CT-FFR for Coronary In-stent Stenosis Based on ISR-Net Algorithm

February 6, 2023 updated by: Xue Yu, Beijing Hospital

Application of New Algorithm ISR-Net in Measuring CT-FFR of Coronary In-stent Stenosis.

CT-FFR(CT-derived flow reserve fraction) usually could not been measured accurately for in-stent lesions due to the serious interference with the metal structs. ISR-Net is a new algorithm in assessing the flow of coronary in-stent stenosis. We compare the CT-FFR value of in-stent lesions with the invasive FFR measured by pressure wire to evaluate the accuracy of ISR-Net algorithm. The research results are of great significance to solve the bottleneck problem of CT-FFR and expand its application scope.

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

CT-FFR is an important noninvasive examination to evaluate the function of coronary artery disease. It can help clinicians make clinical decisions and reduce patients' invasive coronary angiography (ICA). The image quality of coronary CT angiography (CCTA) is the basis of CT-FFR measurement. Because metal stents seriously interfere with the imaging of CCTA, it is very difficult to measure the CT-FFR value of lesions in stents. However, a large number of patients need imaging follow-up evaluation after stenting. In the previous research, the investigators creatively invented a new algorithm ISR-Net and conducted a retrospective analysis. It is preliminarily proved that the algorithm can more accurately display the stenosis lesions in the stent than the previous imaging software, making it possible to calculate the CT-FFR of the lesions in the stent. At present, the algorithm has applied for a national invention patent. In order to transform to clinical application, further clinical verification is needed. This study will evaluate the accuracy of ISR-Net algorithm in assessing the function of coronary stent stenosis by carrying out prospective clinical trials and taking the blood flow reserve fraction (FFR) measured by pressure wire as the gold standard. At the same time, the standard process of CT-FFR measurement of in stent lesions was established. The research results are of great significance to solve the bottleneck problem of CT-FFR and expand its application scope.

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.
150

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
      • Beijing, China
        • Beijing Hospital

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 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients were implanted metal stents previously and had indications for coronary CTA test. The CT-FFR for in-stent lesions were evaluated based on Coronary CTA. Patients had the indication for invasive coronary angiography would be admitted in Cath lab and perform FFR measurement with pressure wire .

Description

Inclusion Criteria:

General Inclusion Criteria:

  • Over 18 years old;
  • Be able to understand the purpose of the test and sign the informed consent form;
  • Previous intracoronary stent implantation;
  • According to the comprehensive clinical evaluation, coronary angiography and FFR were proposed;

CTA image Inclusion Criteria:

  • The coronary CT angiography images showed that the reference vessel diameter of the stenosis segment in the stent was ≥ 2mm;
  • The stenosis degree of coronary stent diameter ≥ 30% and ≤ 90% by visual inspection.

Exclusion Criteria:

General exclusion criteria:

  • Previous coronary artery bypass grafting (CABG), artificial heart valve implantation, pacemaker or implantable defibrillator implantation;
  • There are persistent or active symptoms of clinical instability, including acute chest pain (sudden onset), cardiogenic shock, unstable blood pressure state (systolic blood pressure less than 90 mmHg), severe congestive heart failure (NYHA cardiac function grade III or IV) or acute pulmonary edema;
  • Acute myocardial infarction occurred within 7 days before enrollment;
  • Patients with other severe diseases are not suitable for clinical trials, such as complex congenital heart history, sick sinus syndrome, long QT syndrome, severe arrhythmia or tachycardia, severe asthma, severe or very severe chronic obstructive pulmonary disease, chronic renal function impairment (serum creatinine value > 1.5 mg / dL or creatinine clearance rate < 45ml / kg · 1.73m2);
  • There are contraindications to the use of disodium adenosine triphosphate;
  • Allergic to iodized contrast media;
  • Pregnancy or unknown pregnancy status;
  • The expected life is less than 2 months;
  • There are any other factors that the researchers believe are not suitable for inclusion or completion of this study.

CTA image exclusion criteria:

  • The coronary artery image was obviously misplaced;
  • Coronary artery occlusion.

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: Case-Control
  • 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.
patients with coronary metal stents implantation
Diagnostic test: CT-FFR measurement
Patients were scanned with ≥ 64 row CT according to standard operating specifications. The software obtains the coronary CT angiography image file through the data communication interface. Based on the image processing algorithm, the centerline and contour of the target vessel can be extracted, and then the target vessel can be reconstructed to obtain the three-dimensional size information of the vessel; Based on hydrodynamics calculation and analysis, the fractional flow reserve (FFR) of each position of the target vessel is measured.
Other Names:
  • FFRCT
Procedure: invasive FFR
Insert the pressure guide wire into the finger guide tube and push the pressure guide wire until the pressure sensor just comes out of the orifice of guiding catheter; Equalize PD and PA values;Push the pressure guide wire to the distal end of the lesion, and record the measured blood vessel and position;Record the resting Pd / PA of the pressure guide wire;Nitroglycerin and adenosine triphosphate were administered intravenously according to standard catheter laboratory specifications to achieve maximum hyperemia;Record the FFR value of the in-stent lesions.
Other Names:
  • pressure wire

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
Time Frame
To predict the sensitivity, specificity and accuracy of CT-FFR in the functional sense of in stent lesions based on ISR-Net algorithm.
Time Frame: one month
one month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
To predict the functional accuracy of in stent lesions, PPV, NPV and area under ROC curve (AUC)
Time Frame: one month
one month

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.
Beijing 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 (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.
January 1, 2022

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.
January 1, 2024

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.
June 1, 2024

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 11, 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.
November 11, 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.
November 23, 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.
February 8, 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.
February 6, 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.
February 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.
  • CT-FFR for in-stent lesion

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.

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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