Development of CV Risk Prediction Tools Based on AI and Fundus Imaging Technology Study (PERFECT) (PERFECT)

December 20, 2023 updated by: China National Center for Cardiovascular Diseases

Development of Cardiovascular Risk Prediction Tools Based on Artificial Intelligence and Fundus Imaging Technology Study

This study aims to develop a cardiovascular disease (CVD) screening tool and cardiovascular risk prediction tool based on fundus imaging data with the method of artificial intelligence.

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

This study will establish a cohort of individuals including patients with CVD and participants with high CVD risk, and all the study participants will be follow-up for 1 year. By collecting baseline clinical data, fundus imaging data, and CVD events during the follow up, this study aims to distinguish CVD status based on the fundus imaging data, and explore the association between fundus imaging data and occurence of CVD during the follow up. By using machine learning approach, this study aims to construct a CVD screening tool and CVD prediction tool based on fundus imaging data.

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.
1072

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

Yes

Sampling Method

Non-Probability Sample

Study Population

Participants with CVD, or otherwise with high CVD risk will be enrolled.

Description

Inclusion Criteria:

Three types of participants will be included, which are:

  • Participants with established coronary heart disease, including previously diagnosed myocardial infarction, previous treatment with coronary intervention or coronary artery bypass grafting, coronary artery stenosis ≥50%, or chest pain with objective evidence of myocardial ischemia (myocardial ischemia indicated by stress electrocardiogram or stress imaging)
  • Participants with established stroke.

  • Participants without coronary heart disease or stroke, but are at high risk for CVD, defined as meeting at least two of the following:

    1. Men aged ≥ 60 years old, or women aged ≥ 65 years old;
    2. Diabetes;
    3. Total cholesterol>5.2 mmol/L, or LDL-C>3.4 mmol/L, or HDL-C<1.0 mmol/L;
    4. Currently smoking, defined as daily smoking lasting for 1 year or more.

Exclusion Criteria:

  • Participants unable to provide fundus imaging data required for the study due to the following reasons:

    1. Permanent blindness, blurred vision, flying mosquito disease, or refractive medium opacity seriously affecting fundus examination, such as severe cataracts, vitreous hemorrhage, etc.
    2. Macular edema, severe nonproliferative retinopathy in diabetes, proliferative vitreoretinopathy, radiation ophthalmopathy or retinal vein occlusion
    3. Eyeball enucleation, eye deformities, etc.
    4. Previous retinal laser therapy, injection therapy for any eye, or history of retinal surgery
    5. Photosensitivity, or taking medication that can cause photosensitivity, or currently undergoing photodynamic therapy
    6. Unable to cooperate with examination for collection of fundus imaging data
    7. Other situations that the participants fail to provide fundus imaging data required for the study
  • Suffering from other serious diseases with an expected survival period of less than one year, such as advanced malignant tumors
  • Unable to adhere to follow-up
  • Other conditions which the researchers consider inappropriate for participants to enroll in the study

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.
Participants with CVD

Meeting any of the following:

  1. Established coronary heart disease, including previously diagnosed myocardial infarction, previous treatment with coronary intervention or coronary artery bypass grafting, coronary artery stenosis ≥50%, or chest pain with objective evidence of myocardial ischemia (indicated by stress electrocardiogram or stress imaging)
  2. Stroke
Diagnostic test: fundus photograpgy
All the participants will undergo fundus photography.
Diagnostic test: optical coherence tomography
All the participants will undergo OCT examination.
Other Names:
  • OCT
Diagnostic test: optical coherence tomography angiography
All the participants will undergo OCT-A examination.
Other Names:
  • OCT-A
Participants with high CVD risk

Participants without CVD, but meeting at least two of the following:

  1. Men aged ≥ 60 years old, or women aged ≥ 65 years old;
  2. Diabetes;
  3. Total cholesterol>5.2 mmol/L, or LDL-C>3.4 mmol/L, or HDL-C<1.0 mmol/L;
  4. Currently smoking, defined as daily smoking lasting for 1 year or more.
Diagnostic test: fundus photograpgy
All the participants will undergo fundus photography.
Diagnostic test: optical coherence tomography
All the participants will undergo OCT examination.
Other Names:
  • OCT
Diagnostic test: optical coherence tomography angiography
All the participants will undergo OCT-A examination.
Other Names:
  • OCT-A

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
Diagnosis of ASCVD at baseline
Time Frame: At enrollment
Whether participants have established ASCVD at baseline
At enrollment
Major cardiovascular events
Time Frame: during the 1 year follow-up
a composite of myocardial infarction, coronary or non coronary revascularization surgery, hospitalization or emergency treatment due to new-onset or worsening heart failure, stroke or cardiovascular death
during the 1 year follow-up

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.
China National Center for Cardiovascular Diseases

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.
Beijing Tongren Hospital

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: Jing Li, PhD, MD, National Center for Cardiovascular Diseases, Fuwai Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
December 1, 2023

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.
March 1, 2025

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.
June 1, 2025

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).
November 9, 2023

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.
December 20, 2023

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.
December 26, 2023

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.
December 26, 2023

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.
December 20, 2023

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.
December 1, 2023

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.
  • 2023-GSP-GG-10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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