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出境医 / 临床实验 / Clinical Study on Adjuvant Treatment of Coronary Heart Disease Angina Pectoris With Chinese Patent Medicine (CSCD-TCM)

Clinical Study on Adjuvant Treatment of Coronary Heart Disease Angina Pectoris With Chinese Patent Medicine (CSCD-TCM)

Study Description
Brief Summary:
A prospective cohort study was performed in patients with angina pectoris who were treated with oral Chinese patent medicine and Western medicine.Collect primary and secondary efficacy indicators such as the incidence of cardiovascular events, 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 coronary heart disease with angina pectoris, and provide reliable data support for its clinical application.

Condition or disease Intervention/treatment
Atherosclerotic Heart Disease With Angina Nos Drug: Chinese patent medicine

Study Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 12400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Cohort Study on Adjuvant Treatment of Coronary Heart Disease Angina Pectoris With Chinese Patent Medicine
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : September 1, 2022
Arms and Interventions
Group/Cohort Intervention/treatment
Exposed group
Chinese patent medicine combined with western medicine routine
 Drug: Chinese patent medicine
Shexiang Baoxin Pill, Tongxinluo Capsule, Tongmai Yangxin Pill, Xuefu Zhuyu Capsule, Qishen Yiqi Dropping Pill.
Non-exposed group
Western medicine routine treatment
Outcome Measures
Primary Outcome Measures :
  1. Incidence of cardiovascular events [ Time Frame: one year ]
    These include acute myocardial infarction (AMI), percutaneous coronary intervention (PCI), or coronary artery bypass grafting (CABG).


Secondary Outcome Measures :
  1. Death from all causes [ Time Frame: one year ]
  2. Re-admission due to cardiovascular events [ Time Frame: one year ]
  3. Seattle Angina Questionnaire [ Time Frame: three months ]
  4. Clinical biochemical test [ Time Frame: three months ]
  5. Film degree exam [ Time Frame: three months ]

Biospecimen Retention:   Samples With DNA
Blood, urine, feces, tongue coating

Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes 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 Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, the Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin Chest Hospital, Tianjin Nankai Hospital, Tianjin Medical University General Hospital，a total of 5 hospitals.
Criteria

Inclusion Criteria:

  1. Voluntarily participate, understand and sign the informed consent form;
  2. Age 35-75 years old, gender is not limited;
  3. 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;
  4. 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.

Exclusion Criteria:

  1. 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;
  2. Patients with severe symptoms and uncontrollable angina pectoris, with acute myocardial infarction, heart failure, myocarditis, cardiomyopathy, severe heart valve disease, liver failure or renal failure, malignant tumors and serious metabolic diseases;
  3. Pregnant women, lactating women or women of childbearing age who have birth requirements;
  4. Mental patients, or cognitive dysfunction;
  5. Participated in other clinical trials in the last 3 months;
  6. Allergic persons, or those known to be allergic to therapeutic drugs;
  7. It is expected that the compliance is poor and it is not possible to visit regularly;
  8. Patients who do not have a current address or whose current address is incomplete and have no contact number;
  9. The investigator believes that there are other situations that are not suitable for the trial.
Contacts and Locations

Locations
Layout table for location information
China, Tianjin
Tianjin University of Traditional Chinese Medicine
Tianjin, Tianjin, China, 300193
Sponsors and Collaborators
Tianjin University of Traditional Chinese Medicine
Tracking Information
First Submitted Date July 13, 2019
First Posted Date July 16, 2019
Last Update Posted Date July 17, 2019
Estimated Study Start Date September 1, 2019
Estimated Primary Completion Date September 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 13, 2019) 		Incidence of cardiovascular events [ Time Frame: one year ]
These include acute myocardial infarction (AMI), percutaneous coronary intervention (PCI), or coronary artery bypass grafting (CABG).
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 16, 2019)
  • Death from all causes [ Time Frame: one year ]
  • Re-admission due to cardiovascular events [ Time Frame: one year ]
  • Seattle Angina Questionnaire [ Time Frame: three months ]
  • Clinical biochemical test [ Time Frame: three months ]
  • Film degree exam [ Time Frame: three months ]
Original Secondary Outcome Measures
 (submitted: July 13, 2019)
  • Death from all causes [ Time Frame: one year ]
  • Re-admission due to cardiovascular events [ Time Frame: one year ]
  • Seattle Angina Scale SAQ [ Time Frame: three months ]
  • Clinical biochemical test [ Time Frame: three months ]
  • Film degree exam [ Time Frame: three months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Clinical Study on Adjuvant Treatment of Coronary Heart Disease Angina Pectoris With Chinese Patent Medicine
Official Title Prospective Cohort Study on Adjuvant Treatment of Coronary Heart Disease Angina Pectoris With Chinese Patent Medicine
Brief Summary A prospective cohort study was performed in patients with angina pectoris who were treated with oral Chinese patent medicine and Western medicine.Collect primary and secondary efficacy indicators such as the incidence of cardiovascular events, 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 coronary heart disease with angina pectoris, and provide reliable data support for its clinical application.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood, urine, feces, tongue coating
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 Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, the Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin Chest Hospital, Tianjin Nankai Hospital, Tianjin Medical University General Hospital，a total of 5 hospitals.
Condition Atherosclerotic Heart Disease With Angina Nos
Intervention Drug: Chinese patent medicine
Shexiang Baoxin Pill, Tongxinluo Capsule, Tongmai Yangxin Pill, Xuefu Zhuyu Capsule, Qishen Yiqi Dropping Pill.
Study Groups/Cohorts
  • Exposed group
    Chinese patent medicine combined with western medicine routine
    Intervention: Drug: Chinese patent medicine
  • Non-exposed group
    Western medicine routine treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: July 13, 2019) 		12400
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 1, 2022
Estimated Primary Completion Date September 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Voluntarily participate, understand and sign the informed consent form;
  2. Age 35-75 years old, gender is not limited;
  3. 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;
  4. 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.

Exclusion Criteria:

  1. 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;
  2. Patients with severe symptoms and uncontrollable angina pectoris, with acute myocardial infarction, heart failure, myocarditis, cardiomyopathy, severe heart valve disease, liver failure or renal failure, malignant tumors and serious metabolic diseases;
  3. Pregnant women, lactating women or women of childbearing age who have birth requirements;
  4. Mental patients, or cognitive dysfunction;
  5. Participated in other clinical trials in the last 3 months;
  6. Allergic persons, or those known to be allergic to therapeutic drugs;
  7. It is expected that the compliance is poor and it is not possible to visit regularly;
  8. Patients who do not have a current address or whose current address is incomplete and have no contact number;
  9. The investigator believes that there are other situations that are not suitable for the trial.
Sex/Gender
Sexes Eligible for Study: All
Ages 35 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT04022031
Other Study ID Numbers CSCD-TCM
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
Responsible Party Chunquan Yu, Tianjin University of Traditional Chinese Medicine
Study Sponsor Tianjin University of Traditional Chinese Medicine
Collaborators Not Provided
Investigators Not Provided
PRS Account Tianjin University of Traditional Chinese Medicine
Verification Date July 2019

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