Clinical trial NCT04026724: Retrospective Clinical Study on Adjuvant Treatment of Coronary Heart Disease Angina Pectoris With Chinese Patent Medicine
Official title: Retrospective 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: 2019-07-19
Enrollment: 12400
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
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 Nankai Hospital, Tianjin Chest Hospital, Tianjin Medical University General Hospital, a total of 5 hospitals.

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

1. Age 35-75 years old, gender is not limited;
2. Admission time is September 1, 2014 - September 1, 1919;
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 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;
3. Pregnant women, lactating women or women of childbearing age who have birth requirements;
4. Mental patients, or cognitive dysfunction;
5. The investigator believes that there are other situations that are not suitable for the trial.

Primary outcomes:
measure: Symptoms of angina
timeFrame: one year
measure: Dosage and frequency of use of nitroglycerin
timeFrame: one year
measure: Clinical biochemical indicators test
timeFrame: one year
measure: Film degree exam
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin University of Traditional Chinese Medicine
state: Tianjin
Study officials:
References:
citation: Wang 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.
citation: Yu 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.
citation: Su 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.