Ischemic PreconditioningRIPCANCT02965547
Remote Ischemic Preconditioning of Dynamic Cerebral Autoregulation in Healthy Adults
A study testing Remote ischemic conditioning equipment, Intravenous blood collection and dCA measurement in people with Ischemic Preconditioning, run by Yi Yang at 1 site in China.
Trial summary
The purpose of this study is to determine the impact of remote ischemic preconditioning on dynamic cerebral autoregulation and related hematology indexes in healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Ischemic Preconditioning
- What is being tested?
- Remote ischemic conditioning equipment, Intravenous blood collection and dCA measurement
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2017to 25 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age from 18 to 70,both genders
- Willing to participate in follow-up visits
Who cannot join
- current or having a history of chronic physical diseases or mental diseases
- suffering from infectious diseases in late one month
- pregnant and lactating women；
- smoking or drinking；
- inability to cooperate sufficiently to complete the dCA examination
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine the impact of remote ischemic preconditioning on dynamic cerebral autoregulation and related hematology indexes in healthy adults.
Read the detailed description
Remote ischemic preconditioning(RIPC) is the phenomenon whereby brief cycles of ischemia and reperfusion, applied to a distant organ, provide protection to the target organ. Dynamic cerebral autoregulation(dCA), a mechanism to maintain the cerebral blood flow, has been proved to be critical for the occurrence,development and prognosis of ischemic neurovascular disease. In this study, we hypothesis that RIPC provides neuro-protection by means of improving dCA.
- Conditions
- Ischemic Preconditioning
- Being tested
- Remote ischemic conditioning equipment, Intravenous blood collection, dCA measurement
- Keywords
- Ischemic Preconditioning, dynamic cerebral autoregulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote ischemic conditioning equipmentDevice
The RIPC consisted of 4 cycles of extremities ischemia (5-minute blood-pressure cuff inflation to 200 mm Hg, followed by 5-minute cuff deflation). The tourniquets were applied to one side upper arm and other side thigh. This intervention was undertaken one time in total.
Intravenous blood collectionProcedure or surgery
Nurses will collect intravenous blood 6ml twice(at baseline and 1h after RIPC).The blood samples will be stored for laboratory test.The blood samples only use for the trial.
dCA measurementProcedure or surgery
Serial measurements of dCA were performed at 7 time points, baseline, 1h, 3h, 6h, 9h, 12h, 24h after RIPC.The continuous ABP was measured non-invasively using a servo-controlled plethysmograph (Finometer Pro, the Netherlands) at the middle finger. Two 2 MHz transcranial Doppler probe was used to measure continuous cerebral blood flow velocity (CBFV) simultaneously in the bilateral middle cerebral arteries at a depth of 45-60 mm Endtidal CO2 was monitored using a capnograph (MultiDop X2, DWL, Sipplingen, Germany). The probes were placed over temporal windows and fixed with a customized head frame. CBFV and continuous arterial blood pressure were recorded simultaneously from each subject in the supine position for 10 minutes. All data were recorded for further assessment and analysis.
| Study group | Role | What they receive |
|---|---|---|
| RIPC Group | Experimental | RIPC was induced by 4 cycles of extremities ischemia (5-minute blood-pressure cuff inflation to 200 mm Hg, followed by 5-minute cuff deflation).All subjects will take RIPC intervention, blood collection and 7 dCA measurements. Receives: Device: Remote ischemic conditioning equipment; Procedure: Intravenous blood collection; Procedure: dCA measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
phase difference(PD) in degree
A dynamic cerebral auto-regulation parameter derived from transfer function analysis.Continuous cerebral blood flow velocities of bilateral middle cerebral artery will be assessed noninvasively using transcranial Doppler. Spontaneous arterial blood pressure will be simultaneously recorded using a servo-controlled plethysmograph on the left or right middle finger with an appropriate finger cuff size. Transfer function analysis will be used to derive the autoregulatory parameters.
Measured: 2 days
the rate of recovery of cerebral blood flow velocity
Measured: 2 days
gain in cm/s/mmHg
Measured: 2 days
Secondary outcomes (3)
resistance index (RI) changes from supine to upright position
Measured: 2 days
pulsatility index (PI) changes from supine to upright position
Measured: 2 days
mean middle cerebral artery blood flow velocity (mCBFV) changes from supine to upright position
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2016 (estimated)
- Study start1 Jan 2017
- Primary completionMay 2017
- Study completion25 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ischemic PreconditioningStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yi Yang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yi Yang, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02965547
- Sponsor's protocol ID
- RIPCA
- Acronym
- RIPCA
- Status last verified
- Dec 2016
- First submitted
- 14 Nov 2016
- Last updated
- 24 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Qu Y, Liu J, Guo ZN, Zhang PD, Yan XL, Zhang P, Qi S, Yang Y. The Impact of Remote Ischaemic Conditioning on Beat-to-Beat Heart Rate Variability Circadian Rhythm in Healthy Adults. Heart Lung Circ. 2021 Apr;30(4):531-539. doi: 10.1016/j.hlc.2020.08.017. Epub 2020 Oct 5.
PubMed 33032892Guo ZN, Guo WT, Liu J, Chang J, Ma H, Zhang P, Zhang FL, Han K, Hu HH, Jin H, Sun X, Simpson DM, Yang Y. Changes in cerebral autoregulation and blood biomarkers after remote ischemic preconditioning. Neurology. 2019 Jul 2;93(1):e8-e19. doi: 10.1212/WNL.0000000000007732. Epub 2019 May 29.
PubMed 31142636
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Ischemic Preconditioning of Dynamic Cerebral Autoregulation in Healthy Adults
- ClinicalTrials.gov ID
- NCT02965547
- Acronym / sponsor ID
- RIPCA / RIPCA
- Conditions
- Ischemic Preconditioning
- Keywords
- Ischemic Preconditioning, dynamic cerebral autoregulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Yi YangUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- 25 Jul 2017 (actual)
- First posted
- 16 Nov 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.
The purpose of this study is to determine the impact of remote ischemic preconditioning on dynamic cerebral autoregulation and related hematology indexes in healthy adults.
Detailed description
Remote ischemic preconditioning(RIPC) is the phenomenon whereby brief cycles of ischemia and reperfusion, applied to a distant organ, provide protection to the target organ. Dynamic cerebral autoregulation(dCA), a mechanism to maintain the cerebral blood flow, has been proved to be critical for the occurrence,development and prognosis of ischemic neurovascular disease. In this study, we hypothesis that RIPC provides neuro-protection by means of improving dCA.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RIPC Group | Experimental | Device: Remote ischemic conditioning equipment, Procedure: Intravenous blood collection, Procedure: dCA measurementRIPC was induced by 4 cycles of extremities ischemia (5-minute blood-pressure cuff inflation to 200 mm Hg, followed by 5-minute cuff deflation).All subjects will take RIPC intervention, blood collection and 7 dCA measurements. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age from 18 to 70,both genders
- Willing to participate in follow-up visits
Key exclusion criteria (5 listed)
- current or having a history of chronic physical diseases or mental diseases
- suffering from infectious diseases in late one month
- pregnant and lactating women；
- smoking or drinking；
- inability to cooperate sufficiently to complete the dCA examination
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 |
|---|---|---|
| Remote ischemic conditioning equipmentThe RIPC consisted of 4 cycles of extremities ischemia (5-minute blood-pressure cuff inflation to 200 mm Hg, followed by 5-minute cuff deflation). The tourniquets were applied to one side upper arm and other side thigh. This intervention was undertaken one time in total. | Device | RIPC Group |
| Intravenous blood collectionNurses will collect intravenous blood 6ml twice(at baseline and 1h after RIPC).The blood samples will be stored for laboratory test.The blood samples only use for the trial. | Procedure or surgery | RIPC Group |
| dCA measurementSerial measurements of dCA were performed at 7 time points, baseline, 1h, 3h, 6h, 9h, 12h, 24h after RIPC.The continuous ABP was measured non-invasively using a servo-controlled plethysmograph (Finometer Pro, the Netherlands) at the middle finger. Two 2 MHz transcranial Doppler probe was used to measure continuous cerebral blood flow velocity (CBFV) simultaneously in the bilateral middle cerebral arteries at a depth of 45-60 mm Endtidal CO2 was monitored using a capnograph (MultiDop X2, DWL, Sipplingen, Germany). The probes were placed over temporal windows and fixed with a customized head frame. CBFV and continuous arterial blood pressure were recorded simultaneously from each subject in the supine position for 10 minutes. All data were recorded for further assessment and analysis. | Procedure or surgery | RIPC Group |
Primary outcome
phase difference(PD) in degree
Time frame: 2 days
A dynamic cerebral auto-regulation parameter derived from transfer function analysis.Continuous cerebral blood flow velocities of bilateral middle cerebral artery will be assessed noninvasively using transcranial Doppler. Spontaneous arterial blood pressure will be simultaneously recorded using a servo-controlled plethysmograph on the left or right middle finger with an appropriate finger cuff size. Transfer function analysis will be used to derive the autoregulatory parameters.
the rate of recovery of cerebral blood flow velocity
Time frame: 2 days
gain in cm/s/mmHg
Time frame: 2 days
3 secondary outcomes
resistance index (RI) changes from supine to upright position
Time frame: 2 days
pulsatility index (PI) changes from supine to upright position
Time frame: 2 days
mean middle cerebral artery blood flow velocity (mCBFV) changes from supine to upright position
Time frame: 2 days
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 24 Aug 2021.
- Derived from this study: PubMed 33032892Qu Y, Liu J, Guo ZN, Zhang PD, Yan XL, Zhang P, Qi S, Yang Y. The Impact of Remote Ischaemic Conditioning on Beat-to-Beat Heart Rate Variability Circadian Rhythm in Healthy Adults. Heart Lung Circ. 2021 Apr;30(4):531-539. doi: 10.1016/j.hlc.2020.08.017. Epub 2020 Oct 5.
- Derived from this study: PubMed 31142636Guo ZN, Guo WT, Liu J, Chang J, Ma H, Zhang P, Zhang FL, Han K, Hu HH, Jin H, Sun X, Simpson DM, Yang Y. Changes in cerebral autoregulation and blood biomarkers after remote ischemic preconditioning. Neurology. 2019 Jul 2;93(1):e8-e19. doi: 10.1212/WNL.0000000000007732. Epub 2019 May 29.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote ischemic conditioning equipment, Intravenous blood collection and dCA measurement in people with Ischemic Preconditioning, run by Yi Yang at 1 site in China.
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: finished, as of the sponsor's last update on 24 Aug 2021. 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 China. 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?
phase difference(PD) in degree (time frame: 2 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02965547, which also lists 2 linked publications.
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 24 Aug 2021.