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Trial record 3 of 15689 for:    coronary heart disease
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The Study of MicroRNA Genomics of Blood Stasis Syndrome and of Coronary Heart Disease

This study is currently recruiting participants.
Verified May 2012 by Guang'an Men Hospital
Sponsor:
Information provided by (Responsible Party):
Guang'an Men Hospital
ClinicalTrials.gov Identifier:
NCT01615003
First received: May 28, 2012
Last updated: June 6, 2012
Last verified: May 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Coronary Heart Disease
Unstable Angina
Blood Stasis Syndrome
 Drug: Xuesaitong soft capsule
Drug: Xuesaitong soft capsule Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Analysis of Blood Stasis Syndromeand of Coronary Heart Disease Related MicroRNA Genomics and Target Gene Regulatory Networks

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Guang'an Men Hospital:

Primary Outcome Measures:
  • the change of Cycle threshold of relational microRNA in coronary artery disease with unstable angina [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    The change of Cycle threshold of relational microRNA in coronary artery disease with unstable angina by real RT-PCR.


Estimated Enrollment: 70
Study Start Date: May 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Xuesaitong soft capsule group
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
Xuesaitong soft capsule, soft capsule, Ingredients:PNS, Specification:0.33 per bag, once take two pills and twice a day during a month.
Placebo Comparator: control group
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
Xuesaitong soft capsule Placebo, soft capsule, once take two pills and twice a day during a month.

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01615003

Contacts
Contact: Fei Teng, master 13581985462 echo-teng@126.com

Locations
China, Beijing
Guang'an men Hispital Recruiting
Beijing, Beijing, China, 100000
Contact: Fei Teng, master     13581985462     echo-teng@126.com    
Contact: Gui Yu, master     13488835663        
Principal Investigator: Jie Wang, doctor            
Sponsors and Collaborators
Guang'an Men Hospital
  More Information

No publications provided

Responsible Party: Guang'an Men Hospital
ClinicalTrials.gov Identifier: NCT01615003     History of Changes
Other Study ID Numbers: NNSF81173116
Study First Received: May 28, 2012
Last Updated: June 6, 2012
Health Authority: China: Ministry of Health

Keywords provided by Guang'an Men Hospital:
MicroRNA
coronary heart disease
unstable angina
blood stasis syndrome
Xuesaitong soft capsule

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases
 Arterial Occlusive Diseases
Angina, Unstable
Blind Loop Syndrome
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms
Malabsorption Syndromes
Arteriosclerosis

ClinicalTrials.gov processed this record on May 23, 2013