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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

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.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

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.
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

  • China
    • 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

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

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

Group / Cohort

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

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Diagnostic test: Machine learning model diagnosis
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

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
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xiang Ma

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Shihezi University

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)

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.
August 22, 2021

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.
December 31, 2023

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.
December 31, 2023

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).
August 22, 2021

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.
August 22, 2021

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.
August 24, 2021

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.
September 2, 2021

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.
September 1, 2021

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.
September 1, 2021

More Information

Terms related to this study

Keywords

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.
  • 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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