Effects of Ischemic Postconditioning on MicroRNAs in Double Valve Replacement

Cardiopulmonary Bypass Clinical Trial

Official title:

Effects of Ischemic Postconditioning on Expression of Apoptosis-related MicroRNAs and Genes in Human Double Valve Replacement

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01804283
• Other study ID #: CmiR-001
• Status: Not yet recruiting
• Phase: N/A
• First received: February 23, 2013
• Last updated: March 3, 2013
• Start date: March 2013

Study information

• Verified date: March 2013
• Source: Central South University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

1. Cardiopulmonary bypass and cardioplegic arrest could regulate expression of microRNAs in patients undergoing double valve replacement (aortic and mitral).

2. The modulation of myocardial microRNAs by cardiopulmonary bypass and cardioplegic arrest may be rescued by ischemic postconditioning.

3. Downstream effectors would also be affected.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 8
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Consecutive eight patients with rheumatic heart valve disease undergoing elective double valve replacement(aortic and mitral)are considered for participation in this study.

Exclusion Criteria:

• insulin-dependent diabetes mellitus

• pulmonary, renal, or hepatic failure

• infective valve disease

• valve disease with coronary artery disease

• hypertension

• emergency and reoperations

• received aspirin,corticosteroids, or statin preoperatively

• received preoperative inotropic support

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cardiopulmonary Bypass
• Ischemia
• Ischemic Postconditioning

Intervention

Procedure:
• ischemic postconditioning
multiple brief ischemic-reperfusion episodes immediately after sustained ischemic insult Postconditioning was started at 30 s after aortic cross declamping, and the aorta was re-clamped for 30 s rendering global myocardial ischemia. Meanwhile aortic root suction was established during aortic re-clamping, and thereafter, the aortic clamp was released for 30 s for full myocardial reperfusion. The cycle was repeated three times after cardioplegic arrest.
• double valve replacement
The double valve replacement is a procedure in which surgery is used to replace diseased aortic and mitral heart valves.

Device:
• heart-lung machine
The heart-lung machine is commonly used in open heart surgery including double valve replacement to support the circulation during the operation.
• Aortic cross-clamp
a surgical instrument used in cardiac surgery to clamp the aorta

Locations

Country	Name	City	State
China	Xiangya Hospital	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Cardiac MicroRNA Expression	Samples were harvested from all the patients, respectively, before cardiopulmonary bypass and at 5 min after aortic de-clamping. Real-time quantitative stem-loop reverse transcription polymerase chain reaction assay was performed to detect the expression of microRNAs.	before cardiopulmonary bypass and at 5 min after aortic de-clamping	No
Secondary	Change from Baseline in Downstream Gene Expression	Expressions of messenger RNAs and proteins were quantified for genes which are regulated by above-detected microRNAs.	before cardiopulmonary bypass and at 5 min after aortic de-clamping	No