Clinical trial NCT04444024: Effect of Hypercholesterolemia With or Without Hypertension on Coronary Artery Stenosis in Patients With Angina: a Retrospective Study
Official title: Effect of Hypercholesterolemia Alone or Combined With Hypertension on the Degree of Coronary Artery Stenosis in Patients With Coronary Heart Disease Angina Pectoris: a Retrospective Study
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: 2020-06-23
Enrollment: 1000
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The collaborative network of Coronary heart disease research medical units formed by the research team includes 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, the affiliated Hospital of Tianjin Institute of traditional Chinese Medicine, Tianjin chest Hospital and Tianjin Medical University General Hospital.

Brief summary: A multicenter, retrospective clinical study was carried out in the medical records management system of 6 hospitals in Tianjin. Patients who were suffered with Coronary heart disease angina pectoris and underwent coronary angiography are collected. The investigators collect and analyze the demographics, laboratory information, clinical outcome data, and coronary angiographic data of patients. To explore the correlation between hypercholesterolemia and the degree of coronary artery stenosis of Coronary heart disease angina pectoris, and to further research the influence of hypertension on total cholesterol level and coronary artery stenosis, and provide guidance for clinical prevention and treatment.

Detailed description: Based on the total cholesterol level, the investigators divided patients into 3 groups: patients with TC \< 5.18 mmol/l belong to normal TC (NTC) group, 5.18 ≤ TC \< 6.19 mmol/l is borderline-high TC (BHTC) group, those with TC ≥6.19 mmol/l belong to high TC (HTC) group, and the correlation between the TC and the degree of coronary artery stenosis is evaluated. With or without hypertension will be further stratified to assess the effect of with or without hypertension on the correlation between TC levels and the degree of coronary artery stenosis. The 6 subgroups are: NTC/-HTN group, NTC/+HTN group, BHTC/-HTN group, BHTC/+HTN group, HTC/-HTN group, HTC/+HTN group.

The investigators refer to the recent diagnostic guidelines for coronary heart disease angina pectoris at home and abroad. The diagnosis can be given if it meets any one or more of the following:

1. There was a clear history of old myocardial infarction.
2. Previous coronary angiography or coronary CTA examination showed that at least one major branch of coronary artery has a lumen diameter stenosis ≥50%.
3. Those with ST-segment depression or T-wave inversion on ECG after coronary revascularization.

The investigators will redefined hypertension as systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥80 mmHg according to the recently published 2017 ACC/AHA guidelines.

Eligibility criteria: Inclusion Criteria:

1. Patients aged from 35 to 75 years old, male or female.
2. Those who were hospitalized between September 1, 2014 and September 1, 2019.
3. Patients with Coronary heart disease angina pectoris and have undergone coronary angiography in the inpatient department of cardiovascular internal medicine.
4. The diagnosis of hypercholesterolemia, Coronary heart disease angina pectoris and hypertension is accorded with the diagnostic criteria.

Exclusion Criteria:

1. Those with other cardiac diseases, gastroesophageal reflux disease or hiatal hernia, neurosis, spinal or vertebral artery cervical spondylosis, hyperthyroidism, climacteric syndrome, etc.
2. Those with myocarditis, cardiomyopathy, acute myocardial infarction, third degree of heart failure, severe heart valve disease, major diseases such as malignant tumor and serious metabolic diseases, liver failure or renal failure.
3. Those with psychotic disorders, or cognitive dysfunction.
4. Those of childbearing age and have fertility requirements, or pregnant women or lactating women.
5. Those allergic to iodine contrast medium.
6. Those who are not suitable for the study, as judged by the researcher.

Primary outcomes:
measure: Fasting blood glucose in clinical biochemical tests.
timeFrame: one year
measure: Glycated hemoglobin in clinical biochemical tests.
timeFrame: one year
measure: Total cholesterol in clinical biochemical tests.
timeFrame: one year
measure: Triglyceride in clinical biochemical tests.
timeFrame: one year
measure: Low density lipoprotein cholesterol in clinical biochemical tests.
timeFrame: one year
measure: High density lipoprotein cholesterol in clinical biochemical tests.
timeFrame: one year
measure: C-reactive protein in clinical biochemical tests.
timeFrame: one year
measure: Fibrinogen in clinical biochemical tests.
timeFrame: one year
measure: Coronary angiography data in imaging examination.
timeFrame: one year
measure: Age in demographics.
timeFrame: one year
measure: Gender in demographics.
timeFrame: one year
measure: Ethnicity in demographics.
timeFrame: one year
measure: Weight in demographics.
timeFrame: one year
measure: Smoking in demographics.
timeFrame: one year
measure: Medical history in demographics.
timeFrame: one year
measure: Blood pressure in demographics.
timeFrame: one year
Secondary outcomes:
measure: Evaluate the correlation between total cholesterol level and the degree of coronary artery stenosis
timeFrame: one year
measure: Assess the effect of with or without hypertension on the correlation between total cholesterol level and the degree of coronary artery stenosis
timeFrame: one year
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin University of Traditional Chinese Medicine
state: Tianjin
Study officials:
References: