ClinicalTrials.Veeva

Menu

Mri characterIzation of Troponin Elevation After Cardiac Surgery (MITEC)

Civil Hospices of Lyon logo

Civil Hospices of Lyon

Status

Completed

Conditions

Cardiac Surgery
Cardiopulmonary Bypass

Treatments

Biological: Postoperative dosage of released troponin
Procedure: MRI

Study type

Interventional

Funder types

Other

Identifiers

NCT04490785
69HCL20_0020

Details and patient eligibility

About

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.

Enrollment

38 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

38 participants in 1 patient group

patients under aortic surgery with CPB
Experimental group
Description:
Patients under aortic surgery with CPB will have MRI and postoperative dosage of released troponin
Treatment:
Procedure: MRI
Biological: Postoperative dosage of released troponin

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems