Remote Ischemic ConditioningNCT04899362
The Impact of Serial Remote Ischemic Conditioning on Dynamic Cerebral Autoregulation in Healthy Adults
A study testing BB-RIC-D1/LAPUL Medical Devices Co, Ltd, China, Intravenous blood collection and dCA measurement in people with Remote Ischemic Conditioning, run by The First Hospital of Jilin University at 1 site in China.
Trial summary
The purpose of this study is to determine the impact of serial remote ischemic conditioning on dynamic cerebral autoregulation and related hematology indexes in healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Remote Ischemic Conditioning
- What is being tested?
- BB-RIC-D1/LAPUL Medical Devices Co, Ltd, China, 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
- 36 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2021to 30 Jul 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age from 18 to 50,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 serial remote ischemic conditioning on dynamic cerebral autoregulation and related hematology indexes in healthy adults.
Read the detailed description
Remote ischemic conditioning(RIC) 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 RIC provides neuro-protection by means of improving dCA.
- Conditions
- Remote Ischemic Conditioning
- Being tested
- BB-RIC-D1/LAPUL Medical Devices Co, Ltd, China, Intravenous blood collection, dCA measurement
- Keywords
- Remote Ischemic Conditioning, Dynamic Cerebral Autoregulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BB-RIC-D1/LAPUL Medical Devices Co, Ltd, ChinaDevice
The RIC 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. This intervention was undertaken twice a day for 7 days.
Intravenous blood collectionProcedure or surgery
Nurses will collect intravenous blood 3ml four times (at baseline and the first, seventh and eighth day of the study).The blood samples will be stored for laboratory test.The blood samples only use for the trial.
dCA measurementDevice
Serial measurements of dCA were performed at 10 days, baseline, 1st, 2ed, 4th, 7th, 8th, 10th, 14th, 21th and 35th of the study.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 |
|---|---|---|
| RIC group | Experimental | RIC 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 14 RIC intervention, blood collection and 10 dCA measurements. Receives: Device: BB-RIC-D1/LAPUL Medical Devices Co, Ltd, China; Procedure: Intravenous blood collection; Device: dCA measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic Cerebral Autoregulation Parameter: Phase Difference(PD) in Degree
Dynamic cerebral autoregulation (dCA) is an important indicator of cerebrovascular function which related to the prognosis of cerebrovascular disease. DCA is usually calculated by transfer function analysis. Phase Difference (PD) is gengreated. Low PD at a low frequency band indicates impairment of autoregulation, as it suggests that cerebral blood flow velocity follows the changes in arterial blood pressure with a short delay.
Measured: 36 days
Secondary outcomes (1)
Dynamic Cerebral Autoregulation Parameter: Gain in cm/s/mmHg
High gain at the same frequency band is also considered an indicator of compromised autoregulation for passively transferring the amplitude of arterial blood pressure to cerebral blood flow velocity.
Measured: 36 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study start20 May 2021
- Primary completion19 Jul 2021
- Study completion30 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Remote Ischemic ConditioningStudies of the same condition, open and under way.
- More trials run by The First Hospital of Jilin UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04899362
- Sponsor's protocol ID
- SRIC-CA
- Status last verified
- May 2021
- First submitted
- 10 May 2021
- Last updated
- 3 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Serial Remote Ischemic Conditioning on Dynamic Cerebral Autoregulation in Healthy Adults
- ClinicalTrials.gov ID
- NCT04899362
- Acronym / sponsor ID
- SRIC-CA
- Conditions
- Remote Ischemic Conditioning
- Keywords
- Remote Ischemic Conditioning, Dynamic Cerebral Autoregulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 20 May 2021 (actual)
- Primary completion
- 19 Jul 2021 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 24 May 2021 (actual)
- Results
- Posted 7 Dec 2023
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 serial remote ischemic conditioning on dynamic cerebral autoregulation and related hematology indexes in healthy adults.
Detailed description
Remote ischemic conditioning(RIC) 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 RIC provides neuro-protection by means of improving dCA.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RIC group | Experimental | Device: BB-RIC-D1/LAPUL Medical Devices Co, Ltd, China, Procedure: Intravenous blood collection, Device: dCA measurementRIC 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 14 RIC intervention, blood collection and 10 dCA measurements. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- age from 18 to 50,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 |
|---|---|---|
| BB-RIC-D1/LAPUL Medical Devices Co, Ltd, ChinaThe RIC 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. This intervention was undertaken twice a day for 7 days. | Device | RIC group |
| Intravenous blood collectionNurses will collect intravenous blood 3ml four times (at baseline and the first, seventh and eighth day of the study).The blood samples will be stored for laboratory test.The blood samples only use for the trial. | Procedure or surgery | RIC group |
| dCA measurementSerial measurements of dCA were performed at 10 days, baseline, 1st, 2ed, 4th, 7th, 8th, 10th, 14th, 21th and 35th of the study.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. | Device | RIC group |
Primary outcome
Dynamic Cerebral Autoregulation Parameter: Phase Difference(PD) in Degree
Time frame: 36 days
Dynamic cerebral autoregulation (dCA) is an important indicator of cerebrovascular function which related to the prognosis of cerebrovascular disease. DCA is usually calculated by transfer function analysis. Phase Difference (PD) is gengreated. Low PD at a low frequency band indicates impairment of autoregulation, as it suggests that cerebral blood flow velocity follows the changes in arterial blood pressure with a short delay.
1 secondary outcome
Dynamic Cerebral Autoregulation Parameter: Gain in cm/s/mmHg
Time frame: 36 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 BB-RIC-D1/LAPUL Medical Devices Co, Ltd, China, Intravenous blood collection and dCA measurement in people with Remote Ischemic Conditioning, run by The First Hospital of Jilin University 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 3 Jan 2024. 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?
Yes. Results are posted in the registry (first posted 7 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Dynamic Cerebral Autoregulation Parameter: Phase Difference(PD) in Degree (time frame: 36 days). 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 3 Jan 2024.