Mri characterIzation of Troponin Elevation After Cardiac Surgery
Keywords
Abstract
Dates
Last Verified: | 06/30/2020 |
First Submitted: | 07/23/2020 |
Estimated Enrollment Submitted: | 07/23/2020 |
First Posted: | 07/28/2020 |
Last Update Submitted: | 07/23/2020 |
Last Update Posted: | 07/28/2020 |
Actual Study Start Date: | 08/31/2020 |
Estimated Primary Completion Date: | 02/28/2022 |
Estimated Study Completion Date: | 02/28/2022 |
Condition or disease
Intervention/treatment
Procedure: patients under aortic surgery with CPB
Biological: patients under aortic surgery with CPB
Phase
Arm Groups
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: patients under aortic surgery with CPB 1 MRI 5 days after surgery (-1; +4 days), with intravenous administration of gadolinium |
Eligibility Criteria
Ages Eligible for Study | 18 Years To 18 Years |
Sexes Eligible for Study | All |
Accepts Healthy Volunteers | Yes |
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. |
Outcome
Primary Outcome Measures
1. correlation between cardiac MRI and the AUC of postoperative plasma released hsTnI. [5 days]
Secondary Outcome Measures
1. Relationship between peak serum hsTnI and mass in grams of necrosis on MRI. [5 days]
2. AUC / serum peak hsTnI relationship and relative size of the necrosis on MRI [5 days]
3. Relationship of hsTnI levels at 24 hours after aortic unclamping and the mass in grams of necrosis on MRI. [5 days]
4. AUC / peak serum hsTnI relationship and intensity of edema [5 days]
5. AUC / hsTnI serum peak relationship and the presence of microvascular obstruction lesions on MRI on postoperative D5 [5 days]
6. Relation of functional and anatomical parameters evaluated by cardiac MRI on postoperative D5. [5 days]
7. Correlations between clamping time and CEC and the size of the reperfusion lesions visible on MRI on D5 postoperative [5 days]
8. Exploratory evaluation of the kinetic profile of AUC with the type of lesion found on cardiac MRI (early peak, versus late peak). [5 days]
9. 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]