- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05018715
Research on the Diagnostic Value of Machine Learning Model Based on Clinical Data in Patients With Coronary Heart Disease
September 1, 2021 updated by: Xiang Ma
Based on the clinical data of patients, a machine learning model for coronary heart disease diagnosis was established to evaluate whether the model could improve the accuracy of coronary heart disease diagnosis, and to evaluate its authenticity, reliability and benefits.
Study Overview
Status
Active, not recruiting
Intervention / Treatment
Detailed Description
A total of 300 patients with CHD WHO were hospitalized in the First Affiliated Hospital of Xinjiang Medical University from August 2021 to February 2022 were selected, all of whom met the DIAGNOSTIC criteria of CHD formulated by the World Health Organization (WHO) and excluded diseases such as highly severe valvular disease and congenital heart disease.A total of 300 healthy subjects from the First Affiliated Hospital of Xinjiang Medical University during the same period were selected as controls.Observation indicators included: Clinical indicators collected included: General conditions: gender, age, medical history;Blood biochemical indexes, such as blood routine, liver function, kidney function, blood lipid, blood glucose, myocardial markers, electrolyte, serum creatinine concentration, body mass index, BNP and other indicators;Related tests such as ELECTROcardiogram, holter electrocardiogram, cardiac ultrasound (left atrial diameter, ascending aorta, ventricular septal thickness, left posterior wall thickness, right ventricular diameter, ejection fraction, abnormal ventricular wall motion, evidence of infarction or ischemia, valve abnormality, congenital heart disease, etc.);Signs include: audio data of heart sounds in nine parts of precardiac area;Medication status.All blood biochemical indexes and examinations were completed in the laboratory department and ultrasound department of our hospital, and the physical signs were completed in the ward.The results of coronary angiography, pre-hospital and post-hospital echocardiography and other related data were recorded.Machine learning model was constructed based on clinical data to assist diagnosis of patients with coronary heart disease
Study Type
Observational
Enrollment (Anticipated)
600
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
-
-
Xinjiang
-
Ürümqi, Xinjiang, China, 830000
- The First Affiliated Hospital of Xinjiang Medical University
-
-
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
Ages Eligible for Study
18 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
CHD patients and healthy subjects who were hospitalized in the First Affiliated Hospital of Xinjiang Medical University from August 2021 to February 2022 were selected
Description
Inclusion Criteria:
- Patients who meet the diagnostic criteria for CHD set by the World Health Organization
Exclusion Criteria:
- Exclude serious valvular disease, congenital heart disease, respiratory system and other diseases.
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
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
coronary heart disease
A total of 300 patients with CHD WHO were hospitalized in the First Affiliated Hospital of Xinjiang Medical University from August 2021 to February 2022 were selected, all of whom met the DIAGNOSTIC criteria of CHD formulated by the World Health Organization (WHO) and excluded diseases such as highly severe valvular disease and congenital heart disease
|
Machine learning model diagnosis
|
|
Healthy person
.A total of 300 healthy subjects from the First Affiliated Hospital of Xinjiang Medical University during the same period were selected as controls.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
make a definite diagnosis of CHD
Time Frame: 2021-2023
|
Based on the patient's typical angina pectoris symptoms, combined with the patient's age and coronary heart disease risk factors, and excluding other causes of angina pectoris, a preliminary diagnosis can be established.
Coronary CTA, coronary angiography and other examinations find direct evidence of coronary artery stenosis, which can confirm the diagnosis
|
2021-2023
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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 (Actual)
August 22, 2021
Primary Completion (Anticipated)
December 31, 2023
Study Completion (Anticipated)
December 31, 2023
Study Registration Dates
First Submitted
August 22, 2021
First Submitted That Met QC Criteria
August 22, 2021
First Posted (Actual)
August 24, 2021
Study Record Updates
Last Update Posted (Actual)
September 2, 2021
Last Update Submitted That Met QC Criteria
September 1, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- XMa0001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
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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