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

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

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.

Study Overview

• Status: Unknown
• Conditions: Atherosclerotic Heart Disease With Angina Nos

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.

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China, 300193
      • Tianjin University of Traditional Chinese Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Tianjin University of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 1, 2020
• Primary Completion (ANTICIPATED): March 1, 2021
• Study Completion (ANTICIPATED): September 1, 2021

Study Registration Dates

• First Submitted: June 17, 2020
• First Submitted That Met QC Criteria: June 21, 2020
• First Posted (ACTUAL): June 23, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 23, 2020
• Last Update Submitted That Met QC Criteria: June 21, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Metabolic Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pain; Neurologic Manifestations; Coronary Disease; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Chest Pain; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Hypertension; Hypercholesterolemia; Angina Pectoris; Coronary Stenosis
• Other Study ID Numbers: 2020TJUTCM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No