Clinical trial NCT04490785: Mri characterIzation of Troponin Elevation After Cardiac Surgery
Official title: Characterization of Postoperative Myocardial Lesions by Cardiac MRI and Anatomo-biological Correlations With Serum Troponin in Cardiac Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Surgery
Cardiopulmonary Bypass
Keywords: Cardiac surgery
Cardiopulmonary bypass
ischemia reperfusion
Cardiac magnetic resonance imaging
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-07-29
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


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.

Primary outcomes:
measure: correlation between cardiac MRI and the AUC of postoperative plasma released hsTnI.
timeFrame: 5 days
Secondary outcomes:
measure: Relationship between peak serum hsTnI and mass in grams of necrosis on MRI.
timeFrame: 5 days
measure: AUC / serum peak hsTnI relationship and relative size of the necrosis on MRI
timeFrame: 5 days
measure: Relationship of hsTnI levels at 24 hours after aortic unclamping and the mass in grams of necrosis on MRI.
timeFrame: 5 days
measure: AUC / peak serum hsTnI relationship and intensity of edema
timeFrame: 5 days
measure: AUC / hsTnI serum peak relationship and the presence of microvascular obstruction lesions on MRI on postoperative D5
timeFrame: 5 days
measure: Relation of functional and anatomical parameters evaluated by cardiac MRI on postoperative D5.
timeFrame: 5 days
measure: Correlations between clamping time and CEC and the size of the reperfusion lesions visible on MRI on D5 postoperative
timeFrame: 5 days
measure: Exploratory evaluation of the kinetic profile of AUC with the type of lesion found on cardiac MRI (early peak, versus late peak).
timeFrame: 5 days
measure: 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.
timeFrame: 5 days
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital Louis Pradel
Study officials:
References: