Cardiac SurgeryMITECNCT04490785
Mri characterIzation of Troponin Elevation After Cardiac Surgery
A study testing MRI and Postoperative dosage of released troponin in people with Cardiac Surgery and Cardiopulmonary Bypass, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery, Cardiopulmonary Bypass
- What is being tested?
- MRI and Postoperative dosage of released troponin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteFrance
- Study dates
- 2 Dec 2020to 12 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Characterization of Postoperative Myocardial Lesions by Cardiac MRI and Anatomo-biological Correlations With Serum Troponin in Cardiac Surgery.
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.
- Conditions
- Cardiac Surgery, Cardiopulmonary Bypass
- Being tested
- MRI, Postoperative dosage of released troponin
- Keywords
- Cardiac surgery, Cardiopulmonary bypass, ischemia reperfusion, Cardiac magnetic resonance imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIProcedure or surgery
1 MRI 5 days after surgery (-1; +4 days), with intravenous administration of gadolinium
Postoperative dosage of released troponinBiological
Dosage of troponin I Hs H4, H8, H12, H24, H48, and H72 after the aortic cross-unclamping.
| Study group | Role | What they receive |
|---|---|---|
| patients under aortic surgery with CPB | Experimental | Patients under aortic surgery with CPB will have MRI and postoperative dosage of released troponin Receives: Procedure: MRI; Biological: Postoperative dosage of released troponin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 days
Secondary outcomes (9)
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.
Measured: 5 days
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.
Measured: 5 days
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.
Measured: 5 days
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
Measured: 5 days
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.
Measured: 5 days
Relation of functional and anatomical parameters evaluated by cardiac MRI on postoperative D5.
Tele-diastolic volume / ventricular mass, LVEF on MRI on postoperative D5.
Measured: 5 days
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.
Measured: 5 days
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.
Measured: 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.
Correlation between the right ventricle in 4 cavities and small axis (2 differents measures) on MRI on D5 postoperative.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2020
- Study start2 Dec 2020
- Primary completion12 Jan 2023
- Study completion12 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04490785
- Sponsor's protocol ID
- 69HCL20_0020
- Acronym
- MITEC
- Status last verified
- Sep 2025
- First submitted
- 24 Jul 2020
- Last updated
- 10 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fellahi JL, Ferraris A, Chiari P, Varillon Y, De Bourguignon C, Mewton N. High-Sensitivity Troponin I Release After Aortic Surgery: A Mechanistic Approach with Contrast-Enhanced Magnetic Resonance Imaging (the MITEC Study). Anesth Analg. 2025 Jan 1;140(1):228-230. doi: 10.1213/ANE.0000000000007165. Epub 2024 Oct 15. No abstract available.
PubMed 39466631
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Postoperative Myocardial Lesions by Cardiac MRI and Anatomo-biological Correlations With Serum Troponin in Cardiac Surgery.
- ClinicalTrials.gov ID
- NCT04490785
- Acronym / sponsor ID
- MITEC / 69HCL20_0020
- Conditions
- Cardiac Surgery, Cardiopulmonary Bypass
- Keywords
- Cardiac surgery, Cardiopulmonary bypass, ischemia reperfusion, Cardiac magnetic resonance imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 2 Dec 2020 (actual)
- Primary completion
- 12 Jan 2023 (actual)
- Study completion
- 12 Jan 2023 (actual)
- First posted
- 29 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients under aortic surgery with CPB | Experimental | Procedure: MRI, Biological: Postoperative dosage of released troponinPatients under aortic surgery with CPB will have MRI and postoperative dosage of released troponin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (13 listed)
- 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%)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI1 MRI 5 days after surgery (-1; +4 days), with intravenous administration of gadolinium | Procedure or surgery | patients under aortic surgery with CPB |
| Postoperative dosage of released troponinDosage of troponin I Hs H4, H8, H12, H24, H48, and H72 after the aortic cross-unclamping. | Biological | patients under aortic surgery with CPB |
Primary outcome
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.
9 secondary outcomes
Relationship between peak serum hsTnI and mass in grams of necrosis on MRI.
Time frame: 5 days
AUC / serum peak hsTnI relationship and relative size of the necrosis on MRI
Time frame: 5 days
Relationship of hsTnI levels at 24 hours after aortic unclamping and the mass in grams of necrosis on MRI.
Time frame: 5 days
AUC / peak serum hsTnI relationship and intensity of edema
Time frame: 5 days
AUC / hsTnI serum peak relationship and the presence of microvascular obstruction lesions on MRI on postoperative D5
Time frame: 5 days
Relation of functional and anatomical parameters evaluated by cardiac MRI on postoperative D5.
Time frame: 5 days
Correlations between clamping time and CEC and the size of the reperfusion lesions visible on MRI on D5 postoperative
Time frame: 5 days
Exploratory evaluation of the kinetic profile of AUC with the type of lesion found on cardiac MRI (early peak, versus late peak).
Time frame: 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.
Time frame: 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Results publication: PubMed 39466631Fellahi JL, Ferraris A, Chiari P, Varillon Y, De Bourguignon C, Mewton N. High-Sensitivity Troponin I Release After Aortic Surgery: A Mechanistic Approach with Contrast-Enhanced Magnetic Resonance Imaging (the MITEC Study). Anesth Analg. 2025 Jan 1;140(1):228-230. doi: 10.1213/ANE.0000000000007165. Epub 2024 Oct 15. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI and Postoperative dosage of released troponin in people with Cardiac Surgery and Cardiopulmonary Bypass, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
correlation between cardiac MRI and the AUC of postoperative plasma released hsTnI. (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04490785, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025.