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

• Sponsor: Tianjin University of Traditional Chinese Medicine (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05309343
• Collaborator: (none)
• Enrollment: 20,000
• Location: 1
• Anticipated Duration (Months): 120
• Patients Per Site Per Month: 166.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Diseases	Drug: Chinese patent medicine

Study Design

• Study Type: Observational
• Anticipated Enrollment: 20000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Cohort Study on Treatment of Cardiovascular Diseases With Traditional Chinese Medicine
• Actual Study Start Date: Nov 1, 2021
• Anticipated Primary Completion Date: Apr 1, 2024
• Anticipated Study Completion Date: Nov 1, 2031

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Cardiovascular Events Cardiovascular Events Cardiovascular Events [one year]

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

2. All due to readmission [one year]

   Readmission for cardiovascular events and readmission for other reasons.

3. All due to death [one year]

   Cardiac death and death from other causes.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tianjin University of Traditional Chinese Medicine	Tianjin		China

Sponsors and Collaborators

• Tianjin University of Traditional Chinese Medicine

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lin Li, researcher, Tianjin University of Traditional Chinese Medicine
• ClinicalTrials.gov Identifier: NCT05309343
• Other Study ID Numbers: CSCD-TCM plus
• First Posted: Apr 4, 2022
• Last Update Posted: Apr 4, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Cardiovascular Diseases

Study Results

No Results Posted as of Apr 4, 2022