Pressure; Brachial PlexusPhase 3NCT02414997
The Effect of Remote Ischemic Preconditioning (RIPC) on Blood Pressure and Its Vascular Protection Effect
A Phase 3 study testing RIPC in people with Pressure; Brachial Plexus, run by First Affiliated Hospital, Sun Yat-Sen University.
Trial summary
The purpose of this study is to determine the effect of remote ischemic preconditioning (RIPC) on blood pressure and its vascular protection effect among Chinese young healthy adults and primary hypertensive patients stage I. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Pressure; Brachial Plexus
- What is being tested?
- RIPC
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Dec 2016
- Phase
- Phase 3
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects range from 18 to 80 years old.
- Blood pressure is normal or primary hypertension stage I(systolic blood pressure 140 to 159 mmHg and/or diastolic blood pressure 90 to 99 mmHg).
- No history of smoking( smoking can eliminate the effect of RIPC) or quit smoking for at least 1 years.
- No intake of caffeine or caffeine-containing substances during the process of this trial(caffeine can eliminate the effect of RIPC).
- Provide informed consent and willingness to cooperate with the study protocol.
Who cannot join
- Less than 18 years old or above 80 years old.
- Secondary hypertension.
- Pregnant or lactating females.
- Systemic diseases such as diabetes, HIV/AIDS, liver disease, chronic renal failure, tuberculosis, and autoimmune diseases.
- Medical history of cardiovascular disease: acute myocardial infarct, stable angina, unstable angina, heart failure, atrial fibrillation, atrioventricular blockade, peripheral vascular disease or cerebrovascular accident.
- Patients who are unfavorable of long-term follow-up or poor compliance.
- Patients who are considered unfavorable to take part in this trial by investigators.
About this study
Official title: The Effect of Remote Ischemic Preconditioning (RIPC) on Blood Pressure and Its Vascular Protection Effect Among Chinese Young Healthy Adults and Primary Hypertensive Patients Stage I
The purpose of this study is to determine the effect of remote ischemic preconditioning (RIPC) on blood pressure and its vascular protection effect among Chinese young healthy adults and primary hypertensive patients stage I.
Read the detailed description
Hypertension is one of the most common world-wide chronic diseases, and it is one of major independent risk factors of atherosclerotic cardiovascular diseases (ASCVD) especially among middle-aged and elderly. Recently, a study indicates that in a normotensive elderly without cardiovascular diseases history, continuous RIPC for 30 days lowers systolic blood pressure for 6 mmHg and diastolic blood pressure for 3 mmHg. Another study shows a 7-day RIPC intervention improves endothelium-dependent flow mediated dilation(FDM) and cutaneous vascular conductivity(CVC) in 13 healthy young males. In addition, studies demonstrate that microRNA-126 and microRNA-34a are endothelial specific microRNAs which are expressed in human PBMCs. MicroRNA-126 is responsible for keeping the integrity of vascular endothelial, promoting the proliferation, mobilization, and migration of endothelial progenitor cells(EPCs), reducing arterial intimal hyperplasia, and reduce adhesion of neutrophils to vascular endothelial. In contrast, microRNA-34a is related to the aging of endothelial cells, which is found over-expressed in senile endothelial cells. Together the investigators use microRNA-126 and microRNA-34a to explore whether RIPC produces vascular endothelial protection effect. In summary, the investigators propose a hypothesis that RIPC might have a blood pressure lowing effect and protect vascular function both in Chinese healthy young adults and primary hypertensive patients. The term "primary hypertension stage I" indicates those with blood pressures ranging from 140 to 159 mmHg systolic and/or 90 to 99 mmHg diastolic. Accumulating evidences suggest that subjects with primary hypertension stage I are associated with higher incidence of ASCVD. However, there is no available data to investigate a nonpharmacologic therapy for primary hypertension stage I until now, and there is no prospective, randomized, controlled, single-blind clinic trial to investigate the effect of RIPC on blood pressure and its vascular protection effect. The investigators hypothesize that RIPC may lower both SBP and DBP, and it improves vascular function in Chinese healthy young adults and subjects with primary hypertension stage I. To address these assumptions, the present study is designed to study the effect of RIPC on blood pressure and its vascular protection effect, using FMD, PWV, central arterial pressure, RHI(EndoPAT) and the quantification of microRNA-126 and microRNA-34a in peripheral blood monocyte(PBMC) as indicators among Chinese healthy young adults and primary hypertensive patients stage I over a 1-month follow-up period.
- Conditions
- Pressure; Brachial Plexus
- Being tested
- RIPC, Sham RIPC
- Keywords
- RIPC (remote ischemic preconditioning), primary hypertension stage I, vascular function, microRNA-126, microRNA-34a
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RIPCProcedure or surgery
Surround left upper limb with cuff, inflate cuff to 200mmHg and maintain 5 minutes, than deflate to 0mmHg. Change to right upper limb and repeat the procedure described above. Change back to left upper limb and repeat the same procedure. Perform once a day ( Thus 15 minutes a day).
Sham RIPCProcedure or surgery
Surround left upper limb with cuff, inflate cuff to 20mmHg and maintain 5 minutes, than deflate to 0mmHg. Change to right upper limb and repeat the procedure described above. Change back to left upper limb and repeat the same procedure. Perform once a day ( Thus 15 minutes a day).
| Study group | Role | What they receive |
|---|---|---|
| RIPC group | Experimental | Surround left upper limb with cuff, inflate cuff to 200 mmHg and maintain 5 minutes, than deflate to 0 mmHg. Change to right upper limb and repeat the procedure described above. Change back to left upper limb and repeat the same procedure. Perform once a day ( Thus 15 minutes a day). Receives: Procedure: RIPC |
| Sham RIPC group | Sham comparator | Surround left upper limb with cuff, inflate cuff to 20 mmHg and maintain 5 minutes, than deflate to 0 mmHg. Change to right upper limb and repeat the procedure described above. Change back to left upper limb and repeat the same procedure. Perform once a day ( Thus 15 minutes a day). Receives: Procedure: Sham RIPC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Systolic Blood Pressure at 1 month
systolic pressure lowers 6mmHg
Measured: Baseline; 1 week after RIPC; 1 month after RIPC
Change from Baseline in Diastolic Blood Pressure at 1 month
diastolic pressure lowers 3mmHg
Measured: Baseline; 1 week after RIPC; 1 month after RIPC
Secondary outcomes (6)
Artery elasticity
Brachia-ankle pulse wave velocity (baPWV)
Measured: Baseline; 1 week after RIPC; 1 month after RIPC
Vascular endothelial function - RHI(EndoPAT)
RHI
Measured: Baseline; 1 week after RIPC; 1 month after RIPC
Quantification of microRNA-126 and microRNA-34a in PBMC (peripheral blood mononuclear cell)
Measured: Baseline; 1 week after RIPC; 1 month after RIPC
Migration and adhesion function of endothelial progenitor cells (EPC)
Measured: Baseline; 1 week after RIPC; 1 month after RIPC
Endothelial function
Endothelium-dependent brachial artery flow-mediated dilation (FMD)
Measured: Baseline; 1 week after RIPC; 1 month after RIPC
Expression of CXC-chemokine receptor 4 and CXC-chemokine receptor 7 protein of EPC
Measured: Baseline; 1 week after RIPC; 1 month after RIPC
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2015 (estimated)
- Study startFeb 2015
- Primary completionAug 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure; Brachial PlexusStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital, Sun Yat-Sen 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiao Haipeng, First Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Tao Jun, phD, Principal investigator, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02414997
- Sponsor's protocol ID
- XHaipeng
- Status last verified
- Apr 2015
- First submitted
- 27 Mar 2015
- Last updated
- 13 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Remote Ischemic Preconditioning (RIPC) on Blood Pressure and Its Vascular Protection Effect Among Chinese Young Healthy Adults and Primary Hypertensive Patients Stage I
- ClinicalTrials.gov ID
- NCT02414997
- Acronym / sponsor ID
- XHaipeng
- Conditions
- Pressure; Brachial Plexus
- Keywords
- RIPC (remote ischemic preconditioning), primary hypertension stage I, vascular function, microRNA-126, microRNA-34a
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 13 Apr 2015 (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 effect of remote ischemic preconditioning (RIPC) on blood pressure and its vascular protection effect among Chinese young healthy adults and primary hypertensive patients stage I.
Detailed description
Hypertension is one of the most common world-wide chronic diseases, and it is one of major independent risk factors of atherosclerotic cardiovascular diseases (ASCVD) especially among middle-aged and elderly. Recently, a study indicates that in a normotensive elderly without cardiovascular diseases history, continuous RIPC for 30 days lowers systolic blood pressure for 6 mmHg and diastolic blood pressure for 3 mmHg. Another study shows a 7-day RIPC intervention improves endothelium-dependent flow mediated dilation(FDM) and cutaneous vascular conductivity(CVC) in 13 healthy young males. In addition, studies demonstrate that microRNA-126 and microRNA-34a are endothelial specific microRNAs which are expressed in human PBMCs. MicroRNA-126 is responsible for keeping the integrity of vascular endothelial, promoting the proliferation, mobilization, and migration of endothelial progenitor cells(EPCs), reducing arterial intimal hyperplasia, and reduce adhesion of neutrophils to vascular endothelial. In contrast, microRNA-34a is related to the aging of endothelial cells, which is found over-expressed in senile endothelial cells. Together the investigators use microRNA-126 and microRNA-34a to explore whether RIPC produces vascular endothelial protection effect. In summary, the investigators propose a hypothesis that RIPC might have a blood pressure lowing effect and protect vascular function both in Chinese healthy young adults and primary hypertensive patients. The term "primary hypertension stage I" indicates those with blood pressures ranging from 140 to 159 mmHg systolic and/or 90 to 99 mmHg diastolic. Accumulating evidences suggest that subjects with primary hypertension stage I are associated with higher incidence of ASCVD. However, there is no available data to investigate a nonpharmacologic therapy for primary hypertension stage I until now, and there is no prospective, randomized, controlled, single-blind clinic trial to investigate the effect of RIPC on blood pressure and its vascular protection effect. The investigators hypothesize that RIPC may lower both SBP and DBP, and it improves vascular function in Chinese healthy young adults and subjects with primary hypertension stage I. To address these assumptions, the present study is designed to study the effect of RIPC on blood pressure and its vascular protection effect, using FMD, PWV, central arterial pressure, RHI(EndoPAT) and the quantification of microRNA-126 and microRNA-34a in peripheral blood monocyte(PBMC) as indicators among Chinese healthy young adults and primary hypertensive patients stage I over a 1-month follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RIPC group | Experimental | Procedure: RIPCSurround left upper limb with cuff, inflate cuff to 200 mmHg and maintain 5 minutes, than deflate to 0 mmHg. Change to right upper limb and repeat the procedure described above. Change back to left upper limb and repeat the same procedure. Perform once a day ( Thus 15 minutes a day). |
| Sham RIPC group | Sham comparator | Procedure: Sham RIPCSurround left upper limb with cuff, inflate cuff to 20 mmHg and maintain 5 minutes, than deflate to 0 mmHg. Change to right upper limb and repeat the procedure described above. Change back to left upper limb and repeat the same procedure. Perform once a day ( Thus 15 minutes a day). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects range from 18 to 80 years old.
- Blood pressure is normal or primary hypertension stage I(systolic blood pressure 140 to 159 mmHg and/or diastolic blood pressure 90 to 99 mmHg).
- No history of smoking( smoking can eliminate the effect of RIPC) or quit smoking for at least 1 years.
- No intake of caffeine or caffeine-containing substances during the process of this trial(caffeine can eliminate the effect of RIPC).
- Provide informed consent and willingness to cooperate with the study protocol.
Key exclusion criteria (7 listed)
- Less than 18 years old or above 80 years old.
- Secondary hypertension.
- Pregnant or lactating females.
- Systemic diseases such as diabetes, HIV/AIDS, liver disease, chronic renal failure, tuberculosis, and autoimmune diseases.
- Medical history of cardiovascular disease: acute myocardial infarct, stable angina, unstable angina, heart failure, atrial fibrillation, atrioventricular blockade, peripheral vascular disease or cerebrovascular accident.
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 |
|---|---|---|
| RIPCSurround left upper limb with cuff, inflate cuff to 200mmHg and maintain 5 minutes, than deflate to 0mmHg. Change to right upper limb and repeat the procedure described above. Change back to left upper limb and repeat the same procedure. Perform once a day ( Thus 15 minutes a day). | Procedure or surgery | RIPC group |
| Sham RIPCSurround left upper limb with cuff, inflate cuff to 20mmHg and maintain 5 minutes, than deflate to 0mmHg. Change to right upper limb and repeat the procedure described above. Change back to left upper limb and repeat the same procedure. Perform once a day ( Thus 15 minutes a day). | Procedure or surgery | Sham RIPC group |
Primary outcome
Change from Baseline in Systolic Blood Pressure at 1 month
Time frame: Baseline; 1 week after RIPC; 1 month after RIPC
systolic pressure lowers 6mmHg
Change from Baseline in Diastolic Blood Pressure at 1 month
Time frame: Baseline; 1 week after RIPC; 1 month after RIPC
diastolic pressure lowers 3mmHg
6 secondary outcomes
Artery elasticity
Time frame: Baseline; 1 week after RIPC; 1 month after RIPC
Vascular endothelial function - RHI(EndoPAT)
Time frame: Baseline; 1 week after RIPC; 1 month after RIPC
Quantification of microRNA-126 and microRNA-34a in PBMC (peripheral blood mononuclear cell)
Time frame: Baseline; 1 week after RIPC; 1 month after RIPC
Migration and adhesion function of endothelial progenitor cells (EPC)
Time frame: Baseline; 1 week after RIPC; 1 month after RIPC
Endothelial function
Time frame: Baseline; 1 week after RIPC; 1 month after RIPC
Expression of CXC-chemokine receptor 4 and CXC-chemokine receptor 7 protein of EPC
Time frame: Baseline; 1 week after RIPC; 1 month after RIPC
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2015.
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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.
Tao Jun, phD principal investigator
First Affiliated Hospital, Sun Yat-Sen University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing RIPC in people with Pressure; Brachial Plexus, run by First Affiliated Hospital, Sun Yat-Sen University.
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 7 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: status not confirmed, as of the sponsor's last update on 13 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Change from Baseline in Systolic Blood Pressure at 1 month (time frame: Baseline; 1 week after RIPC; 1 month after RIPC). 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 13 Apr 2015.