Mri characterIzation of Troponin Elevation After Cardiac Surgery (MITEC)

Characterization of Postoperative Myocardial Lesions by Cardiac MRI and Anatomo-biological Correlations With Serum Troponin in Cardiac Surgery.

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.

Study Overview

• Status: Completed
• Conditions: Cardiac Surgery; Cardiopulmonary Bypass
• Intervention / Treatment: Procedure: MRI; Biological: Postoperative dosage of released troponin

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Arnaud FERRARIS; Phone Number: +33 4 72 35 75 95; Email: arnaud.ferraris@chu-lyon.fr
• Study Contact Backup: Name: Yvonne VARILLON; Phone Number: +33 4 72 35 69 64; Email: yvonne.varillon@chu-lyon.fr

Study Locations

• France
  • Bron, France, 69500
    • Hopital Louis Pradel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: patients under aortic surgery with CPB; Patients under aortic surgery with CPB will have MRI and postoperative dosage of released troponin	Procedure: MRI; 1 MRI 5 days after surgery (-1; +4 days), with intravenous administration of gadolinium; Biological: Postoperative dosage of released troponin; Dosage of troponin I Hs H4, H8, H12, H24, H48, and H72 after the aortic cross-unclamping.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relationship between peak serum hsTnI and mass in grams of necrosis on MRI.	Correlation between highest serum value recorded for each patient within 72 hours and the mass in grams of myocardial necrosis measured by the late enhancement in cardiac MRI on D5 postoperative.	5 days
AUC / serum peak hsTnI relationship and relative size of the necrosis on MRI	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 percentage of left ventricular mass. Correlation between highest serum value recorded for each patient within 72 hours and percentage of left ventricular mass.	5 days
Relationship of hsTnI levels at 24 hours after aortic unclamping and the mass in grams of necrosis on MRI.	Correlation between the AUC of plasma hsTnI levels measured at 24 hours after aortic unclamping and the mass in grams of myocardial necrosis measured by the late enhancement in cardiac MRI on D5 postoperative.	5 days
AUC / peak serum hsTnI relationship and intensity of edema	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 intensity of edema at MRI. Correlation between highest serum value recorded for each patient within 72 hours and intensity of edema at MRI	5 days
AUC / hsTnI serum peak relationship and the presence of microvascular obstruction lesions on MRI on postoperative D5	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 presence of microvascular obstruction lesions on MRI on postoperative D5. Correlation between highest serum value recorded for each patient within 72 hours and the presence of microvascular obstruction lesions on MRI on postoperative D5.	5 days
Relation of functional and anatomical parameters evaluated by cardiac MRI on postoperative D5.	Tele-diastolic volume / ventricular mass, LVEF on MRI on postoperative D5.	5 days
Correlations between clamping time and CEC and the size of the reperfusion lesions visible on MRI on D5 postoperative	Correlation between clamping time and the size of the reperfusion lesions visible on MRI on D5 postoperative. Correlation between CEC time and the size of the reperfusion lesions visible on MRI on D5 postoperative.	5 days
Exploratory evaluation of the kinetic profile of AUC with the type of lesion found on cardiac MRI (early peak, versus late peak).	Correlation between the kinetic profile of AUC and the type of lesion found on MRI on D5 postoperative.	5 days
Relation of functional and anatomical parameters of the right ventricle in 4 cavities and small axis (tele-diastolic volume, FEVD) evaluated by cardiac MRI on D5 postoperative.	Correlation between the right ventricle in 4 cavities and small axis (2 differents measures) on MRI on D5 postoperative.	5 days

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2020
• Primary Completion (Actual): January 12, 2023
• Study Completion (Actual): January 12, 2023

Study Registration Dates

• First Submitted: July 24, 2020
• First Submitted That Met QC Criteria: July 24, 2020
• First Posted (Actual): July 29, 2020

Study Record Updates

• Last Update Posted (Estimate): March 7, 2023
• Last Update Submitted That Met QC Criteria: March 6, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Cardiac surgery; Cardiopulmonary bypass; Cardiac magnetic resonance imaging; ischemia reperfusion
• Other Study ID Numbers: 69HCL20_0020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No