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NCT Number: NCT07351825

CMR Prognostic Markers in Ischemic Heart Disease

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

Beijing, Beijing Municipality, 100037, China

Location status: Recruiting

Location contact

Department of Radiology

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults (≥18 years of age).
  • Patients with ischemic heart disease, including prior or recent myocardial infarction, who underwent clinically indicated cardiac magnetic resonance (CMR) imaging.
  • 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.
  • Availability of baseline clinical data and longitudinal follow-up information.

Exclusion criteria

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

Treatment and study plan

Cardiac magnetic resonance imaging

Diagnostic Test

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 outcomes

  1. Major Adverse Cardiovascular and Cerebrovascular Events

    Time frame: From the date of index clinically indicated cardiac magnetic resonance imaging to the date of first occurrence of a MACCE event, death, or last available clinical follow-up, whichever came first, assessed up to 10 years.

    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. Events are identified through longitudinal clinical follow-up and review of medical records.

Secondary outcomes

  1. Cardiovascular Death

    Time frame: From the date of index clinically indicated cardiac magnetic resonance imaging to the date of cardiovascular death or last available clinical follow-up, whichever came first, assessed up to 10 years.

    Death resulting from cardiovascular causes, including myocardial infarction, heart failure, fatal arrhythmia, or sudden cardiac death, as determined by clinical records and follow-up data.

Study contacts

Contact information is provided by the study sponsor or research team.

Zhaoxin Tian

CONTACT

[email protected]

+86 18309820435

Sponsors and collaborators

Lead sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Other

Collaborators

  • Beijing Natural Science Foundation
  • National Natural Science Foundation of China

Registry information

Official study title

Prognostic Value of Multiparametric Cardiovascular Magnetic Resonance in Patients With Ischemic Heart Disease: A Multicenter Retrospective Cohort Study

Important dates

Study start
2009
Primary completion
2035
Study completion
2035
First posted
Jan 20, 2026
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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