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Clinical Trials/NCT04490785
NCT04490785
Completed
N/A

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

Hospices Civils de Lyon1 site in 1 country38 target enrollmentDecember 2, 2020

Overview

Phase
N/A
Intervention
MRI
Conditions
Cardiac Surgery
Sponsor
Hospices Civils de Lyon
Enrollment
38
Locations
1
Primary Endpoint
correlation between cardiac MRI and the AUC of postoperative plasma released hsTnI.
Status
Completed
Last Updated
7 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2, 2020
End Date
January 12, 2023
Last Updated
7 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Arms & Interventions

patients under aortic surgery with CPB

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

Intervention: MRI

patients under aortic surgery with CPB

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

Intervention: Postoperative dosage of released troponin

Outcomes

Primary Outcomes

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

Time Frame: 5 days

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.

Secondary Outcomes

  • 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)
  • 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.(5 days)
  • Relationship between peak serum hsTnI and mass in grams of necrosis on MRI.(5 days)
  • AUC / hsTnI serum peak relationship and the presence of microvascular obstruction lesions 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(5 days)
  • Relation of functional and anatomical parameters evaluated by cardiac MRI on postoperative D5.(5 days)
  • Exploratory evaluation of the kinetic profile of AUC with the type of lesion found on cardiac MRI (early peak, versus late peak).(5 days)

Study Sites (1)

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