NCT07336225 CMR-Based Prognostic Study in Patients With Cardiac Implantable Electronic Devices
| NCT ID | NCT07336225 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chinese Academy of Medical Sciences, Fuwai Hospital |
| Condition | Arrhythmias |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,500 participants |
| Start Date | 2010-01-01 |
| Primary Completion | 2035-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,500 participants in total. It began in 2010-01-01 with a primary completion date of 2035-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07336225 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Arrhythmias. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07336225 currently recruiting?
Yes, NCT07336225 is actively recruiting participants. Contact the research team at lxq010126@163.com for enrollment information.
Where is the NCT07336225 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07336225 clinical trial?
NCT07336225 is sponsored by Chinese Academy of Medical Sciences, Fuwai Hospital. The trial plans to enroll 1,500 participants.