NCT01118000

Brief Summary

Numerous studies Have shown that limb ischemic preconditioning can protect vital organs (including the heart) from ischemia-reperfusion injury,which has a broad application prospect.But its mechanism is still unclear. Evidence showed that humoral mechanisms may play an important role. This study was carried out on the limb ischemic preconditioning in healthy volunteers, collected their serum at different time points before and after treatment,classified and identified the serum proteins during different periods of limb ischemic preconditioning,by using methods including high abundant protein removal,Two-dimensional electrophoresis chromatography and mass spectrometry,then analysed activation and synthesis of the proteins in order to search for the proteins or peptides whose synthesis was activated by ischemic preconditioning. This study will be the first systemic explore of the changes in serum proteins of limb ischemic preconditioning in human body,and lay theoretical basis for the clinical application of limb ischemic preconditioning and for further explore of its humoral mechanism,thus provide clues for searching for protein or peptide having protective effects for organs.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 26, 2010

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 6, 2010

Completed
Last Updated

July 28, 2010

Status Verified

April 1, 2010

Enrollment Period

2 months

First QC Date

April 26, 2010

Last Update Submit

July 27, 2010

Conditions

Keywords

ischemic preconditioning,serum proteins,human

Outcome Measures

Primary Outcomes (1)

  • Transient limb ischemia would change expression of several serum proteins in humans,indicating a humoral mechanism for its organ protection.

    Proteomics analysis of the serum proteins.

    two years

Secondary Outcomes (1)

  • A questionnaire study of the acceptability of transient limb ischemia in healthy conscious subjects.

    one year

Study Arms (1)

limb ischemia preconditioning

EXPERIMENTAL

limb ischemic preconditioning consists of three 5-min cycles of left upper limb ischemia induced by a blood pressure cuff placed on the left upper arm and inflated to 200 mmHg,with an intervention 5-min of reperfusion during which the cuff was deflated.

Procedure: limb ischemia preconditioning

Interventions

limb ischemic preconditioning consists of three 5-min cycles of left upper limb ischemia induced by a blood pressure cuff placed on the left upper arm and inflated to 200 mmHg,with an intervention 5-min of reperfusion during which the cuff was deflated.

Also known as: remote ischemia preconditioning
limb ischemia preconditioning

Eligibility Criteria

Age20 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy volunteers aging 20-30 years old
  • no cardiac,hepatic or renal,peripheral vascular diseases
  • be willing to enter our study and sign an written informed consent

You may not qualify if:

  • younger than 20 years old or older than 30 years old
  • having cardiac,hepatic or renal,peripheral vascular diseases
  • refuse to enter our study or sign an written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

proteomics lab of Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Location

Related Links

Study Officials

  • Jin S qing, Doctor

    Sixth Affiliated Hospital, Sun Yat-sen University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 26, 2010

First Posted

May 6, 2010

Study Start

September 1, 2009

Primary Completion

November 1, 2009

Study Completion

March 1, 2010

Last Updated

July 28, 2010

Record last verified: 2010-04

Locations