as part of routine clinical evaluation prior to CIED implantation or consideration of CIED therapy.

Exclusion criteria

1. Patients younger than 18 years of age.
2. Patients with non-diagnostic or poor-quality CMR images that preclude reliable image analysis.
3. Patients with incomplete key clinical data or missing follow-up information for primary outcome assessment.
4. Patients with prior heart transplantation or implantation of ventricular assist devices before CMR examination.
5. Patients with congenital heart disease requiring surgical correction.

Trial design

1,500 participants in 1 patient group

Cardiac Implantable Electronic Device Cohort

Treatment:

Other: Cardiac Magnetic Resonance Imaging