CMR-Based Prognostic Study in Patients With Cardiac Implantable Electronic Devices
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cardiac Magnetic Resonance Imaging.
- Who it may be relevant to
- Registry conditions: Arrhythmias. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prognostic Value of Cardiovascular Magnetic Resonance in Patients With Cardiac Implantable Electronic Devices
Overview
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.
Interventions
- Other 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.
Primary outcome measures
- A composite of sudden cardiac death (SCD) and SCD-equivalent events [Time frame: 1-10 years]
Eligibility criteria
Inclusion criteria
- Adult patients (≥18 years old).
- Patients with guideline-based indications for cardiac implantable electronic device (CIED) therapy, including pacemaker, implantable cardioverter-defibrillator, or cardiac resynchronization therapy.
- 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
- Patients younger than 18 years of age.
- Patients with non-diagnostic or poor-quality CMR images that preclude reliable image analysis.
- Patients with incomplete key clinical data or missing follow-up information for primary outcome assessment.
- Patients with prior heart transplantation or implantation of ventricular assist devices before CMR examination.
- Patients with congenital heart disease requiring surgical correction.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Center not named — Beijing
Identifiers
NCT: NCT07336225 · CMR-CIED