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

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

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-01

Study Completion Date

2040-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Arrhythmias

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Cardiac Implantable Electronic Device Cohort

Cardiac Magnetic Resonance Imaging

Intervention Type OTHER

Cardiac magnetic resonance imaging performed as part of routine clinical care. Imaging data are used for observational research analyses only, without altering clinical management.

Interventions

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Cardiac Magnetic Resonance Imaging

Cardiac magnetic resonance imaging performed as part of routine clinical care. Imaging data are used for observational research analyses only, without altering clinical management.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No