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The Effect of Remote Ischemic Preconditioning (RIPC) on Blood Pressure and Its Vascular Protection Effect

Primary Purpose

Pressure; Brachial Plexus

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
RIPC
Sham RIPC
Sponsored by
First Affiliated Hospital, Sun Yat-Sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pressure; Brachial Plexus focused on measuring RIPC (remote ischemic preconditioning), primary hypertension stage I, vascular function, microRNA-126, microRNA-34a

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    RIPC group

    Sham RIPC group

    Arm Description

    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).

    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).

    Outcomes

    Primary Outcome Measures

    Change from Baseline in Systolic Blood Pressure at 1 month
    systolic pressure lowers 6mmHg
    Change from Baseline in Diastolic Blood Pressure at 1 month
    diastolic pressure lowers 3mmHg

    Secondary Outcome Measures

    Artery elasticity
    Brachia-ankle pulse wave velocity (baPWV)
    Vascular endothelial function - RHI(EndoPAT)
    RHI
    Quantification of microRNA-126 and microRNA-34a in PBMC (peripheral blood mononuclear cell)
    Migration and adhesion function of endothelial progenitor cells (EPC)
    Endothelial function
    Endothelium-dependent brachial artery flow-mediated dilation (FMD)
    Expression of CXC-chemokine receptor 4 and CXC-chemokine receptor 7 protein of EPC

    Full Information

    First Posted
    March 27, 2015
    Last Updated
    April 8, 2015
    Sponsor
    First Affiliated Hospital, Sun Yat-Sen University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02414997
    Brief Title
    The Effect of Remote Ischemic Preconditioning (RIPC) on Blood Pressure and Its Vascular Protection Effect
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 2015 (undefined)
    Primary Completion Date
    August 2016 (Anticipated)
    Study Completion Date
    December 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    First Affiliated Hospital, Sun Yat-Sen University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pressure; Brachial Plexus
    Keywords
    RIPC (remote ischemic preconditioning), primary hypertension stage I, vascular function, microRNA-126, microRNA-34a

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    RIPC group
    Arm Type
    Experimental
    Arm Description
    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).
    Arm Title
    Sham RIPC group
    Arm Type
    Sham Comparator
    Arm Description
    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).
    Intervention Type
    Procedure
    Intervention Name(s)
    RIPC
    Intervention Description
    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).
    Intervention Type
    Procedure
    Intervention Name(s)
    Sham RIPC
    Intervention Description
    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).
    Primary Outcome Measure Information:
    Title
    Change from Baseline in Systolic Blood Pressure at 1 month
    Description
    systolic pressure lowers 6mmHg
    Time Frame
    Baseline; 1 week after RIPC; 1 month after RIPC
    Title
    Change from Baseline in Diastolic Blood Pressure at 1 month
    Description
    diastolic pressure lowers 3mmHg
    Time Frame
    Baseline; 1 week after RIPC; 1 month after RIPC
    Secondary Outcome Measure Information:
    Title
    Artery elasticity
    Description
    Brachia-ankle pulse wave velocity (baPWV)
    Time Frame
    Baseline; 1 week after RIPC; 1 month after RIPC
    Title
    Vascular endothelial function - RHI(EndoPAT)
    Description
    RHI
    Time Frame
    Baseline; 1 week after RIPC; 1 month after RIPC
    Title
    Quantification of microRNA-126 and microRNA-34a in PBMC (peripheral blood mononuclear cell)
    Time Frame
    Baseline; 1 week after RIPC; 1 month after RIPC
    Title
    Migration and adhesion function of endothelial progenitor cells (EPC)
    Time Frame
    Baseline; 1 week after RIPC; 1 month after RIPC
    Title
    Endothelial function
    Description
    Endothelium-dependent brachial artery flow-mediated dilation (FMD)
    Time Frame
    Baseline; 1 week after RIPC; 1 month after RIPC
    Title
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Tao Jun, phD
    Organizational Affiliation
    First Affiliated Hospital, Sun Yat-Sen University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    The Effect of Remote Ischemic Preconditioning (RIPC) on Blood Pressure and Its Vascular Protection Effect

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