Atherosclerotic Heart Disease With Angina NosRCSCD-TCMNCT04026724
Retrospective Clinical Study on Adjuvant Treatment of Coronary Heart Disease Angina Pectoris With Chinese Patent Medicine
An observational study of Atherosclerotic Heart Disease With Angina Nos, run by Tianjin University of Traditional Chinese Medicine at 1 site in China.
Trial summary
A retrospective cohort study was performed in patients with angina pectoris who were treated with oral Chinese patent medicine and Western medicine.The hospital's medical record management system was used to collect symptoms of angina pectoris, dose and frequency of nitroglycerin use, clinical biochemical test and… Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Atherosclerotic Heart Disease With Angina Nos
- What is being tested?
- Chinese patent medicine
- Type of treatment
- Pill or oral medicine
- How many people
- 12,400 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2019to 1 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 35 to 75 years
- All sexes
- Adult, Older adult
Study population: The collaboration network of coronary heart disease research medical units formed by the research group, including the First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, the Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin Nankai Hospital, Tianjin Chest Hospital, Tianjin Medical University General Hospital, a total of 5 hospitals.
Who may be able to join
- Age 35-75 years old, gender is not limited;
- Admission time is September 1, 2014 - September 1, 1919;
- Patients with coronary heart disease and angina pectoris in the Department of Cardiology or Outpatient Department, the diagnosis of angina pectoris meets the diagnostic criteria of Western medicine and the standard of TCM syndrome differentiation;
- Patients who met the criteria for drug treatment, the exposed group was treated with traditional Chinese medicine combined with Western medicine, and the non-exposed group was treated with Western medicine alone.
Who cannot join
- Combined with other heart diseases, neurosis, menopausal syndrome, hyperthyroidism, cervical or vertebral artery type cervical spondylosis, gastro-oesophageal reflux disease or esophageal hiatus hernia may cause chest pain;
- patients with acute myocardial infarction, heart failure, myocarditis, cardiomyopathy, severe heart valve disease, liver failure or renal failure, malignant tumors and severe metabolic diseases, as well as patients with severe symptoms and uncontrollable angina;
- Pregnant women, lactating women or women of childbearing age who have birth requirements;
- Mental patients, or cognitive dysfunction;
- The investigator believes that there are other situations that are not suitable for the trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Tianjin University of Traditional Chinese Medicine
Tianjin, Tianjin Municipality, 300193
Chunquan Yu, Dr., 8622-59596309, ycq-4@163.com
About this study
Official title: Retrospective Cohort Study on Adjuvant Treatment of Coronary Heart Disease Angina Pectoris With Chinese Patent Medicine
A retrospective cohort study was performed in patients with angina pectoris who were treated with oral Chinese patent medicine and Western medicine.The hospital's medical record management system was used to collect symptoms of angina pectoris, dose and frequency of nitroglycerin use, clinical biochemical test and imaging examination.To explore the clinical efficacy of Chinese patent medicine in the treatment of coronary heart disease with angina pectoris, and provide reliable data support for its clinical application.
- Being tested
- Chinese patent medicine
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.
| Study group | Role | What they receive |
|---|---|---|
| Exposed group | Chinese patent medicine combined with western medicine routine treatment Receives: Drug: Chinese patent medicine | |
| Non-exposed group | Western medicine routine treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms of angina
Measured: one year
Dosage and frequency of use of nitroglycerin
Measured: one year
Clinical biochemical indicators test
Measured: one year
Film degree exam
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 posted19 Jul 2019
- Study start1 Sep 2019 (estimated)
- Primary completion1 Mar 2020 (estimated)
- Study completion1 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Atherosclerotic Heart Disease With Angina NosStudies 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
- Retrospective
- Enrolment
- 12,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chunquan Yu, Tianjin University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04026724
- Sponsor's protocol ID
- RCSCD-TCM
- Acronym
- RCSCD-TCM
- Status last verified
- Jul 2019
- First submitted
- 13 Jul 2019
- Last updated
- 22 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Lai Z, Liu Y, Huang M, Li L, Li Z, Su J, Pan G, Li B, Gao S, Yu C. Associations Between Atherosclerosis and Elevated Serum Alkaline Phosphatase in Patients With Coronary Artery Disease in an Inflammatory State. Heart Lung Circ. 2023 Sep;32(9):1096-1106. doi: 10.1016/j.hlc.2023.05.012. Epub 2023 Aug 5.
PubMed 37550157Wang J, Huang X, Fu C, Sheng Q, Liu P. Association between triglyceride glucose index, coronary artery calcification and multivessel coronary disease in Chinese patients with acute coronary syndrome. Cardiovasc Diabetol. 2022 Sep 16;21(1):187. doi: 10.1186/s12933-022-01615-4.
PubMed 36114495Yu L, Li Z, Yang R, Pan G, Cheng Q, He Y, Liu Y, Liu F, Ma M, Yang T, Wang Y, Su J, Zheng Y, Gao S, Xu Q, Li L, Yu C. Impaired Sensitivity to Thyroid Hormones Is Associated With Elevated Blood Glucose in Coronary Heart Disease. Front Endocrinol (Lausanne). 2022 Jun 15;13:895843. doi: 10.3389/fendo.2022.895843. eCollection 2022.
PubMed 35784545Su J, Li Z, Huang M, Wang Y, Yang T, Ma M, Ni T, Pan G, Lai Z, Li C, Li L, Yu C. Triglyceride glucose index for the detection of the severity of coronary artery disease in different glucose metabolic states in patients with coronary heart disease: a RCSCD-TCM study in China. Cardiovasc Diabetol. 2022 Jun 6;21(1):96. doi: 10.1186/s12933-022-01523-7.
PubMed 35668496
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Cohort Study on Adjuvant Treatment of Coronary Heart Disease Angina Pectoris With Chinese Patent Medicine
- ClinicalTrials.gov ID
- NCT04026724
- Acronym / sponsor ID
- RCSCD-TCM / RCSCD-TCM
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 12,400 participants (estimated)
- Lead sponsor
- Tianjin University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 1 Sep 2019 (estimated)
- Primary completion
- 1 Mar 2020 (estimated)
- Study completion
- 1 Sep 2020 (estimated)
- First posted
- 19 Jul 2019 (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.
A retrospective cohort study was performed in patients with angina pectoris who were treated with oral Chinese patent medicine and Western medicine.The hospital's medical record management system was used to collect symptoms of angina pectoris, dose and frequency of nitroglycerin use, clinical biochemical test and imaging examination.To explore the clinical efficacy of Chinese patent medicine in the treatment of coronary heart disease with angina pectoris, and provide reliable data support for its clinical application.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposed group | – | Drug: Chinese patent medicineChinese patent medicine combined with western medicine routine treatment |
| Non-exposed group | – | –Western medicine routine treatment |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The collaboration network of coronary heart disease research medical units formed by the research group, including the First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, the Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin Nankai Hospital, Tianjin Chest Hospital, Tianjin Medical University General Hospital, a total of 5 hospitals.
Key inclusion criteria (4 listed)
- Age 35-75 years old, gender is not limited;
- Admission time is September 1, 2014 - September 1, 1919;
- Patients with coronary heart disease and angina pectoris in the Department of Cardiology or Outpatient Department, the diagnosis of angina pectoris meets the diagnostic criteria of Western medicine and the standard of TCM syndrome differentiation;
- Patients who met the criteria for drug treatment, the exposed group was treated with traditional Chinese medicine combined with Western medicine, and the non-exposed group was treated with Western medicine alone.
Key exclusion criteria (5 listed)
- Combined with other heart diseases, neurosis, menopausal syndrome, hyperthyroidism, cervical or vertebral artery type cervical spondylosis, gastro-oesophageal reflux disease or esophageal hiatus hernia may cause chest pain;
- patients with acute myocardial infarction, heart failure, myocarditis, cardiomyopathy, severe heart valve disease, liver failure or renal failure, malignant tumors and severe metabolic diseases, as well as patients with severe symptoms and uncontrollable angina;
- Pregnant women, lactating women or women of childbearing age who have birth requirements;
- Mental patients, or cognitive dysfunction;
- The investigator believes that there are other situations that are not suitable for the trial.
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. | Drug | Exposed group |
Primary outcome
Symptoms of angina
Time frame: one year
Dosage and frequency of use of nitroglycerin
Time frame: one year
Clinical biochemical indicators test
Time frame: one year
Film degree exam
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2019.
- Derived from this study: PubMed 37550157Lai Z, Liu Y, Huang M, Li L, Li Z, Su J, Pan G, Li B, Gao S, Yu C. Associations Between Atherosclerosis and Elevated Serum Alkaline Phosphatase in Patients With Coronary Artery Disease in an Inflammatory State. Heart Lung Circ. 2023 Sep;32(9):1096-1106. doi: 10.1016/j.hlc.2023.05.012. Epub 2023 Aug 5.
- Derived from this study: PubMed 36114495Wang J, Huang X, Fu C, Sheng Q, Liu P. Association between triglyceride glucose index, coronary artery calcification and multivessel coronary disease in Chinese patients with acute coronary syndrome. Cardiovasc Diabetol. 2022 Sep 16;21(1):187. doi: 10.1186/s12933-022-01615-4.
- Derived from this study: PubMed 35784545Yu L, Li Z, Yang R, Pan G, Cheng Q, He Y, Liu Y, Liu F, Ma M, Yang T, Wang Y, Su J, Zheng Y, Gao S, Xu Q, Li L, Yu C. Impaired Sensitivity to Thyroid Hormones Is Associated With Elevated Blood Glucose in Coronary Heart Disease. Front Endocrinol (Lausanne). 2022 Jun 15;13:895843. doi: 10.3389/fendo.2022.895843. eCollection 2022.
- Derived from this study: PubMed 35668496Su J, Li Z, Huang M, Wang Y, Yang T, Ma M, Ni T, Pan G, Lai Z, Li C, Li L, Yu C. Triglyceride glucose index for the detection of the severity of coronary artery disease in different glucose metabolic states in patients with coronary heart disease: a RCSCD-TCM study in China. Cardiovasc Diabetol. 2022 Jun 6;21(1):96. doi: 10.1186/s12933-022-01523-7.
- 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. This study is not recruiting at the moment.
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 Atherosclerotic Heart Disease With Angina Nos, 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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 22 Jul 2019. 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?
Results are not available in the source record.
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?
Symptoms of angina (time frame: one year). The study lists 4 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 NCT04026724, which also lists 4 linked publications.
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 22 Jul 2019.