NCT02967718

Brief Summary

Coronary heart disease is still the major cause of death in China. Chinese medicine plays more and more important role in CHD prevention and treatment. Phlegm and blood stasis are its major pathological basis. Based on that, the investigator aims to evaluate the evolutionary process of CHD phlegm-blood stasis syndrome by large samples, multi-centre, cross-section observation combining with longitudinal tracking on-site survey method so as to guide the clinical treatment of CHD.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
13,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 18, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

November 22, 2016

Status Verified

November 1, 2016

Enrollment Period

6 months

First QC Date

November 16, 2016

Last Update Submit

November 20, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • all cause mortality

    6 months

Study Arms (6)

Control group

the healthy patients

Metabolic syndrome group

Include patients who are accordance with diagnostic criteria of metabolic syndrome

CHD stable stage group

Include patients who are accordance with diagnostic criteria of asymptomatic angina, stable angina or stable (more than 1 month) acute coronary syndrome

Acute coronary syndrome group

Include patients who are accordance with diagnostic criteria of unstable angina or non-ST-segment elevated myocardial infarction

PCI or CABG group

Include the patients who will undergo percutaneous coronary intervention of coronary artery bypass grafting

CHD heart failure group

Include the patients who suffered heart failure cause by CHD

Eligibility Criteria

Age35 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Healthy, metabolic or coronary heart disease people, whose age is between 35-85 years old, either female or male, without any inflammation, fever, trauma, burn or operation within 1 week.

You may qualify if:

  • Healthy or metabolism syndrome people
  • Clinical diagnosis of CHD stable stage or acute coronary disease or CHD heart failure

You may not qualify if:

  • Any inflammation, fever, trauma, burn or operation within 1 week
  • Obstructive pulmonary disease
  • Cerebral vascular disease
  • Severe renal or hepatic dysfunction
  • Malignant neoplasms
  • Hematopoietic system disease
  • Sever mental disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Integrative Hospital of Beijing

Beijin, Beijing Municipality, China

RECRUITING

Related Publications (1)

  • Zhang J, Tong H, Jiang L, Hu J. Dietary Patterns Associated With Heat Retention in Blood Vessel Syndrome (HRBVS) in Coronary Heart Disease: A Cross-Sectional Study. Int J Gen Med. 2025 Mar 5;18:1283-1294. doi: 10.2147/IJGM.S510507. eCollection 2025.

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum sample

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Central Study Contacts

Weiming Xu, Doctor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director of Institute of Basic Theory of Traditional Chinese Medicine

Study Record Dates

First Submitted

November 16, 2016

First Posted

November 18, 2016

Study Start

September 1, 2016

Primary Completion

March 1, 2017

Study Completion

December 1, 2017

Last Updated

November 22, 2016

Record last verified: 2016-11

Locations