Mri characterIzation of Troponin Elevation After Cardiac Surgery

NCT04490785 | Completed

• 1 other identifier: 69HCL20_0020
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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

Keywords

Cardiac surgery; Cardiopulmonary bypass; ischemia reperfusion; Cardiac magnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

• correlation between cardiac MRI and the AUC of postoperative plasma released hsTnI.

  Correlation between the AUC of plasma hsTnI levels measured during the first 72 hours postoperatively (sequential basal assays then 4, 8, 12, 24, 48 and 72 hours after aortic unclamping) and the mass in grams of myocardial necrosis measured by the late enhancement in cardiac MRI on D5 postoperative. Correlations between MRI anatomical data and biological or ultrasound data will be assessed with the Pearson or Spearman correlation coefficient according to the distribution of variables and linear regression.

  5 days

Secondary Outcomes (9)

• Relationship between peak serum hsTnI and mass in grams of necrosis on MRI.

  5 days

• AUC / serum peak hsTnI relationship and relative size of the necrosis on MRI

  5 days

• Relationship of hsTnI levels at 24 hours after aortic unclamping and the mass in grams of necrosis on MRI.

  5 days

• AUC / peak serum hsTnI relationship and intensity of edema

  5 days

• AUC / hsTnI serum peak relationship and the presence of microvascular obstruction lesions on MRI on postoperative D5

  5 days

Study Arms (1)

patients under aortic surgery with CPB

EXPERIMENTAL

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

Procedure: MRI; Biological: Postoperative dosage of released troponin

Interventions

MRI PROCEDURE

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

patients under aortic surgery with CPB

Postoperative dosage of released troponin BIOLOGICAL

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

patients under aortic surgery with CPB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hôpital Louis Pradel

Bron, 69500, France

Location

Related Publications (1)

• 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.

  PMID: 39466631 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2020
• First Posted: July 29, 2020
• Study Start: December 2, 2020
• Primary Completion: January 12, 2023
• Study Completion: January 12, 2023
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)