Myocardial ProtectionNCT04231903
Myocardial Protection in Minimally Invasive Mitral Valve Surgery
An observational study of Myocardial Protection and Minimally Invasive Surgery, run by University of Turin, Italy.
Trial summary
Perfusion strategies and aortic clamping techniques for right mini-thoracotomy mitral valve (MV) surgery have evolved over time and remarkable short- and long-term results have been re-ported. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Myocardial Protection, Minimally Invasive Surgery, Mitral Valve Prolapse
- What is being tested?
- Aortic clamp
- Type of treatment
- Medical device
- How many people
- 116 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2014to 31 Dec 2018
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All comers at our Deparment with diagnosis of mitral valve disease with surgical indication for mitral valve repair through the right mini-thoracotomy approach and retrograde arterial perfusion.
Who may be able to join
- Surgical indication for mitral valve repair.
- Right mini-thoracotomy approach.
- Retrograde arterial perfusion.
Who cannot join
- Age more than 75 years.
- Cardiac ejection fraction lower than 40%.
- Previous cardiac surgery procedures for coronary artery bypass graft.
- Any degree of coronary artery disease.
- Severe peripheral vascular disease.
- Concomitant procedures for atrial fibrillation ablation.
About this study
Official title: Endo-aortic Versus Trans-thoracic Clamping in Right Mini-thoracotomy Mitral Valve Repair: Outcome on Myocardial Pro-tection
Perfusion strategies and aortic clamping techniques for right mini-thoracotomy mitral valve (MV) surgery have evolved over time and remarkable short- and long-term results have been re-ported. However, some concerns have emerged about the adequacy of myocardial protection dur-ing the minimally invasive approach and about the role of aortic clamping strategies in this contest.
Aim of this study was to compare the efficacy, in terms of myocardial protection, of the en-do-aortic clamp (EAC) versus the trans-thoracic aortic clamp (TTC) in patients undergoing right mini-thoracotomy MV repair.
A single center, prospective observational study was performed between June 2014 to June 2018 on patients undergoing right mini-thoracotomy MV repair with retrograde arterial perfusion and EAC or TTC. The selection of one setting in respect to the other was patient orientated. Myocardial protection was assessed through creatinine kinase-myocardial band (CK-MB) and cardiac Troponin T (cTn-T) blood levels immediately after the surgical procedure and at 6, 12, and 24 hours and compared between the two groups.
- Being tested
- Aortic clamp
- Medical subject headings
- Mitral Valve Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aortic clampDevice
In the firs group an endo-aortic clamp is used and in the second group an external clamp is used.
| Study group | Role | What they receive |
|---|---|---|
| EAC | Patients undergoing surgery endo-aortic clamp. Receives: Device: Aortic clamp | |
| TTC | Patients undergoing surgery through trans-thoracic aortic clamp. Receives: Device: Aortic clamp |
What is being measured
The primary outcome is the main question the study is designed to answer.
cTn-T levels immediately after surgery
Myocardial protection was assessed through cardiac Troponin T (cTn-T) blood levels and compared between the 2 groups of aortic clamping
Measured: Immediately after surgery
CK-MB levels immediately after surgery
Myocardial protection was assessed through creatinine kinase-myocardial band (CK-MB) blood levels after right mini-thoracotomy mitral valve surgery and compared between the 2 groups of aortic clamping
Measured: Immediately after the surgery
cTn-T levels 6h
Myocardial protection was assessed through cardiac Troponin T (cTn-T) blood levels and compared between the 2 groups of aortic clamping
Measured: hour 6 after surgery
CK-MB levels 6h
Myocardial protection was assessed through creatinine kinase-myocardial band (CK-MB) blood levels after right mini-thoracotomy mitral valve surgery and compared between the 2 groups of aortic clamping
Measured: hour 6 after surgery
cTn-T levels 12h
Myocardial protection was assessed through cardiac Troponin T (cTn-T) blood levels and compared between the 2 groups of aortic clamping
Measured: hour 12 after surgery
CK-MB levels 12h
(CK-MB) blood levels after right mini-thoracotomy mitral valve surgery and compared between the 2 groups of aortic clamping
Measured: hour 12 after surgery
cTn-T levels 24h
Myocardial protection was assessed through cardiac Troponin T (cTn-T) blood levels and compared between the 2 groups of aortic clamping
Measured: hour 24 after surgery
CK-MB levels 24h
Myocardial protection was assessed through cardiac Troponin T (cTn-T) blood levels and compared between the 2 groups of aortic clamping
Measured: hour 24 after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start1 Jun 2014
- Primary completion30 Jun 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial ProtectionStudies 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
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cristina Barbero, University of Turin, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04231903
- Sponsor's protocol ID
- 0063123
- Status last verified
- Jan 2020
- First submitted
- 5 Jan 2020
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endo-aortic Versus Trans-thoracic Clamping in Right Mini-thoracotomy Mitral Valve Repair: Outcome on Myocardial Pro-tection
- ClinicalTrials.gov ID
- NCT04231903
- Acronym / sponsor ID
- 0063123
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- 1 Jun 2014 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 18 Jan 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.
Perfusion strategies and aortic clamping techniques for right mini-thoracotomy mitral valve (MV) surgery have evolved over time and remarkable short- and long-term results have been re-ported. However, some concerns have emerged about the adequacy of myocardial protection dur-ing the minimally invasive approach and about the role of aortic clamping strategies in this contest.
Aim of this study was to compare the efficacy, in terms of myocardial protection, of the en-do-aortic clamp (EAC) versus the trans-thoracic aortic clamp (TTC) in patients undergoing right mini-thoracotomy MV repair.
A single center, prospective observational study was performed between June 2014 to June 2018 on patients undergoing right mini-thoracotomy MV repair with retrograde arterial perfusion and EAC or TTC. The selection of one setting in respect to the other was patient orientated. Myocardial protection was assessed through creatinine kinase-myocardial band (CK-MB) and cardiac Troponin T (cTn-T) blood levels immediately after the surgical procedure and at 6, 12, and 24 hours and compared between the two groups.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EAC | – | Device: Aortic clampPatients undergoing surgery endo-aortic clamp. |
| TTC | – | Device: Aortic clampPatients undergoing surgery through trans-thoracic aortic clamp. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All comers at our Deparment with diagnosis of mitral valve disease with surgical indication for mitral valve repair through the right mini-thoracotomy approach and retrograde arterial perfusion.
Key inclusion criteria (3 listed)
- Surgical indication for mitral valve repair.
- Right mini-thoracotomy approach.
- Retrograde arterial perfusion.
Key exclusion criteria (6 listed)
- Age more than 75 years.
- Cardiac ejection fraction lower than 40%.
- Previous cardiac surgery procedures for coronary artery bypass graft.
- Any degree of coronary artery disease.
- Severe peripheral vascular disease.
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 |
|---|---|---|
| Aortic clampIn the firs group an endo-aortic clamp is used and in the second group an external clamp is used. | Device | EAC, TTC |
Primary outcome
cTn-T levels immediately after surgery
Time frame: Immediately after surgery
Myocardial protection was assessed through cardiac Troponin T (cTn-T) blood levels and compared between the 2 groups of aortic clamping
CK-MB levels immediately after surgery
Time frame: Immediately after the surgery
Myocardial protection was assessed through creatinine kinase-myocardial band (CK-MB) blood levels after right mini-thoracotomy mitral valve surgery and compared between the 2 groups of aortic clamping
cTn-T levels 6h
Time frame: hour 6 after surgery
Myocardial protection was assessed through cardiac Troponin T (cTn-T) blood levels and compared between the 2 groups of aortic clamping
CK-MB levels 6h
Time frame: hour 6 after surgery
Myocardial protection was assessed through creatinine kinase-myocardial band (CK-MB) blood levels after right mini-thoracotomy mitral valve surgery and compared between the 2 groups of aortic clamping
cTn-T levels 12h
Time frame: hour 12 after surgery
Myocardial protection was assessed through cardiac Troponin T (cTn-T) blood levels and compared between the 2 groups of aortic clamping
CK-MB levels 12h
Time frame: hour 12 after surgery
(CK-MB) blood levels after right mini-thoracotomy mitral valve surgery and compared between the 2 groups of aortic clamping
cTn-T levels 24h
Time frame: hour 24 after surgery
Myocardial protection was assessed through cardiac Troponin T (cTn-T) blood levels and compared between the 2 groups of aortic clamping
CK-MB levels 24h
Time frame: hour 24 after surgery
Myocardial protection was assessed through cardiac Troponin T (cTn-T) blood levels and compared between the 2 groups of aortic clamping
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 18 Jan 2020.
- Individual participant dataSharing planned: Undecided
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Myocardial Protection
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Protection and Minimally Invasive Surgery, run by University of Turin, 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 3 inclusion and 6 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 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
cTn-T levels immediately after surgery (time frame: Immediately after surgery). The study lists 8 primary outcomes in all. 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 18 Jan 2020.