Effect of Hypercholesterolemia With or Without Hypertension on Coronary Artery Stenosis in Patients With Angina: a Retrospective Study

Atherosclerotic Heart Disease With Angina Nos Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04444024
• Other study ID #: 2020TJUTCM
• Status: Not yet recruiting
• Start date: September 1, 2020
• Est. completion date: September 1, 2021

Study information

• Verified date: June 2020
• Source: Tianjin University of Traditional Chinese Medicine
• Contact: Chunquan Yu, Dr.
• Phone: 8622-59596309
• Email: ycq-4[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: September 1, 2021
• Est. primary completion date: March 1, 2021
• Gender: All
• Age group: 35 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Angina Pectoris
• Atherosclerotic Heart Disease With Angina Nos
• Coronary Artery Disease
• Coronary Stenosis
• Heart Diseases
• Hypercholesterolemia
• Hypertension
• Myocardial Ischemia

Locations

Country	Name	City	State
China	Tianjin University of Traditional Chinese Medicine	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fasting blood glucose in clinical biochemical tests.	In the hospital medical record management system, the investigators collect the fasting blood glucose data of the first day of hospitalization of the patients.	one year
Primary	Glycated hemoglobin in clinical biochemical tests.	In the hospital medical record management system, the investigators collect the glycated hemoglobin data of the first day of hospitalization of the patients.	one year
Primary	Total cholesterol in clinical biochemical tests.	In the hospital medical record management system, the investigators collect the total cholesterol data of the first day of hospitalization of the patients.	one year
Primary	Triglyceride in clinical biochemical tests.	In the hospital medical record management system, the investigators collect the triglyceride data of the first day of hospitalization of the patients.	one year
Primary	Low density lipoprotein cholesterol in clinical biochemical tests.	In the hospital medical record management system, the investigators collect the low density lipoprotein cholesterol data of the first day of hospitalization of the patients.	one year
Primary	High density lipoprotein cholesterol in clinical biochemical tests.	In the hospital medical record management system, the investigators collect the high density lipoprotein cholesterol data of the first day of hospitalization of the patients.	one year
Primary	C-reactive protein in clinical biochemical tests.	In the hospital medical record management system, the investigators collect the C-reactive protein data of the first day of hospitalization of the patients.	one year
Primary	Fibrinogen in clinical biochemical tests.	In the hospital medical record management system, the investigators collect the fibrinogen data of the first day of hospitalization of the patients.	one year
Primary	Coronary angiography data in imaging examination.	In the hospital medical record management system, the investigators collect coronary angiography data of the patient's hospitalization.	one year
Primary	Age in demographics.	In the hospital medical record management system, the investigators collect the age data of the first day of hospitalization of the patients.	one year
Primary	Gender in demographics.	In the hospital medical record management system, the investigators collect the gender data of the first day of hospitalization of the patients.	one year
Primary	Ethnicity in demographics.	In the hospital medical record management system, the investigators collect the ethnicity data of the first day of hospitalization of the patients.	one year
Primary	Weight in demographics.	In the hospital medical record management system, the investigators collect the weight data of the first day of hospitalization of the patients.	one year
Primary	Smoking in demographics.	In the hospital medical record management system, the investigators collect the smoking data of the first day of hospitalization of the patients.	one year
Primary	Medical history in demographics.	In the hospital medical record management system, the investigators collect the medical history data of the first day of hospitalization of the patients.	one year
Primary	Blood pressure in demographics.	In the hospital medical record management system, the investigators collect the blood pressure data of the first day of hospitalization of the patients.	one year
Secondary	Evaluate the correlation between total cholesterol level and the degree of coronary artery stenosis	Based on the total cholesterol level, the investigators divide patients into 3 groups. According to the location and degree of the lumen stenosis, the score of the degree of each coronary artery stenosis is calculated.	one year
Secondary	Assess the effect of with or without hypertension on the correlation between total cholesterol level and the degree of coronary artery stenosis	According to with or without hypertension, the patients are further divided into 6 subgroups.	one year