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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01804283
Other study ID # CmiR-001
Secondary ID
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. completion date
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


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
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