Mitral Valve InsufficiencyPhase 1NCT05742789
Effect of Anesthetics on Troponin I and С-reactive Protein
A Phase 1 study testing Propofol, Isoflurane and Sevoflurane in people with Mitral Valve Insufficiency and Aortic Valve Insufficiency, run by Astana Medical University at 1 site in Kazakhstan.
Trial summary
Abstract Troponin is one of the cardiac biomarkers and its high level correlates to high risk of cardiac myocytes damage. C-reactive protein (CRP) in cardiosurgery participates in the Systemic Inflammation Response Syndrome, and heart-lung apparatus is a powerful stimulator of the systemic inflammatory reaction. Read more about this study
- Who is it for?
- Ages 50 to 65 years
- Conditions the study is for
- Mitral Valve Insufficiency, Aortic Valve Insufficiency, Cardiac Disease
- What is being tested?
- Propofol, Isoflurane and Sevoflurane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 255 participants
- Where
- 1 siteKazakhstan
- Study dates
- 30 Nov 2021to 9 Jan 2023
- Phase
- Phase 1
- 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 50 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The age is between 50-65 years old;
- Mitral and aortic valve insufficiency grade 3-4;
- Participants of both sexes will be included in the study;
- Planned surgical interventions;
- Signed informed consent.
Who cannot join
- pregnancy (risk to the baby and mother)
- hypertensive disease
- coronary artery disease;
- current unstable angina pectoris;
- preoperative hemodynamic instability, defined as the use of vasopressors;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Anesthetics on Troponin I and С-reactive Protein in Mitral, Tricuspid and Aortic Valve Replacement/Plastic in Adult: a Randomized Clinical Study
Abstract Troponin is one of the cardiac biomarkers and its high level correlates to high risk of cardiac myocytes damage. C-reactive protein (CRP) in cardiosurgery participates in the Systemic Inflammation Response Syndrome, and heart-lung apparatus is a powerful stimulator of the systemic inflammatory reaction.
Objective: To assess effect of anesthetics on troponin I and СRP in mitral, tricuspid and aortic valve replacement/plastic in adult.
Read more
Methods. Single-center prospective randomized controlled clinical study. A total of 95 patients were assigned randomly into three groups according to the type of anesthesia: the first group of 32 patients with propofol, the second group with sevoflurane - 32 patients, and the last - 31 patients were with isoflurane.
Levels of the cardiac troponin I were calculated in ng/ml с using a portable fluorometric analyzer I-CHROMAII, manufacture of BoditechMedInc (South Korea). Normal range: <0.04 ng/ml. CRP concentration in plasma has been determined using a biochemical analyzer Biosystems BA-200 (Spanish company, Barcelona) according to the manufacturer's instructions. The normal level of CRP is less than 5 mg/l.
Read the detailed description
The examination and treatment data of 95 patients operated in the departments of cardiovascular surgery of the City multidisciplinary hospital No. 2 were included in the study. All patients underwent mitral, aortic, tricuspid valve replacement/plasty under cardiopulmonary bypass (CPB) conditions. This research work was conducted between 2021 and 2023. To calculate the sample size, we used the formula n=t2*D*N/confidence interval*N+t2*α, which will allow to identify the static significance of the study.
Inclusion criteria: insufficiency of mitral, tricuspid and aortic valves of 3-4th degree; only planned surgeries; age range 40-60 years old; patients corresponding to II-III grade according to the scale of the American Society of Anaesthesiologists.
Exclusion criteria: pregnancy; acute coronary syndrome; hemodynamic instability.
All patients were assigned randomly into three groups according to the type of anesthesia: the first group of 32 patients with propofol, the second group with sevoflurane - 32 patients, and the last - 31 patients were with isoflurane.
The level of cardiac troponin I were calculated in ng/ml using a portable fluorometric analyzer i-CHROMAII, production of BoditechMedInc (South Korea). The normal range: <0.04 ng/ml. The analyzer Triage® Meter Pro of Alere San Diego Inc. production (USA).
Three blood samples were taken in the patients before the anaesthesia, in 12 hours post-surgery and in 48 hours post-surgery. Blood samples were taken in the sterile test-tubes, containing no EDTA and heparin, centrifugated and stored at temperature -20 °С to avoid the erroneously low results.
CRP concentrations in plasma were determined using the biochemical analyzer Biosystems BA-200 (Spanish company, Barcelona) according to the manufacturer's instructions. The normal level of CRP is less than 5 mg/l. Blood samples were taken in the patients before the anaesthesia, 1st day post-surgery, 3rd and 5th days post-surgery.
- Being tested
- Propofol, Isoflurane, Sevoflurane
- Keywords
- Mitral Valve Insufficiency, Aortic Valve Insufficiency, Troponin I, propofol, isoflurane, sevoflurane
- Medical subject headings
- Mitral Valve Insufficiency, Aortic Valve Insufficiency, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Also called Propofol;
To maintain anaesthesia in Group 1 P, propofol was used as an anaesthetic in a dose of 4-6 mg/kg/h intravenously on a perfusor
IsofluraneDrug
В качестве анестетика использовали изофлуран - 1,1-1,2 MAC.
SevofluraneDrug
в качестве анестетика использовали севофлуран в дозе - 1,7-1,9 ПДК.
| Study group | Role | What they receive |
|---|---|---|
| Propofol | Other | Anesthesia Receives: Drug: Propofol |
| Isofluran | Other | Anesthesia Receives: Drug: Isoflurane |
| Sevofluran | Other | Anesthesia Receives: Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Troponin I
Cardiac troponin I levels were calculated in ng/mL using the i-CHROMAII portable fluorescent analyzer manufactured by BoditechMedInc. (South Korea). Normal range: <0.4 ng/mL.
Measured: 2 year
С-reactive protein
С-reactive protein concentrations in plasma were determined using the biochemical analyzer Biosystems BA-200 (Spanish company, Barcelona) according to the manufacturer's instructions.
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2023
- Study start30 Nov 2021
- Primary completion4 Jan 2023
- Study completion9 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral Valve InsufficiencyStudies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 255 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astana Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bekzat Baiterek, Astana Medical University
- Investigators
- Alibek Kh Mustafin, Professor, Study director, Astana Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05742789
- Sponsor's protocol ID
- 6
- Status last verified
- Jun 2023
- First submitted
- 15 Feb 2023
- Last updated
- 5 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Anesthetics on Troponin I and С-reactive Protein in Mitral, Tricuspid and Aortic Valve Replacement/Plastic in Adult: a Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT05742789
- Acronym / sponsor ID
- 6
- Keywords
- Mitral Valve Insufficiency, Aortic Valve Insufficiency, Troponin I, propofol, isoflurane, sevoflurane
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 255 participants (actual)
- Lead sponsor
- Astana Medical UniversityUniversity, hospital or other
- Study start
- 30 Nov 2021 (actual)
- Primary completion
- 4 Jan 2023 (actual)
- Study completion
- 9 Jan 2023 (actual)
- First posted
- 24 Feb 2023 (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.
Abstract Troponin is one of the cardiac biomarkers and its high level correlates to high risk of cardiac myocytes damage. C-reactive protein (CRP) in cardiosurgery participates in the Systemic Inflammation Response Syndrome, and heart-lung apparatus is a powerful stimulator of the systemic inflammatory reaction.
Objective: To assess effect of anesthetics on troponin I and СRP in mitral, tricuspid and aortic valve replacement/plastic in adult.
Methods. Single-center prospective randomized controlled clinical study. A total of 95 patients were assigned randomly into three groups according to the type of anesthesia: the first group of 32 patients with propofol, the second group with sevoflurane - 32 patients, and the last - 31 patients were with isoflurane.
Levels of the cardiac troponin I were calculated in ng/ml с using a portable fluorometric analyzer I-CHROMAII, manufacture of BoditechMedInc (South Korea). Normal range: <0.04 ng/ml. CRP concentration in plasma has been determined using a biochemical analyzer Biosystems BA-200 (Spanish company, Barcelona) according to the manufacturer's instructions. The normal level of CRP is less than 5 mg/l.
Detailed description
The examination and treatment data of 95 patients operated in the departments of cardiovascular surgery of the City multidisciplinary hospital No. 2 were included in the study. All patients underwent mitral, aortic, tricuspid valve replacement/plasty under cardiopulmonary bypass (CPB) conditions. This research work was conducted between 2021 and 2023. To calculate the sample size, we used the formula n=t2*D*N/confidence interval*N+t2*α, which will allow to identify the static significance of the study.
Inclusion criteria: insufficiency of mitral, tricuspid and aortic valves of 3-4th degree; only planned surgeries; age range 40-60 years old; patients corresponding to II-III grade according to the scale of the American Society of Anaesthesiologists.
Exclusion criteria: pregnancy; acute coronary syndrome; hemodynamic instability.
All patients were assigned randomly into three groups according to the type of anesthesia: the first group of 32 patients with propofol, the second group with sevoflurane - 32 patients, and the last - 31 patients were with isoflurane.
The level of cardiac troponin I were calculated in ng/ml using a portable fluorometric analyzer i-CHROMAII, production of BoditechMedInc (South Korea). The normal range: <0.04 ng/ml. The analyzer Triage® Meter Pro of Alere San Diego Inc. production (USA).
Three blood samples were taken in the patients before the anaesthesia, in 12 hours post-surgery and in 48 hours post-surgery. Blood samples were taken in the sterile test-tubes, containing no EDTA and heparin, centrifugated and stored at temperature -20 °С to avoid the erroneously low results.
CRP concentrations in plasma were determined using the biochemical analyzer Biosystems BA-200 (Spanish company, Barcelona) according to the manufacturer's instructions. The normal level of CRP is less than 5 mg/l. Blood samples were taken in the patients before the anaesthesia, 1st day post-surgery, 3rd and 5th days post-surgery.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Propofol | Other | Drug: PropofolAnesthesia |
| Isofluran | Other | Drug: IsofluraneAnesthesia |
| Sevofluran | Other | Drug: SevofluraneAnesthesia |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The age is between 50-65 years old;
- Mitral and aortic valve insufficiency grade 3-4;
- Participants of both sexes will be included in the study;
- Planned surgical interventions;
- Signed informed consent.
Key exclusion criteria (5 listed)
- pregnancy (risk to the baby and mother)
- hypertensive disease
- coronary artery disease;
- current unstable angina pectoris;
- preoperative hemodynamic instability, defined as the use of vasopressors;
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 |
|---|---|---|
| PropofolAlso: Propofol;To maintain anaesthesia in Group 1 P, propofol was used as an anaesthetic in a dose of 4-6 mg/kg/h intravenously on a perfusor | Drug | Propofol |
| IsofluraneВ качестве анестетика использовали изофлуран - 1,1-1,2 MAC. | Drug | Isofluran |
| Sevofluraneв качестве анестетика использовали севофлуран в дозе - 1,7-1,9 ПДК. | Drug | Sevofluran |
Primary outcome
Troponin I
Time frame: 2 year
Cardiac troponin I levels were calculated in ng/mL using the i-CHROMAII portable fluorescent analyzer manufactured by BoditechMedInc. (South Korea). Normal range: <0.4 ng/mL.
С-reactive protein
Time frame: 2 year
С-reactive protein concentrations in plasma were determined using the biochemical analyzer Biosystems BA-200 (Spanish company, Barcelona) according to the manufacturer's instructions.
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 Jun 2023.
- Individual participant dataSharing planned: No
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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.
Alibek Kh Mustafin, Professor study director
Astana Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Propofol, Isoflurane and Sevoflurane in people with Mitral Valve Insufficiency and Aortic Valve Insufficiency, run by Astana Medical University at 1 site in Kazakhstan.
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 5 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: finished, as of the sponsor's last update on 5 Jun 2023. 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 Kazakhstan. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Troponin I (time frame: 2 year). The study lists 2 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 5 Jun 2023.