Myocardial IschemiaMINI-SEVONCT02551328
Preconditioning With Sevoflurane and Propofol in Patients Undergoing Minimally Invasive Mitral Valve Surgery
An observational study of Myocardial Ischemia, run by Fondazione Toscana Gabriele Monasterio at 1 site in Italy.
Trial summary
The main aim of this study is to compare markers of cardiac injury (Troponin I), inflammatory response and platelets function during minimally invasive mitral valve repair or replacement (MIMV) via right mini-thoracotomy in two standard anaesthetic regimes (sevo \propofol) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Ischemia
- What is being tested?
- sevofluorane
- Type of treatment
- Injection or infusion
- How many people
- 48 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2015to Sep 2016
- Phase
- Observational
- 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
Study population: Age>=18 Pt undergoing elective (or urgent) first-time minimal invasive mitral valve surgery Pt will have to sign informed consent
Who may be able to join
- Age ≥18
- Patients undergoing elective (or urgent) first-time minimal invasive mitral valve surgery.
Who cannot join
- Cardiogenic shock or cardiac arrest, emergent CABG
- Renal failure (with a GFR < 30 ml/min/1.73m2),
- Glibenclamide or nicorandil (as these medications may interfere with VC)
- Pregnancy
- Known intolerance/allergy to sevoflurane or propofol
Trial locations and contacts
1 site in 1 country.
Alessandra Parlanti, Pharmacist contact
Italy1 site, 1 recruiting
- Recruiting
Ospedale del cuore, Pasquinucci Hospital, Fondazione Monasterio
Massa, Italy
Marco Moscarelli, MD, 0044 07587163062, m.moscarelli@imperial.ac.uk
Dorela Haxhiademi, MD, dorela_h@yahoo.com
About this study
Official title: A Single-center Observational Study Investigating the Effect of Volatile Conditioning (VC) With Sevoflurane on Myocardial Biomarkers and Platelets Function in Patients Having Minimally Invasive Mitral Valve Surgery (MIMV)
The main aim of this study is to compare markers of cardiac injury (Troponin I), inflammatory response and platelets function during minimally invasive mitral valve repair or replacement (MIMV) via right mini-thoracotomy in two standard anaesthetic regimes (sevo \propofol)
Read the detailed description
The main aim of this study is to compare markers of cardiac injury (Troponin I), inflammatory response and platelets function during minimally invasive mitral valve repair or replacement (MIMV) via right mini-thoracotomy in two standard anaesthetic regimes:
- Volatile conditioning (sevoflurane) used during induction (preconditioning) and during the operation as maintenance (perconditioning) and no propofol.
- Propofol induction and maintenance (TIVA) and no volatile anaesthetics.
Outlet/residual blood samples coming from routine check will be collected at different time points.
Study will be powered on Troponin I (primary statistical outcome). Original secondary outcome will be considered: platelets activation, left ventricle function, clinical figures (length of stay, inotrops requirements, ventilation times and other relevant).
- Conditions
- Myocardial Ischemia
- Being tested
- sevofluorane
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sevofluoraneDrug
Also called SEVO
Continuous infusion of sevofluorane
| Study group | Role | What they receive |
|---|---|---|
| Sevofluorane | Patients preconditioned with Sevo Receives: Drug: sevofluorane | |
| Propofol | Patients with no preconditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial Injury assessed by changes in Troponin values
According to the routine post operative blood testing frame-time troponin sample will collected in the preoperative and postoperative period.
Measured: properatively-6, 12, 24, 48 and 72 hours after the end of ischaemic cardioplegic arrest
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2015 (estimated)
- Study startJun 2015
- Primary completionMar 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial IschemiaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Toscana Gabriele Monasterio
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MOSCARELLI MARCO, Fondazione Toscana Gabriele Monasterio
- Investigators
- Paolo Del Sarto, MD, Principal investigator, Fondazione Toscana Gabriele Monasterio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02551328
- Sponsor's protocol ID
- 452/2014
- Acronym
- MINI-SEVO
- Status last verified
- Sep 2015
- First submitted
- 1 Sep 2015
- Last updated
- 16 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center Observational Study Investigating the Effect of Volatile Conditioning (VC) With Sevoflurane on Myocardial Biomarkers and Platelets Function in Patients Having Minimally Invasive Mitral Valve Surgery (MIMV)
- ClinicalTrials.gov ID
- NCT02551328
- Acronym / sponsor ID
- MINI-SEVO / 452/2014
- Conditions
- Myocardial Ischemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Fondazione Toscana Gabriele MonasterioUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 16 Sep 2015 (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.
The main aim of this study is to compare markers of cardiac injury (Troponin I), inflammatory response and platelets function during minimally invasive mitral valve repair or replacement (MIMV) via right mini-thoracotomy in two standard anaesthetic regimes (sevo \propofol)
Detailed description
The main aim of this study is to compare markers of cardiac injury (Troponin I), inflammatory response and platelets function during minimally invasive mitral valve repair or replacement (MIMV) via right mini-thoracotomy in two standard anaesthetic regimes:
- Volatile conditioning (sevoflurane) used during induction (preconditioning) and during the operation as maintenance (perconditioning) and no propofol.
- Propofol induction and maintenance (TIVA) and no volatile anaesthetics.
Outlet/residual blood samples coming from routine check will be collected at different time points.
Study will be powered on Troponin I (primary statistical outcome). Original secondary outcome will be considered: platelets activation, left ventricle function, clinical figures (length of stay, inotrops requirements, ventilation times and other relevant).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sevofluorane | – | Drug: sevofluoranePatients preconditioned with Sevo |
| Propofol | – | –Patients with no preconditioning |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Age>=18 Pt undergoing elective (or urgent) first-time minimal invasive mitral valve surgery Pt will have to sign informed consent
Key inclusion criteria (2 listed)
- Age ≥18
- Patients undergoing elective (or urgent) first-time minimal invasive mitral valve surgery.
Key exclusion criteria (5 listed)
- Cardiogenic shock or cardiac arrest, emergent CABG
- Renal failure (with a GFR < 30 ml/min/1.73m2),
- Glibenclamide or nicorandil (as these medications may interfere with VC)
- Pregnancy
- Known intolerance/allergy to sevoflurane or propofol
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 |
|---|---|---|
| sevofluoraneAlso: SEVOContinuous infusion of sevofluorane | Drug | Sevofluorane |
Primary outcome
Myocardial Injury assessed by changes in Troponin values
Time frame: properatively-6, 12, 24, 48 and 72 hours after the end of ischaemic cardioplegic arrest
According to the routine post operative blood testing frame-time troponin sample will collected in the preoperative and postoperative period.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2015.
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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.
Alessandra Parlanti, Pharmacist contact
Paolo Del Sarto, MD principal investigator
Fondazione Toscana Gabriele Monasterio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Ischemia, run by Fondazione Toscana Gabriele Monasterio at 1 site in Italy.
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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 16 Sep 2015. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alessandra Parlanti, Pharmacist (0039/0585/493675/493565, alessandra.parlanti@ftgm.it-parlantialessandra@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myocardial Injury assessed by changes in Troponin values (time frame: properatively-6, 12, 24, 48 and 72 hours after the end of ischaemic cardioplegic arrest). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Sep 2015.