NCT05309343

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
20,000

participants targeted

Target at P75+ for all trials

Timeline
67mo left

Started Nov 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress45%
Nov 2021Nov 2031

Study Start

First participant enrolled

November 1, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 4, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
7.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2031

Expected
Last Updated

April 4, 2022

Status Verified

March 1, 2022

Enrollment Period

2.4 years

First QC Date

March 25, 2022

Last Update Submit

March 25, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • Cardiovascular Events Cardiovascular Events Cardiovascular Events

    Non-fatal myocardial infarction, non-fatal ischemic stroke, unplanned hemodynamic reconstruction.

    one year

  • All due to readmission

    Readmission for cardiovascular events and readmission for other reasons.

    one year

  • All due to death

    Cardiac death and death from other causes.

    one year

Study Arms (2)

Exposed group

Western medicine treatment with Chinese medicine treatmen

Drug: Chinese patent medicine

Non-exposed group

Western medicine treatment

Interventions

Shexiang Baoxin Pill, Tongxinluo Capsule, Tongmai Yangxin Pill, Xuefu Zhuyu Capsule, Qishen Yiqi Dropping Pill, etc.

Exposed group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin University of Traditional Chinese Medicine

Tianjin, China

RECRUITING

Related Publications (1)

  • Yang T, Zheng H, Pan G, Guo R, Liu F, Liu S, Tao S, Li L, Yang R, Yu C. Relationship between the circulating N-terminal pro B-type natriuretic peptide and the risk of carotid artery plaque in different glucose metabolic states in patients with coronary heart disease: a CSCD-TCM plus study in China. Cardiovasc Diabetol. 2023 Nov 2;22(1):299. doi: 10.1186/s12933-023-02015-y.

Biospecimen

Retention: SAMPLES WITH DNA

Blood, Urine, feces, saliva, tongue coating

MeSH Terms

Conditions

Cardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
researcher

Study Record Dates

First Submitted

March 25, 2022

First Posted

April 4, 2022

Study Start

November 1, 2021

Primary Completion

April 1, 2024

Study Completion (Estimated)

November 1, 2031

Last Updated

April 4, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will share

Locations