Clinical trial NCT04022031: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atherosclerotic Heart Disease With Angina Nos
Lead sponsor: Tianjin University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2019-07-16
Enrollment: 12400
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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.

Primary outcomes:
measure: Incidence of cardiovascular events
timeFrame: one year
Secondary outcomes:
measure: Death from all causes
timeFrame: one year
measure: Re-admission due to cardiovascular events
timeFrame: one year
measure: Seattle Angina Questionnaire
timeFrame: three months
measure: Clinical biochemical test
timeFrame: three months
measure: Film degree exam
timeFrame: three months
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin University of Traditional Chinese Medicine
state: Tianjin
Study officials:
References: