Myocardial InfarctionNCT02932722
Effect of Propofol on Cardioprotective Role of Remote Ischemic Preconditioning (RIPC)
A study testing Propofol and Sevoflurane in people with Myocardial Infarction, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study involves research using human subjects (cardiac surgical patients) to evaluate the effect of remote ischemic preconditioning (RIPC) on cardioprotective outcomes. RIPC applied to upper or lower extremities has been shown cardioprotective role by lowering release of cardiac troponin in patients with cardiac… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Propofol and Sevoflurane
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Feb 2017to 7 Feb 2018
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA class I~III patients undergoing cardiac surgery using cardiopulmonary bypass
Who cannot join
- Cardiac surgery without using cardiopulmonary bypass
- Descending thoracic aortic surgery
- Strenuous exercise, excessive alcohol or caffeine intake 24 hours before remote ischemic preconditioning
- Left ventricular ejection fraction < 30%
- Uncontrolled hypertension or diabetes mellitus
- Severe renal or hepatic dysfunction
Show all 14Show fewer
- Patients on hemodialysis
- Patients with arterio-venous fistula on arms or any reason to protect arms
- Peripheral vascular or nerve disease, bleeding tendency
- Preoperative use of IABP, ECMO, or ventricular assist devices
- Emergency operation, redo operation
- Refuse to enroll
- Pregnancy
- Preoperative use of beta-blockers
Trial locations and contacts
1 site in 1 country.
About this study
This study involves research using human subjects (cardiac surgical patients) to evaluate the effect of remote ischemic preconditioning (RIPC) on cardioprotective outcomes. RIPC applied to upper or lower extremities has been shown cardioprotective role by lowering release of cardiac troponin in patients with cardiac diseases. However, it is not clear whether anesthetics, such as propofol or sevoflurane, may impair the cardioprotective effect of RIPC in cardiac surgical patients. Therefore, the purpose of the study is to compare the effects of anesthetics on cardioprotection of RIPC in patients undergoing cardiac surgery.
Read the detailed description
Patients undergoing cardiac surgery using cardiopulmonary bypass will be randomized to control, propofol, or sevoflurane group. Patients in the control group will receive remote ischemic preconditioning (RIPC) on their upper arms before anesthetic induction. Patients in the propofol or sevoflurane groups will receive RIPC after anesthetic induction using propofol or sevoflurane, respectively. In all patients, arterial blood samples will be obtained before and after each RIPC. From the samples, human dialysate will be obtained and perfused to rat heart through Langendorff apparatus before ischemia-reperfusion injury to the rat heart. Infarct size of the sectioned rat heart will be compared among the three - control, propofol, and sevoflurane - groups.
- Conditions
- Myocardial Infarction
- Being tested
- Control, Propofol, Sevoflurane
- Keywords
- Propofol, Sevoflurane, Preconditioning
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlOther
Also called Not receiving any anesthetic
Patients in the control groups do not receive any anesthetic during remote ischemic preconditioning.
PropofolDrug
Also called Receiving propofol anesthesia
Patients in the propofol group receive propofol anesthesia during remote ischemic preconditioning.
SevofluraneDrug
Also called Receiving sevoflurane anesthesia
Patients in the sevoflurane group receive sevoflurane anesthesia during remote ischemic preconditioning.
| Study group | Role | What they receive |
|---|---|---|
| Control | Sham comparator | Patients in the control group will be receive remote ischemic preconditioning before anesthetic induction (before exposure to any anesthetic). Receives: Other: Control |
| Propofol | Active comparator | Patients in the propofol groups will be receive remote ischemic preconditioning after anesthetic induction using propofol, as a main anesthetic. Receives: Drug: Propofol |
| Sevoflurane | Active comparator | Patients in the sevoflurane groups will be receive remote ischemic preconditioning after anesthetic induction using sevoflurane, as a main anesthetic. Receives: Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infarct size of the rat heart
Measured: 1 day after ischemia-reperfusion injury
Secondary outcomes (2)
Cardiac troponin I after surgery
Measured: 72 hours postoperatively
Major adverse cardiovascular and cerebrovascular events
Measured: Through study completion, average of 2 weeks before hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2016 (estimated)
- Study start22 Feb 2017
- Primary completion7 Feb 2018
- Study completion7 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yunseok Jeon, Seoul National University Hospital
- Investigators
- Yunseok Jeon, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02932722
- Sponsor's protocol ID
- RIPC_propofol
- Other IDs
- 1605-079-761
- Status last verified
- Feb 2018
- First submitted
- 26 Sep 2016
- Last updated
- 20 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- 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 20 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Propofol on Cardioprotective Role of Remote Ischemic Preconditioning (RIPC)
- ClinicalTrials.gov ID
- NCT02932722
- Acronym / sponsor ID
- RIPC_propofol
- Conditions
- Myocardial Infarction
- Keywords
- Propofol, Sevoflurane, Preconditioning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 22 Feb 2017 (actual)
- Primary completion
- 7 Feb 2018 (actual)
- Study completion
- 7 Feb 2018 (actual)
- First posted
- 13 Oct 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 involves research using human subjects (cardiac surgical patients) to evaluate the effect of remote ischemic preconditioning (RIPC) on cardioprotective outcomes. RIPC applied to upper or lower extremities has been shown cardioprotective role by lowering release of cardiac troponin in patients with cardiac diseases. However, it is not clear whether anesthetics, such as propofol or sevoflurane, may impair the cardioprotective effect of RIPC in cardiac surgical patients. Therefore, the purpose of the study is to compare the effects of anesthetics on cardioprotection of RIPC in patients undergoing cardiac surgery.
Detailed description
Patients undergoing cardiac surgery using cardiopulmonary bypass will be randomized to control, propofol, or sevoflurane group. Patients in the control group will receive remote ischemic preconditioning (RIPC) on their upper arms before anesthetic induction. Patients in the propofol or sevoflurane groups will receive RIPC after anesthetic induction using propofol or sevoflurane, respectively. In all patients, arterial blood samples will be obtained before and after each RIPC. From the samples, human dialysate will be obtained and perfused to rat heart through Langendorff apparatus before ischemia-reperfusion injury to the rat heart. Infarct size of the sectioned rat heart will be compared among the three - control, propofol, and sevoflurane - groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Sham comparator | Other: ControlPatients in the control group will be receive remote ischemic preconditioning before anesthetic induction (before exposure to any anesthetic). |
| Propofol | Active comparator | Drug: PropofolPatients in the propofol groups will be receive remote ischemic preconditioning after anesthetic induction using propofol, as a main anesthetic. |
| Sevoflurane | Active comparator | Drug: SevofluranePatients in the sevoflurane groups will be receive remote ischemic preconditioning after anesthetic induction using sevoflurane, as a main anesthetic. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA class I~III patients undergoing cardiac surgery using cardiopulmonary bypass
Key exclusion criteria (14 listed)
- Cardiac surgery without using cardiopulmonary bypass
- Descending thoracic aortic surgery
- Strenuous exercise, excessive alcohol or caffeine intake 24 hours before remote ischemic preconditioning
- Left ventricular ejection fraction < 30%
- Uncontrolled hypertension or diabetes mellitus
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 |
|---|---|---|
| ControlAlso: Not receiving any anestheticPatients in the control groups do not receive any anesthetic during remote ischemic preconditioning. | Other | Control |
| PropofolAlso: Receiving propofol anesthesiaPatients in the propofol group receive propofol anesthesia during remote ischemic preconditioning. | Drug | Propofol |
| SevofluraneAlso: Receiving sevoflurane anesthesiaPatients in the sevoflurane group receive sevoflurane anesthesia during remote ischemic preconditioning. | Drug | Sevoflurane |
Primary outcome
Infarct size of the rat heart
Time frame: 1 day after ischemia-reperfusion injury
2 secondary outcomes
Cardiac troponin I after surgery
Time frame: 72 hours postoperatively
Major adverse cardiovascular and cerebrovascular events
Time frame: Through study completion, average of 2 weeks before hospital discharge
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 20 Feb 2018.
- 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.
Yunseok Jeon, MD, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propofol and Sevoflurane in people with Myocardial Infarction, run by Seoul National University Hospital at 1 site in South Korea.
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 1 inclusion and 14 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 20 Feb 2018. 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 South Korea. 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. Some participants in this study may receive a placebo. 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?
Infarct size of the rat heart (time frame: 1 day after ischemia-reperfusion injury). 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 20 Feb 2018.