Cohort Study on Treatment of Cardiovascular Diseases With Traditional Chinese Medicine (CSCD-TCM plus)

March 25, 2022 updated by: Lin Li, Tianjin University of Traditional Chinese Medicine
This is a cohort study performed in patients with cardiovascular diaeases who were treated with oral Chinese medicine and Western medicine. Collect indicators such as the incidence of cardiovascular events, all due to readmission, all due to death. To hospital using clinical samples to detect genomics, proteomics, metabolomics, intestinal flora and sclerotia.To explore the clinical efficacy of Chinese patent medicine in the treatment of cardiovascular diseases, and provide reliable data support for its clinical application.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

20000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Tianjin, China
        • Recruiting
        • Tianjin University of Traditional Chinese Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The collaboration network of coronary heart disease research medical units formed by the research group, including The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, The Second Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin Chest Hospital, Tianjin Hospital of ITCWM Nankai Hospital and Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital#a total of 6 hospitals.

Description

Inclusion Criteria:

All patients admitted to the Department of Cardiovascular Medicine at The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, The Second Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin Chest Hospital, Tianjin Hospital of ITCWM Nankai Hospital and Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital were considered for inclusion in this study, and all Western medical diagnoses were identified and classified according to the International Classification of Diseases, 11th Revision (ICD-11).

Exclusion Criteria:

No exclusion criteria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Exposed group
Western medicine treatment with Chinese medicine treatmen
Drug: Chinese patent medicine
Shexiang Baoxin Pill, Tongxinluo Capsule, Tongmai Yangxin Pill, Xuefu Zhuyu Capsule, Qishen Yiqi Dropping Pill, etc.
Non-exposed group
Western medicine treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiovascular Events Cardiovascular Events Cardiovascular Events
Time Frame: one year
Non-fatal myocardial infarction, non-fatal ischemic stroke, unplanned hemodynamic reconstruction.
one year
All due to readmission
Time Frame: one year
Readmission for cardiovascular events and readmission for other reasons.
one year
All due to death
Time Frame: one year
Cardiac death and death from other causes.
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tianjin University of Traditional Chinese Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2021

Primary Completion (Anticipated)

April 1, 2024

Study Completion (Anticipated)

November 1, 2031

Study Registration Dates

First Submitted

March 25, 2022

First Submitted That Met QC Criteria

March 25, 2022

First Posted (Actual)

April 4, 2022

Study Record Updates

Last Update Posted (Actual)

April 4, 2022

Last Update Submitted That Met QC Criteria

March 25, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSCD-TCM plus

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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