Study on the Cardioprotection and Humoral Mechanism of Limb Ischemia Preconditioning

July 27, 2010 updated by: Sun Yat-sen University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

We aim to assess whether limb ischemic preconditioning protects remote tissue or organs through a humoral mechanism.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • proteomics lab of Sun Yat-sen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: limb ischemia preconditioning
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
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.
Other Names:
  • remote ischemia preconditioning

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Transient limb ischemia would change expression of several serum proteins in humans,indicating a humoral mechanism for its organ protection.
Time Frame: two years
Proteomics analysis of the serum proteins.
two years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
A questionnaire study of the acceptability of transient limb ischemia in healthy conscious subjects.
Time Frame: one year
Transient limb ischemia as a remote ischemic preconditioning stimulus has been shown an effective and non-invasive strategy to protect remote tissue or organs from an extended ischemic event. But the acceptability of human subjects remains unknown. Our study aims to assess the acceptability of this transient limb ischemia protocol in healthy conscious subjects.
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

April 26, 2010

First Submitted That Met QC Criteria

May 4, 2010

First Posted (Estimate)

May 6, 2010

Study Record Updates

Last Update Posted (Estimate)

July 28, 2010

Last Update Submitted That Met QC Criteria

July 27, 2010

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GDNSFC7001664

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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