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

June 21, 2020 updated by: Chunquan Yu, Tianjin University of Traditional Chinese Medicine

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Fasting blood glucose in clinical biochemical tests.
Time Frame: one year
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.
Time Frame: one year
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.
Time Frame: one year
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.
Time Frame: one year
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.
Time Frame: one year
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.
Time Frame: one year
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.
Time Frame: one year
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.
Time Frame: one year
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.
Time Frame: one year
In the hospital medical record management system, the investigators collect coronary angiography data of the patient's hospitalization.
one year
Age in demographics.
Time Frame: one year
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.
Time Frame: one year
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.
Time Frame: one year
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.
Time Frame: one year
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.
Time Frame: one year
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.
Time Frame: one year
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.
Time Frame: one year
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Evaluate the correlation between total cholesterol level and the degree of coronary artery stenosis
Time Frame: one year
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
Time Frame: one year
According to with or without hypertension, the patients are further divided into 6 subgroups.
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tianjin University of Traditional Chinese Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2020

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2021

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 17, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 21, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 23, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 23, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 21, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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