Study on the Cardioprotection and Humoral Mechanism of Limb Ischemia Preconditioning

Not Applicable

Completed

• Conditions: Ischemic Preconditioning
• Interventions: Procedure: limb ischemia preconditioning

• Registration Number: NCT01118000
• Lead Sponsor: Sun Yat-sen University

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.

Study Timeline

• Study Start: 2009-09
• Primary Completion: 2009-11
• Study Completion: 2010-03
• Status Verified: 2010-04
• Study First Submitted: 2010-04-26
• Study First Submitted QC: 2010-05-04
• Study First Posted: 2010-05-06
• Last Update Submitted: 2010-07-27
• Last Update Posted: 2010-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
limb ischemia preconditioning	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
A questionnaire study of the acceptability of transient limb ischemia in healthy conscious subjects.	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.

Trial Locations

Locations (1)

proteomics lab of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China