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Study on the Cardioprotection and Humoral Mechanism of Limb Ischemia Preconditioning

This study has been completed.
Sponsor:
Information provided by:
Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01118000
First received: April 26, 2010
Last updated: July 27, 2010
Last verified: April 2010
History of Changes
  Purpose

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.


Condition Intervention
Ischemic Preconditioning
 Procedure: limb ischemia preconditioning

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study on the Cardioprotection and Humoral Mechanism of Limb Ischemia Preconditioning

Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • Transient limb ischemia would change expression of several serum proteins in humans,indicating a humoral mechanism for its organ protection. [ Time Frame: two years ] [ Designated as safety issue: No ]
    Proteomics analysis of the serum proteins.


Secondary Outcome Measures:
  • A questionnaire study of the acceptability of transient limb ischemia in healthy conscious subjects. [ Time Frame: one year ] [ Designated as safety issue: No ]
    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.


Enrollment: 60
Study Start Date: September 2009
Study Completion Date: March 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: remote ischemia preconditioning

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   20 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01118000

Locations
China, Guangdong
proteomics lab of Sun Yat-sen University
Guangzhou, Guangdong, China, 510080
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Study Director: Jin S qing, Doctor the Sixth Affiliated Hospital of Sun Yat-sen University
  More Information

Additional Information:
PUMED  This link exits the ClinicalTrials.gov site
Effect of remote ischaemic preconditioning on myocardial injury in patients undergoing coronary artery bypass graft surgery: a randomised controlled trial.  This link exits the ClinicalTrials.gov site
Natural Science Fund Committee  This link exits the ClinicalTrials.gov site
The effects of repetitive limb ischemia on physiological variables and the plasma concentration of NO, NOS in healthy human subjects  This link exits the ClinicalTrials.gov site
Ischemic preconditioning prevents endothelial injury and systemic neutrophil activation during ischemia-reperfusion in humans  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Guangdong Natural Science fund Committee
ClinicalTrials.gov Identifier: NCT01118000     History of Changes
Other Study ID Numbers: GDNSFC7001664
Study First Received: April 26, 2010
Last Updated: July 27, 2010
Health Authority: China: Ethics Committee

Keywords provided by Sun Yat-sen University:
ischemic preconditioning,serum proteins,human

Additional relevant MeSH terms:
Ischemia
Pathologic Processes

ClinicalTrials.gov processed this record on June 17, 2013