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

NCT04444024 | Unknown

• 1 other identifier: 2020TJUTCM
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Atherosclerotic Heart Disease With Angina Nos

Outcome Measures

Primary Outcomes (16)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (2)

• Evaluate the correlation between total cholesterol level and the degree of coronary artery stenosis

  one year

• Assess the effect of with or without hypertension on the correlation between total cholesterol level and the degree of coronary artery stenosis

  one year

Study Arms (6)

NTC/-HTN group

Patients with TC \< 5.18 mmol/l, systolic blood pressure \<130 mmHg and diastolic blood pressure \<80 mmHg belong to normal TC/ none hypertension(NTC/-HTN) group.

NTC/+HTN group

Patients with TC \< 5.18 mmol/l, systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥80 mmHg belong to normal TC/ hypertension(NTC/+HTN) group.

BHTC/-HTN group

Patients whose TC is 5.18 ≤ TC \< 6.19 mmol/l, systolic blood pressure \<130 mmHg and diastolic blood pressure \<80 mmHg belong to borderline-high TC/ none hypertension (BHTC/-HTN) group.

BHTC/+HTN group

Patients whose TC is 5.18 ≤ TC \< 6.19 mmol/l, systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥80 mmHg belong to borderline-high TC/ hypertension (BHTC/+HTN) group.

HTC/-HTN group

Patients with TC ≥6.19 mmol/l, systolic blood pressure \<130 mmHg and diastolic blood pressure \<80 mmHg belong to high TC/ none hypertension(HTC/-HTN) group.

HTC/+HTN group

Patients with TC ≥6.19 mmol/l, systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥ 80 mmHg belong to high TC/ hypertension(HTC/+HTN) group.

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Those with other cardiac diseases, gastroesophageal reflux disease or hiatal hernia, neurosis, spinal or vertebral artery cervical spondylosis, hyperthyroidism, climacteric syndrome, etc.
• 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.
• Those with psychotic disorders, or cognitive dysfunction.
• Those of childbearing age and have fertility requirements, or pregnant women or lactating women.
• Those allergic to iodine contrast medium.
• Those who are not suitable for the study, as judged by the researcher.

Sponsors & Collaborators

• Tianjin University of Traditional Chinese Medicine: lead

Study Sites (1)

Tianjin University of Traditional Chinese Medicine

Tianjin, Tianjin Municipality, 300193, China

Location

Central Study Contacts

Chunquan Yu, Dr.

CONTACT

8622-59596309; ycq-4@163.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: researcher

Study Record Dates

• First Submitted: June 17, 2020
• First Posted: June 23, 2020
• Study Start: September 1, 2020
• Primary Completion: March 1, 2021
• Study Completion: September 1, 2021
• Last Updated: June 23, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)