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

NCT01615003 | Unknown Phase 2 DMC

• 1 other identifier: NNSF81173116
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Heart Disease; Unstable Angina; Blood Stasis Syndrome

Keywords

MicroRNA; coronary heart disease; unstable angina; blood stasis syndrome; Xuesaitong soft capsule

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Xuesaitong soft capsule group

EXPERIMENTAL

Patients who confirmed by coronary angiography and diagnosed blood stasis syndrome of coronary heart disease are given conventional Western medicine treatment and Xuesaitong soft capsule.

Drug: Xuesaitong soft capsule

control group

PLACEBO COMPARATOR

Patients who confirmed by coronary angiography and diagnosed blood stasis syndrome of coronary heart disease are given conventional Western medicine treatment and placebo.

Drug: Xuesaitong soft capsule Placebo

Interventions

Xuesaitong soft capsule DRUG

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 group

Xuesaitong soft capsule Placebo DRUG

Xuesaitong soft capsule Placebo, soft capsule, once take two pills and twice a day during a month.

control group

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Guang'anmen Hospital of China Academy of Chinese Medical Sciences: lead

Study Sites (1)

Guang'an men Hispital

Beijing, Beijing Municipality, 100000, China

RECRUITING

MeSH Terms

Conditions

Coronary Disease; Angina, Unstable

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Fei Teng, master

CONTACT

13581985462; echo-teng@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2012
• First Posted: June 8, 2012
• Study Start: May 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 14, 2014

Record last verified: 2014-01

Locations

CN (1)