CMR Prognostic Markers in Ischemic Heart Disease

Chinese Academy of Medical Sciences, Fuwai Hospital

Status: Enrolling

Conditions: Myocardial Infarction (MI); Ischemic Heart Disease (IHD)

Treatments: Diagnostic Test: Cardiac Magnetic Resonance Imaging

Study type: Observational

Funder types: Other

Identifiers

NCT07351825

7242110 (Other Grant/Funding Number)

CMR-IHD

82471973 (Other Grant/Funding Number)

2022-GSP-QZ-5 (Other Grant/Funding Number)

Details and patient eligibility

About

Ischemic heart disease (IHD) remains a leading cause of morbidity and mortality worldwide. Accurate risk stratification is essential for guiding clinical management and improving long-term outcomes in patients with ischemic myocardial injury.

Cardiovascular magnetic resonance (CMR) imaging provides comprehensive assessment of myocardial structure, function, and tissue characteristics, enabling detailed evaluation of ischemic injury and its consequences.

This multicenter, retrospective observational study aims to investigate the prognostic value of multiparametric CMR-derived imaging markers in patients with ischemic heart disease who underwent clinically indicated CMR examinations. Imaging parameters of interest include late gadolinium enhancement (LGE), infarct size, microvascular obstruction (MVO), left ventricular and left atrial strain, and native T1 and T2 mapping values.

Long-term clinical outcomes will be obtained from existing medical records. The primary outcome is major adverse cardiovascular and cerebrovascular events (MACCE), and secondary outcome is cardiovascular death. This study seeks to clarify the role of CMR in long-term risk stratification of patients with ischemic heart disease.

Full description

This is a multicenter, retrospective observational cohort study based on existing clinical and cardiovascular magnetic resonance (CMR) imaging data. Patients with ischemic heart disease who underwent clinically indicated CMR examinations will be included. Data are derived from multiple centers and span an extended time period, reflecting real-world clinical practice.

CMR examinations were performed as part of routine clinical care. Imaging parameters to be analyzed include late gadolinium enhancement (LGE) for assessment of myocardial scar and ischemic injury, infarct size, presence of microvascular obstruction (MVO), left ventricular and left atrial strain parameters, and native T1 and T2 mapping values when available. Image analysis will be conducted using standardized post-processing methods.

Demographic characteristics, cardiovascular risk factors, treatment strategies, and follow-up data will be collected retrospectively from institutional databases and medical records. The primary outcome of interest is major adverse cardiovascular and cerebrovascular events (MACCE), defined as a composite of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, hospitalization for heart failure, and unplanned coronary revascularization. The secondary outcome is cardiovascular death.

The primary objective of this study is to evaluate the association between multiparametric CMR-derived imaging markers and long-term clinical outcomes in patients with ischemic heart disease. Secondary objectives include exploring the incremental prognostic value of CMR parameters beyond conventional clinical risk factors and assessing their role in improving individualized risk stratification.

Advanced image analysis techniques, including radiomics and machine learning-based methods, may be applied to CMR images to explore imaging-derived features associated with long-term clinical outcomes.

Enrollment: 1,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adults (≥18 years of age).
2. Patients with ischemic heart disease, including prior or recent myocardial infarction, who underwent clinically indicated cardiac magnetic resonance (CMR) imaging.
3. Availability of analyzable CMR images, including but not limited to cine imaging, late gadolinium enhancement (LGE), and parametric mapping sequences (T1 and/or T2 mapping), as applicable.
4. Availability of baseline clinical data and longitudinal follow-up information.

Exclusion criteria

1. Poor image quality or incomplete CMR data precluding quantitative analysis.
2. Presence of other severe comorbid conditions expected to significantly affect survival or clinical outcomes.
3. Missing key clinical outcome data during follow-up.

Trial design

1,000 participants in 1 patient group

Ischemic Heart Disease Cohort

Description:

Adult patients with ischemic heart disease who underwent clinically indicated cardiac magnetic resonance imaging. Imaging, clinical, and follow-up data are collected for observational analyses, including quantitative imaging, outcome assessment, and exploratory modeling.

Treatment:

Diagnostic Test: Cardiac Magnetic Resonance Imaging