NCT07650487

Brief Summary

Perioperative myocardial injury (PMI) following coronary artery bypass grafting (CABG) is associated with postoperative morbidity, mortality, and long-term outcomes. High-sensitivity troponin assays and cardiac MRI offer reliable diagnostic tools for PMI, but evidence regarding optimal diagnostic thresholds and perioperative imaging strategy is limited. This prospective clinical study aims to determine the incidence of perioperative myocardial injury using multimodal assessments including high-sensitivity troponin, electrocardiogram, echocardiography, cardiac MRI, and perioperative cardiovascular events.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
12mo left

Started Jul 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress8%
Jul 2026Jul 2027

First Submitted

Initial submission to the registry

June 10, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 16, 2026

Completed
15 days until next milestone

Study Start

First participant enrolled

July 1, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2027

Last Updated

June 16, 2026

Status Verified

June 1, 2026

Enrollment Period

12 months

First QC Date

June 10, 2026

Last Update Submit

June 10, 2026

Conditions

Keywords

Perioperative Myocardial InjuryCoronary Artery Bypass GraftingCardiac MRIhs-TroponinCoronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • Incidence of Perioperative Myocardial Injury (PMI)

    Perioperative myocardial injury defined by elevation of high-sensitivity troponin above the 99th percentile upper reference limit together with new myocardial injury detected by cardiac MRI or supportive ECG/echocardiographic changes. PMI is assessed using laboratory testing and imaging performed preoperatively, within 48 hours post-CABG, and at discharge.

    Within 48 hours post-CABG

Study Arms (1)

CABG Patients

A prospective cohort of adult patients undergoing elective or urgent coronary artery bypass grafting. Participants will undergo perioperative evaluation including hs-troponin testing, ECG, echocardiography, and cardiac MRI to assess perioperative myocardial injury.

Diagnostic Test: High-Sensitivity TroponinDiagnostic Test: Cardiac MRI

Interventions

High-sensitivity troponin levels are measured preoperatively, predischarge, and at 6-month follow-up to assess perioperative myocardial injury.

CABG Patients
Cardiac MRIDIAGNOSTIC_TEST

A diagnostic assessment panel including high-sensitivity troponin testing, electrocardiography, echocardiography, and cardiac magnetic resonance imaging performed during the perioperative period.

CABG Patients

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult patients diagnosed with unstable angina and scheduled to undergo isolated coronary artery bypass grafting (CABG) at the Second Hospital of Jilin University. All participants receive routine perioperative clinical evaluations. The study includes patients aged 21 years or older who provide written informed consent and have had no major cardiovascular events within the previous 6 months. Patients with severe organ dysfunction, pregnancy, or contraindications to cardiac MRI are excluded.

You may qualify if:

  • Age ≥ 21 years
  • Undergoing CABG for unstable angina
  • Able to provide written informed consent
  • No major cardiovascular event in the prior 6 months

You may not qualify if:

  • Significant hepatic, renal, or other major organ dysfunction
  • Pregnancy or breastfeeding
  • Withdrawal during the study
  • Contraindication to cardiac MRI (metal implants, claustrophobia, etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the Second Hospital of Jilin University

Changchun, Jilin, 130000, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Residual clinical samples collected as part of routine perioperative care may be used for measuring high-sensitivity troponin and other laboratory indicators. No samples will be stored long-term and no DNA will be collected.

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 10, 2026

First Posted

June 16, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

July 30, 2027

Last Updated

June 16, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations