Mri characterIzation of Troponin Elevation After Cardiac Surgery

NCT ID: NCT04490785

Last Updated: 2025-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-02
• Study Completion Date: 2023-01-12

Brief Summary

Cardiac surgery under cardiopulmonary bypass (CPB) induces myocardial ischemia-reperfusion injury. This myocardial attack is a well-identified independent prognostic factor of postoperative morbidity and mortality. The quantification of these myocardial lesions by the postoperative plasma release of troponin has proven its diagnostic and prognostic value.

Cardiac magnetic resonance imaging (MRI) can accurately measure and characterize the size of myocardial lesions. These lesions are associated with a poor prognosis. MRI can also characterize myocardial edema secondary to ischemia-reperfusion which has not yet been studied in the context of CPB. It is therefore necessary, in a mechanistic approach, to quantify the respective share of necrosis, edema and reperfusion lesions during cardiac surgery under CPB in order to better understand these phenomena and to propose effective strategies for the prevention of these myocardial lesions.the relationship between the postoperative release of troponin and the amount of myocardial necrosis and edema measured by cardiac MRI will be assessed.The hypothesis is to demonstrate a positive correlation between imaging and biology in order to better understand the perioperative myocardial lesion processes.

This is an interventional study prospective, exploratory, in cardiac imaging, non-comparative and single-center, including 30 patients.

Conditions

Cardiac Surgery; Cardiopulmonary Bypass

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

patients under aortic surgery with CPB

Patients under aortic surgery with CPB will have MRI and postoperative dosage of released troponin

Group Type: EXPERIMENTAL

MRI

Intervention Type: PROCEDURE

1 MRI 5 days after surgery (-1; +4 days), with intravenous administration of gadolinium

Postoperative dosage of released troponin

Intervention Type: BIOLOGICAL

Dosage of troponin I Hs H4, H8, H12, H24, H48, and H72 after the aortic cross-unclamping.

Interventions

MRI

1 MRI 5 days after surgery (-1; +4 days), with intravenous administration of gadolinium

Intervention Type: PROCEDURE

Postoperative dosage of released troponin

Dosage of troponin I Hs H4, H8, H12, H24, H48, and H72 after the aortic cross-unclamping.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years old
• Aortic valve surgery with CEC: aortic valve replacement, Bentall, Tirone-David, Wheat with foreseeable clamping time of at least 40 minutes.
• Informed consent signed

Exclusion Criteria

• Emergency surgery
• Other unconventional heart surgery
• Aorto-coronary bypass associated with surgery
• History of myocardial infarction or severe coronary artery disease, non-valvular hypertrophic cardiomyopathy (MHC) (primary MHC type, Amyloidosis) and myocarditis
• Preoperative alteration of systolic function of the left ventricle (LVEF <40%)
• Presence of a contraindication to cardiac MRI (claustrophobia, pacemaker or cardiac defibrillator, metallic body, hypersensitivity to gadolinium)
• Patients with a glomerular filtration rate (GFR) <30 ml / min
• Patients with permanent atrial fibrillation (ACFA) cardiac arrhythmia
• Patients treated with anthracyclines
• Pregnant and / or lactating woman
• Patient under legal protection
• Patient not benefiting from a social security system
• Patient participating in another clinical study that may interfere with the results of this study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpital Louis Pradel

Bron, , France

Countries

France

References

Fellahi JL, Ferraris A, Chiari P, Varillon Y, De Bourguignon C, Mewton N. High-Sensitivity Troponin I Release After Aortic Surgery: A Mechanistic Approach with Contrast-Enhanced Magnetic Resonance Imaging (the MITEC Study). Anesth Analg. 2025 Jan 1;140(1):228-230. doi: 10.1213/ANE.0000000000007165. Epub 2024 Oct 15. No abstract available.

Reference Type: BACKGROUND

PMID: 39466631 (View on PubMed)

Other Identifiers

69HCL20_0020

Identifier Type: -

Identifier Source: org_study_id