Evaluation and Treatment Strategy Development of Coronary Heart Disease Guided by OCT Based on Multimodal Deep Learning

August 5, 2024 updated by: Xiang Ma

Evaluation and Treatment Strategy Development of Coronary Heart Disease Guided by Optical Coherence Tomography Based on Multimodal Deep Learning

This is a retrospective, multicenter, observational study aimed at assessing stent apposition for coronary stent implantation by an optical coherence tomography system constructed by deep learning algorithms and evaluating the prognosis of patients after stent implantation in conjunction with multimodal diagnostic and therapeutic information.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet 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

In this study, we planned to retrospectively collect 2,000 subjects who underwent optical coherence tomography-guided percutaneous coronary stent implantation with an optical coherence tomography system constructed by a deep learning algorithm from 3 centers to assess stent apposition for coronary stent implantation, and to classify subjects into a group with poor stent apposition (axial distance >400 μm or length >1 mm) and a group with good stent apposition. All subjects were followed up within 12 months after the procedure.

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 (Estimated)

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.
2000

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Retrospective data were collected from the First Affiliated Hospital of Xinjiang Medical University and Jining, Shandong Province from 2015 to 2022 Coronary artery disease patients undergoing coronary angiography and OCT examination in the First People's Hospital of China and Xigu District People's Hospital of Gansu Province.

Description

Inclusion Criteria:

  • Age ≥20 years old;
  • Angiography was performed, and OCT imaging of criminal blood vessels was performed before intervention;
  • Type of coronary heart disease: Unstable angina pectoris (UA), ST elevation myocardial infarction (STEMI) And non-ST elevation myocardial infarction (NSTEMI);

Exclusion Criteria:

  • Lack of medical records;
  • Failure to complete follow-up;
  • Previous coronary artery bypass grafting;
  • Severe liver or kidney insufficiency;
  • Infectious diseases, malignancies and bleeding diseases;
  • OCT image quality was caused by large thrombus volume or residual blood in lumen and percutaneous coronary angiography Poor and further excluded.

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.
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 Stent Malapposition
Measurement results of deep learning-based OCT system: Coronary Stent Malapposition
Procedure: Coronary stenting with planned drug eluting stent (DES).
Stenting will be performed with OCT guidance according to the algorithm described in the protocol. A deep learning-based OCT system was used to measure the adherence of coronary stents.
Coronary Stent Well Apposed
Measurement results of a deep learning-based OCT system: Coronary Stent Well Apposed
Procedure: Coronary stenting with planned drug eluting stent (DES).
Stenting will be performed with OCT guidance according to the algorithm described in the protocol. A deep learning-based OCT system was used to measure the adherence of coronary stents.

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
MACE
Time Frame: Post-procedure within 1 year
Patients were followed up within 1 year after OCT and PCI. The follow-up included major adverse cardiac events: All causes were death, recurrent myocardial infarction, target vessel reconstruction, and stent thrombosis.
Post-procedure within 1 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.
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

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Pengfei Liu, M.D, First Affiliated Hospital of Xinjiang Medical University
  • Principal Investigator: Xinliang Peng, M.D, First Affiliated Hospital of Xinjiang Medical University
  • Principal Investigator: Abudusalamu Tuerdimaimaiti, M.D, First Affiliated Hospital of Xinjiang Medical 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 (Estimated)

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 20, 2024

Primary Completion (Estimated)

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, 2026

Study Completion (Estimated)

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, 2026

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 5, 2024

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 5, 2024

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 9, 2024

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.
August 9, 2024

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.
August 5, 2024

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.
August 1, 2024

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.
  • 2022B03022-3

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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