NCT02414997

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Feb 2015

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 27, 2015

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 13, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

April 13, 2015

Status Verified

April 1, 2015

Enrollment Period

1.5 years

First QC Date

March 27, 2015

Last Update Submit

April 8, 2015

Conditions

Pressure; Brachial Plexus

Keywords

RIPC (remote ischemic preconditioning)primary hypertension stage Ivascular functionmicroRNA-126microRNA-34a

Outcome Measures

Primary Outcomes (2)

  • Change from Baseline in Systolic Blood Pressure at 1 month

    systolic pressure lowers 6mmHg

    Baseline; 1 week after RIPC; 1 month after RIPC

  • Change from Baseline in Diastolic Blood Pressure at 1 month

    diastolic pressure lowers 3mmHg

    Baseline; 1 week after RIPC; 1 month after RIPC

Secondary Outcomes (6)

  • Artery elasticity

    Baseline; 1 week after RIPC; 1 month after RIPC

  • Vascular endothelial function - RHI(EndoPAT)

    Baseline; 1 week after RIPC; 1 month after RIPC

  • Quantification of microRNA-126 and microRNA-34a in PBMC (peripheral blood mononuclear cell)

    Baseline; 1 week after RIPC; 1 month after RIPC

  • Migration and adhesion function of endothelial progenitor cells (EPC)

    Baseline; 1 week after RIPC; 1 month after RIPC

  • Endothelial function

    Baseline; 1 week after RIPC; 1 month after RIPC

  • +1 more secondary outcomes

Study Arms (2)

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).

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).

Procedure: Sham RIPC

Interventions

RIPCPROCEDURE

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).

RIPC group
Sham RIPCPROCEDURE

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).

Sham RIPC group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Essential Hypertension

Condition Hierarchy (Ancestors)

HypertensionVascular DiseasesCardiovascular Diseases

Study Officials

  • Tao Jun, phD

    First Affiliated Hospital, Sun Yat-Sen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
president

Study Record Dates

First Submitted

March 27, 2015

First Posted

April 13, 2015

Study Start

February 1, 2015

Primary Completion

August 1, 2016

Study Completion

December 1, 2016

Last Updated

April 13, 2015

Record last verified: 2015-04