Study on the Cardioprotection and Humoral Mechanism of Limb Ischemia Preconditioning

Ischemic Preconditioning Clinical Trial

Official title:

Study on the Cardioprotection and Humoral Mechanism of Limb Ischemia Preconditioning

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01118000
• Other study ID #: GDNSFC7001664
• Status: Completed
• Phase: N/A
• First received: April 26, 2010
• Last updated: July 27, 2010
• Start date: September 2009
• Est. completion date: March 2010

Study information

• Verified date: April 2010
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2010
• Est. primary completion date: November 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 30 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ischemic Preconditioning

Intervention

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.

Locations

Country	Name	City	State
China	proteomics lab of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	one year	No

External Links

•   Effect of remote ischaemic preconditioning on myocardial injury in patients undergoing coronary artery bypass graft surgery: a randomised controlled trial.
•   Ischemic preconditioning prevents endothelial injury and systemic neutrophil activation during ischemia-reperfusion in humans
•   PUMED