Mri characterIzation of Troponin Elevation After Cardiac Surgery

Cardiac Surgery Clinical Trial

— MITEC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04490785
• Other study ID #: 69HCL20_0020
• Status: Completed
• Phase: N/A
• Start date: December 2, 2020
• Est. completion date: January 12, 2023

Study information

• Verified date: March 2023
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: January 12, 2023
• Est. primary completion date: January 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Surgery
• Cardiopulmonary Bypass

Intervention

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.

Locations

Country	Name	City	State
France	Hôpital Louis Pradel	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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