MicrocirculationNCT03089814
Changes in Tissue Microcirculation During Ischemic Conditioning: Pilot Study
A study testing ischemic conditioning in people with Microcirculation, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Changes in tissue microcirculation during ischemic conditioning (4 cycles of 5-min ischemia and 5-min reperfusion) has not been well documented. In previous studies, there was difference in changes in microcirculation, such as recovery slope and occlusion slope, between healthy subjects and cardiac surgery patients. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Microcirculation
- What is being tested?
- ischemic conditioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 Mar 2017to 10 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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 20-45
- No underlying chronic disease
- Male volunteer
- Age 20-80
- Scheduled for cardiac surgery
Who cannot join
- Under taking prescription drugs
- Taking herbal medicines within 2 weeks
- Baseline systolic blood pressure > 150 mmHg or diastolic pressure > 100 mmHg
- Body mass index < 18 kg/m^2 or > 30 kg/m^2
- Vigorous exercise, excessive alcohol, smoking or caffeine within 24 hours
- Any abnormalities on upper extremities
Show all 19Show fewer
- Do not consent to participate
- <Cardiac surgery patients>
- Baseline systolic blood pressure > 150 mmHg or diastolic pressure > 100 mmHg
- Body mass index < 18 kg/m^2 or > 30 kg/m^2
- Uncontrolled diabetes
- Under taking beta-blockers
- Severe renal dysfunction, chronic kidney disease, on hemodialysis
- Any abnormalities on upper extremities (i.e, AV fistula on arms)
- Peripheral vascular disease, peripheral neuropathy, coagulopathy
- Vigorous exercise, excessive alcohol, smoking or caffeine within 24 hours
- Pregnant
- Emergency surgery
- Do not consent to participate
Trial locations and contacts
1 site in 1 country.
About this study
Changes in tissue microcirculation during ischemic conditioning (4 cycles of 5-min ischemia and 5-min reperfusion) has not been well documented. In previous studies, there was difference in changes in microcirculation, such as recovery slope and occlusion slope, between healthy subjects and cardiac surgery patients. Moreover, the occlusion slope, which reflects local tissue oxygen consumption during ischemic period, is anticipated to decrease during repeated ischemia-reperfusion cycle by its protecting effect, however there has not been well-conducted study. The purpose of the study is to evaluate the changes in microcirculation measured by tissue oxygen saturation during ischemic conditioning between healthy volunteers and cardiac surgery patients.
Read the detailed description
Subjects who are male healthy volunteers (aged 20-45) or who are scheduled to receive cardiac surgery (aged 20-80) will undergo ischemic conditioning, consisting of 4 cycles of 5-min ischemia with pressure of 200 mmHg on upper extremity followed by 5-min reperfusion with no pressure. During ischemic conditioning, changes in tissue microcirculation (baseline tissue saturation, occlusion slope during ischemia, and recovery slope during reperfusion) will be observed using tissue oxygen saturation sensor attached to the thenar muscle of the hand. For cardiac surgery patients, the study will be conducted before anesthesia induction on the surgery day to exclude any potential effect of anesthetics.
- Conditions
- Microcirculation
- Being tested
- ischemic conditioning
- Keywords
- tissue oxygen saturation, ischemic conditioning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ischemic conditioningProcedure or surgery
Four cycles of 5-min inflation of pneumatic cuff on upper extremity up to 200 mmHg, followed by 5-min deflation with no pressure.
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Active comparator | Healthy male volunteers will receive ischemic conditioning (4 cycles of 5-min ischemia followed by 5-min reperfusion on upper extremity) while measuring changes in tissue microcirculation at the thenar muscle. Receives: Procedure: ischemic conditioning |
| Cardiac surgery patients | Active comparator | Patients scheduled for cardiac surgery will receive ischemic conditioning (4 cycles of 5-min ischemia followed by 5-min reperfusion on upper extremity) while measuring changes in tissue microcirculation at the thenar muscle. Receives: Procedure: ischemic conditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in microcirculation during ischemic conditioning
Changes in occlusion slope during ischemia and recovery slope during reperfusion
Measured: During 4-cycles of 5-min ischemia followed by 5-min reperfusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2017
- Study start23 Mar 2017
- Primary completion10 Jul 2017
- Study completion10 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MicrocirculationStudies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 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
- NCT03089814
- Sponsor's protocol ID
- RIPC-VOT
- Status last verified
- Feb 2018
- First submitted
- 14 Mar 2017
- Last updated
- 28 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 28 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Tissue Microcirculation During Ischemic Conditioning: Pilot Study
- ClinicalTrials.gov ID
- NCT03089814
- Acronym / sponsor ID
- RIPC-VOT
- Conditions
- Microcirculation
- Keywords
- tissue oxygen saturation, ischemic conditioning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 23 Mar 2017 (actual)
- Primary completion
- 10 Jul 2017 (actual)
- Study completion
- 10 Jul 2017 (actual)
- First posted
- 24 Mar 2017 (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.
Changes in tissue microcirculation during ischemic conditioning (4 cycles of 5-min ischemia and 5-min reperfusion) has not been well documented. In previous studies, there was difference in changes in microcirculation, such as recovery slope and occlusion slope, between healthy subjects and cardiac surgery patients. Moreover, the occlusion slope, which reflects local tissue oxygen consumption during ischemic period, is anticipated to decrease during repeated ischemia-reperfusion cycle by its protecting effect, however there has not been well-conducted study. The purpose of the study is to evaluate the changes in microcirculation measured by tissue oxygen saturation during ischemic conditioning between healthy volunteers and cardiac surgery patients.
Detailed description
Subjects who are male healthy volunteers (aged 20-45) or who are scheduled to receive cardiac surgery (aged 20-80) will undergo ischemic conditioning, consisting of 4 cycles of 5-min ischemia with pressure of 200 mmHg on upper extremity followed by 5-min reperfusion with no pressure. During ischemic conditioning, changes in tissue microcirculation (baseline tissue saturation, occlusion slope during ischemia, and recovery slope during reperfusion) will be observed using tissue oxygen saturation sensor attached to the thenar muscle of the hand. For cardiac surgery patients, the study will be conducted before anesthesia induction on the surgery day to exclude any potential effect of anesthetics.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | Active comparator | Procedure: ischemic conditioningHealthy male volunteers will receive ischemic conditioning (4 cycles of 5-min ischemia followed by 5-min reperfusion on upper extremity) while measuring changes in tissue microcirculation at the thenar muscle. |
| Cardiac surgery patients | Active comparator | Procedure: ischemic conditioningPatients scheduled for cardiac surgery will receive ischemic conditioning (4 cycles of 5-min ischemia followed by 5-min reperfusion on upper extremity) while measuring changes in tissue microcirculation at the thenar muscle. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 20-45
- No underlying chronic disease
- Male volunteer
- Age 20-80
- Scheduled for cardiac surgery
Key exclusion criteria (19 listed)
- Under taking prescription drugs
- Taking herbal medicines within 2 weeks
- Baseline systolic blood pressure > 150 mmHg or diastolic pressure > 100 mmHg
- Body mass index < 18 kg/m^2 or > 30 kg/m^2
- Vigorous exercise, excessive alcohol, smoking or caffeine within 24 hours
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 |
|---|---|---|
| ischemic conditioningFour cycles of 5-min inflation of pneumatic cuff on upper extremity up to 200 mmHg, followed by 5-min deflation with no pressure. | Procedure or surgery | Cardiac surgery patients, Healthy volunteers |
Primary outcome
Changes in microcirculation during ischemic conditioning
Time frame: During 4-cycles of 5-min ischemia followed by 5-min reperfusion
Changes in occlusion slope during ischemia and recovery slope during 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 28 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 ischemic conditioning in people with Microcirculation, 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 5 inclusion and 19 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 28 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. 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?
Changes in microcirculation during ischemic conditioning (time frame: During 4-cycles of 5-min ischemia followed by 5-min reperfusion). 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 28 Feb 2018.