Reperfusion InjuryTOMISNCT02812901
Tolerance of Myocardium to Ischemia Injury
A study testing cardiac surgery scheduled in the morning and cardiac surgery scheduled in the afternoon in people with Reperfusion Injury and Myocardial Ischemia, run by University Hospital, Lille at 1 site in France.
Trial summary
This study aims to understand the impact of time-of-the day on human myocardial tolerance to ischemia-reperfusion by exploring atrial myocardium biopsied during cardiac surgery. Patients scheduled for non-urgent cardiac surgery (coronary artery by-pas graft and/or aortic valve replacement) will be assigned to a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Reperfusion Injury, Myocardial Ischemia
- What is being tested?
- cardiac surgery scheduled in the morning and cardiac surgery scheduled in the afternoon
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2016to Jul 2017
- 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
- Patient scheduled for coronary artery bypass graft surgery and/or aortic valve replacement with extra-corporeal circulation
- Patient in sinus rhythm at the time of surgery
- Patient older than 18
- Patient able to understand the information and consent forms
Who cannot join
- Medical history of type 2 diabetes, atrial fibrillation or use of class III anti-arhythmic drug
- left ventricle ejection fraction < 40%
- Pregnancy
- Patient in emergency condition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Morning / Afternoon Variation in Myocardial Ischemia Tolerance
This study aims to understand the impact of time-of-the day on human myocardial tolerance to ischemia-reperfusion by exploring atrial myocardium biopsied during cardiac surgery. Patients scheduled for non-urgent cardiac surgery (coronary artery by-pas graft and/or aortic valve replacement) will be assigned to a morning or an afternoon cardiac surgery based on randomization. Myocardial biopsies will be explored in ex vivo conditions mimicking ischemia-reperfusion.
- Conditions
- Reperfusion Injury, Myocardial Ischemia
- Being tested
- cardiac surgery scheduled in the morning, cardiac surgery scheduled in the afternoon
- Medical subject headings
- Reperfusion Injury, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiac surgery scheduled in the morningProcedure or surgery
cardiac surgery scheduled in the morning
cardiac surgery scheduled in the afternoonProcedure or surgery
cardiac surgery scheduled in the afternoon
| Study group | Role | What they receive |
|---|---|---|
| morning group | Other | cardiac surgery scheduled in the morning Receives: Procedure: cardiac surgery scheduled in the morning |
| afternoon group | Other | cardiac surgery scheduled in the afternoon Receives: Procedure: cardiac surgery scheduled in the afternoon |
What is being measured
The primary outcome is the main question the study is designed to answer.
ischemia reperfusion injury in ex vivo conditions
measurement of hs troponin T released by the myocardium samples in the superfusion solution after ex vivo conditions mimicking ischemia-reperfusion
Measured: the day of the myocardial biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2016 (estimated)
- Study startJan 2016
- Primary completionJul 2017
- Study completionJul 2017
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 Reperfusion InjuryStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Montaigne, MD, PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02812901
- Sponsor's protocol ID
- 2014-56
- Other IDs
- 2015-A00864-45
- Acronym
- TOMIS
- Status last verified
- Aug 2017
- First submitted
- 22 Jun 2016
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Montaigne D, Marechal X, Modine T, Coisne A, Mouton S, Fayad G, Ninni S, Klein C, Ortmans S, Seunes C, Potelle C, Berthier A, Gheeraert C, Piveteau C, Deprez R, Eeckhoute J, Duez H, Lacroix D, Deprez B, Jegou B, Koussa M, Edme JL, Lefebvre P, Staels B. Daytime variation of perioperative myocardial injury in cardiac surgery and its prevention by Rev-Erbalpha antagonism: a single-centre propensity-matched cohort study and a randomised study. Lancet. 2018 Jan 6;391(10115):59-69. doi: 10.1016/S0140-6736(17)32132-3. Epub 2017 Oct 26.
PubMed 29107324
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morning / Afternoon Variation in Myocardial Ischemia Tolerance
- ClinicalTrials.gov ID
- NCT02812901
- Acronym / sponsor ID
- TOMIS / 2014-56
- Conditions
- Reperfusion Injury, Myocardial Ischemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 24 Jun 2016 (estimated)
- 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.
This study aims to understand the impact of time-of-the day on human myocardial tolerance to ischemia-reperfusion by exploring atrial myocardium biopsied during cardiac surgery. Patients scheduled for non-urgent cardiac surgery (coronary artery by-pas graft and/or aortic valve replacement) will be assigned to a morning or an afternoon cardiac surgery based on randomization. Myocardial biopsies will be explored in ex vivo conditions mimicking ischemia-reperfusion.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| morning group | Other | Procedure: cardiac surgery scheduled in the morningcardiac surgery scheduled in the morning |
| afternoon group | Other | Procedure: cardiac surgery scheduled in the afternooncardiac surgery scheduled in the afternoon |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient scheduled for coronary artery bypass graft surgery and/or aortic valve replacement with extra-corporeal circulation
- Patient in sinus rhythm at the time of surgery
- Patient older than 18
- Patient able to understand the information and consent forms
Key exclusion criteria (4 listed)
- Medical history of type 2 diabetes, atrial fibrillation or use of class III anti-arhythmic drug
- left ventricle ejection fraction < 40%
- Pregnancy
- Patient in emergency condition
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 |
|---|---|---|
| cardiac surgery scheduled in the morningcardiac surgery scheduled in the morning | Procedure or surgery | morning group |
| cardiac surgery scheduled in the afternooncardiac surgery scheduled in the afternoon | Procedure or surgery | afternoon group |
Primary outcome
ischemia reperfusion injury in ex vivo conditions
Time frame: the day of the myocardial biopsy
measurement of hs troponin T released by the myocardium samples in the superfusion solution after ex vivo conditions mimicking ischemia-reperfusion
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 5 Feb 2026.
- Results publication: PubMed 29107324Montaigne D, Marechal X, Modine T, Coisne A, Mouton S, Fayad G, Ninni S, Klein C, Ortmans S, Seunes C, Potelle C, Berthier A, Gheeraert C, Piveteau C, Deprez R, Eeckhoute J, Duez H, Lacroix D, Deprez B, Jegou B, Koussa M, Edme JL, Lefebvre P, Staels B. Daytime variation of perioperative myocardial injury in cardiac surgery and its prevention by Rev-Erbalpha antagonism: a single-centre propensity-matched cohort study and a randomised study. Lancet. 2018 Jan 6;391(10115):59-69. doi: 10.1016/S0140-6736(17)32132-3. Epub 2017 Oct 26.
- Individual participant dataSharing planned: Undecided
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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.
David Montaigne, MD, PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cardiac surgery scheduled in the morning and cardiac surgery scheduled in the afternoon in people with Reperfusion Injury and Myocardial Ischemia, run by University Hospital, Lille 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 4 inclusion and 4 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 5 Feb 2026. 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?
ischemia reperfusion injury in ex vivo conditions (time frame: the day of the myocardial biopsy). 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 NCT02812901, 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 5 Feb 2026.