Study on the Cardioprotection and Humoral Mechanism of Limb Ischemia Preconditioning
Primary Purpose
Ischemic Preconditioning
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
limb ischemia preconditioning
Sponsored by

About this trial
This is an interventional treatment trial for Ischemic Preconditioning focused on measuring ischemic preconditioning,serum proteins,human
Eligibility Criteria
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
Sites / Locations
- proteomics lab of Sun Yat-sen University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
limb ischemia preconditioning
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
A questionnaire study of the acceptability of transient limb ischemia in healthy conscious subjects.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01118000
Brief Title
Study on the Cardioprotection and Humoral Mechanism of Limb Ischemia Preconditioning
Official Title
Study on the Cardioprotection and Humoral Mechanism of Limb Ischemia Preconditioning
Study Type
Interventional
2. Study Status
Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
We aim to assess whether limb ischemic preconditioning protects remote tissue or organs through a humoral mechanism.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Preconditioning
Keywords
ischemic preconditioning,serum proteins,human
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
limb ischemia preconditioning
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
limb ischemia preconditioning
Other Intervention Name(s)
remote ischemia preconditioning
Intervention Description
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.
Primary Outcome Measure Information:
Title
Transient limb ischemia would change expression of several serum proteins in humans,indicating a humoral mechanism for its organ protection.
Description
Proteomics analysis of the serum proteins.
Time Frame
two years
Secondary Outcome Measure Information:
Title
A questionnaire study of the acceptability of transient limb ischemia in healthy conscious subjects.
Description
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.
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin S qing, Doctor
Organizational Affiliation
Sixth Affiliated Hospital, Sun Yat-sen University
Official's Role
Study Director
Facility Information:
Facility Name
proteomics lab of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
12. IPD Sharing Statement
Links:
URL
http://www.ncbi.nlm.nih.gov/sites/entrez
Description
PUMED
URL
http://www.ncbi.nlm.nih.gov/pubmed/17707752
Description
Effect of remote ischaemic preconditioning on myocardial injury in patients undergoing coronary artery bypass graft surgery: a randomised controlled trial.
URL
http://www.ncbi.nlm.nih.gov/sites/entrez
Description
Ischemic preconditioning prevents endothelial injury and systemic neutrophil activation during ischemia-reperfusion in humans
Learn more about this trial
Study on the Cardioprotection and Humoral Mechanism of Limb Ischemia Preconditioning
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