The Study of MicroRNA Genomics of Blood Stasis Syndrome and of Coronary Heart Disease

Coronary Heart Disease Clinical Trial

Official title:

The Analysis of Blood Stasis Syndromeand of Coronary Heart Disease Related MicroRNA Genomics and Target Gene Regulatory Networks

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01615003
• Other study ID #: NNSF81173116
• Status: Recruiting
• Phase: Phase 2
• First received: May 28, 2012
• Last updated: January 12, 2014
• Start date: May 2012
• Est. completion date: December 2014

Study information

• Verified date: January 2014
• Source: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Contact: Fei Teng, master
• Phone: 13581985462
• Email: echo-teng[@]126.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

In this study, typical cases of blood stasis syndrome of coronary heart disease are selected, by using microRNA chip, cDNA microarray and other bioinformatics technologies to filter and verify related miRNA and its target gene of Coronary Heart disease. Meanwhile, intervene by Xuesaitong soft capsules to investigate related miRNA and its target gene of Coronary Heart disease.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of coronary angiography unstable angina

• Clinical diagnosis of unstable angina

• Age of 30 to 75 years old

• Not use thrombolysis, dilate coronary drugs within two weeks

• Tongue dark

• Sign the consent

Exclusion Criteria:

• Severe valvular heart disease

• Insulin-dependent diabetes

• mental disease

• Combined with severe liver, kidney, hematopoietic system disorder

• Patients with malignant tumors

• Pregnancy or breast-feeding women

• Recent history of trauma

• Drug allergy

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angina, Unstable
• Blind Loop Syndrome
• Blood Stasis Syndrome
• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia
• Unstable Angina

Intervention

Drug:
• Xuesaitong soft capsule
Xuesaitong soft capsule, soft capsule, Ingredients:PNS, Specification:0.33 per bag, once take two pills and twice a day during a month.
• Xuesaitong soft capsule Placebo
Xuesaitong soft capsule Placebo, soft capsule, once take two pills and twice a day during a month.

Locations

Country	Name	City	State
China	Guang'an men Hispital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the change of Cycle threshold of relational microRNA in coronary artery disease with unstable angina	The change of Cycle threshold of relational microRNA in coronary artery disease with unstable angina by real RT-PCR.	1 month	Yes