Cardiovascular DiseasesCSCD-TCM plusNCT05309343
Cohort Study on Treatment of Cardiovascular Diseases With Traditional Chinese Medicine
An observational study of Cardiovascular Diseases, run by Tianjin University of Traditional Chinese Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Chinese patent medicine
- Type of treatment
- Pill or oral medicine
- How many people
- 20,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2021to 1 Nov 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- No exclusion criteria.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tianjin University of Traditional Chinese Medicine
Tianjin
Lin Li, Master, +8613820396963, llbianji@163.com
About this study
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.
- Conditions
- Cardiovascular Diseases
- Being tested
- Chinese patent medicine
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chinese patent medicineDrug
Shexiang Baoxin Pill, Tongxinluo Capsule, Tongmai Yangxin Pill, Xuefu Zhuyu Capsule, Qishen Yiqi Dropping Pill, etc.
| Study group | Role | What they receive |
|---|---|---|
| Exposed group | Western medicine treatment with Chinese medicine treatmen Receives: Drug: Chinese patent medicine | |
| Non-exposed group | Western medicine treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular Events Cardiovascular Events Cardiovascular Events
Non-fatal myocardial infarction, non-fatal ischemic stroke, unplanned hemodynamic reconstruction.
Measured: one year
All due to readmission
Readmission for cardiovascular events and readmission for other reasons.
Measured: one year
All due to death
Cardiac death and death from other causes.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study start1 Nov 2021
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Nov 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lin Li, Tianjin University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05309343
- Sponsor's protocol ID
- CSCD-TCM plus
- Acronym
- CSCD-TCM plus
- Status last verified
- Mar 2022
- First submitted
- 25 Mar 2022
- Last updated
- 4 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 37919791
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Study on Treatment of Cardiovascular Diseases With Traditional Chinese Medicine
- ClinicalTrials.gov ID
- NCT05309343
- Acronym / sponsor ID
- CSCD-TCM plus / CSCD-TCM plus
- Conditions
- Cardiovascular Diseases
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Tianjin University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Nov 2031 (estimated)
- First posted
- 4 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposed group | – | Drug: Chinese patent medicineWestern medicine treatment with Chinese medicine treatmen |
| Non-exposed group | – | –Western medicine treatment |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- No exclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chinese patent medicineShexiang Baoxin Pill, Tongxinluo Capsule, Tongmai Yangxin Pill, Xuefu Zhuyu Capsule, Qishen Yiqi Dropping Pill, etc. | Drug | Exposed group |
Primary outcome
Cardiovascular Events Cardiovascular Events Cardiovascular Events
Time frame: one year
Non-fatal myocardial infarction, non-fatal ischemic stroke, unplanned hemodynamic reconstruction.
All due to readmission
Time frame: one year
Readmission for cardiovascular events and readmission for other reasons.
All due to death
Time frame: one year
Cardiac death and death from other causes.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2022.
- Derived from this study: PubMed 37919791Yang 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases, run by Tianjin University of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular Events Cardiovascular Events Cardiovascular Events (time frame: one year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05309343, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2022.