NCT07351825

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
117mo left

Started Jan 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress64%
Jan 2009Dec 2035

Study Start

First participant enrolled

January 1, 2009

Completed
17 years until next milestone

First Submitted

Initial submission to the registry

December 29, 2025

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 20, 2026

Completed
9.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2035

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2035

Last Updated

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

26.9 years

First QC Date

December 29, 2025

Last Update Submit

January 11, 2026

Conditions

Keywords

Ischemic heart diseaseCardiovascular magnetic resonanceLate gadolinium enhancementRadiomicsRisk stratificationPrognosis

Outcome Measures

Primary Outcomes (1)

  • Major Adverse Cardiovascular and Cerebrovascular Events

    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.

    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.

Secondary Outcomes (1)

  • Cardiovascular Death

    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.

Study Arms (1)

Ischemic Heart Disease Cohort

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.

Diagnostic Test: Cardiac Magnetic Resonance Imaging

Interventions

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

Ischemic Heart Disease Cohort

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This observational study includes adult patients with ischemic heart disease who underwent clinically indicated cardiac magnetic resonance imaging as part of routine clinical care at participating centers. The study population represents a real-world cohort with a broad spectrum of ischemic heart disease, including myocardial infarction, and is characterized by comprehensive CMR imaging data, detailed clinical information, and long-term follow-up for cardiovascular outcomes.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Beijing, Beijing Municipality, 100037, China

RECRUITING

MeSH Terms

Conditions

Myocardial IschemiaMyocardial Infarction

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Director, Department of Cardiovascular Magnetic Resonance Imaging

Study Record Dates

First Submitted

December 29, 2025

First Posted

January 20, 2026

Study Start

January 1, 2009

Primary Completion (Estimated)

December 1, 2035

Study Completion (Estimated)

December 1, 2035

Last Updated

January 20, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

De-identified individual participant data, including imaging-derived parameters and relevant clinical variables, will be available upon reasonable request. Data sharing will be considered after publication of the primary results and will require approval by the study investigators and the institutional ethics committee, with a data use agreement in place.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
The IPD and supporting documents will be available beginning 6 months after publication of the primary results and will remain available for a minimum of 5 years. Access will be granted upon reasonable request, subject to approval by the study investigators and the institutional ethics committee, and execution of a data use agreement.
Access Criteria
Access to individual participant data (IPD) and supporting documents will be granted to qualified researchers with a legitimate scientific proposal. Requests will be reviewed by the study investigators and subject to approval by the institutional ethics committee. Approved users will be required to sign a data use agreement. Data will be shared in a de-identified format via secure data transfer methods. Proposals should be submitted by email to the corresponding investigator.

Locations