Atherosclerotic Heart Disease With Angina NosNCT04444024
Effect of Hypercholesterolemia With or Without Hypertension on Coronary Artery Stenosis in Patients With Angina: a Retrospective Study
An observational study of Atherosclerotic Heart Disease With Angina Nos, run by Tianjin University of Traditional Chinese Medicine at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Atherosclerotic Heart Disease With Angina Nos
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2020to 1 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Tianjin University of Traditional Chinese Medicine
Tianjin, Tianjin Municipality, 300193
Chunquan Yu, Dr., 8622-59596309, ycq-4@163.com
About this 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
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.
Read the 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:
- There was a clear history of old myocardial infarction.
- Previous coronary angiography or coronary CTA examination showed that at least one major branch of coronary artery has a lumen diameter stenosis ≥50%.
- 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: one year
Secondary outcomes (2)
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.
Measured: 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.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2020
- Study start1 Sep 2020 (estimated)
- Primary completion1 Mar 2021 (estimated)
- Study completion1 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atherosclerotic Heart Disease With Angina NosStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chunquan Yu, Tianjin University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04444024
- Sponsor's protocol ID
- 2020TJUTCM
- Status last verified
- Jun 2020
- First submitted
- 17 Jun 2020
- Last updated
- 23 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04444024
- Acronym / sponsor ID
- 2020TJUTCM
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Tianjin University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 1 Mar 2021 (estimated)
- Study completion
- 1 Sep 2021 (estimated)
- First posted
- 23 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- There was a clear history of old myocardial infarction.
- Previous coronary angiography or coronary CTA examination showed that at least one major branch of coronary artery has a lumen diameter stenosis ≥50%.
- 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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
2 secondary outcomes
Evaluate the correlation between total cholesterol level and the degree of coronary artery stenosis
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2020.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atherosclerotic Heart Disease With Angina Nos, run by Tianjin University of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chunquan Yu, Dr. (8622-59596309, ycq-4@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting blood glucose in clinical biochemical tests. (time frame: one year). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2020.