The Sensitivity and Specificity of CardioSimFFRct Analysis Software on Coronary Artery Stenosis

September 29, 2020 updated by: CCRF Inc., Beijing, China

A Clinical Trial on the Diagnostic Performance Based on CT-Derived Fractional Flow Reserve Score Analysis Software for Coronary Artery Stenosis

The device involved in this trail is a diagnostic software with a Prospective, Multicenter, Self Controlled design. FFRCT diagnostic performance was calculated by CardioSimFFRct Analysis software, and the diagnostic accuracy, sensitivity, specificity, positive predictive value and negative predictive performance of FFRCT for myocardial ischemia were calculated per-patient level and per-vessel level with invasive FFR value as gold standard.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

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

The present study is a single arm, open label, prospective trial. Measurement of FFR during invasive cardiac catheterization represents the "gold standard" for assessment of the hemodynamic significance of coronary artery lesions. As we know, the major disadvantage of FFR is that it has to be measured invasively. CardioSimFFRct Analysis software is a non-invasive method to determine FFR which computes the hemodynamic significance of Coronary Artery Disease (FFRCT) from coronary computed tomography angiography（CCTA）data of the subject by using computational fluid dynamics.The FFR derived from FFR-CT will be compared with invasive FFR as gold standard.Moreover CardioSimFFRct also simplifies the coronary artery into a one-dimensional piping model, omits grid engineering, and greatly reduces the complexity of pretreatment.Based on the pressure loss along the pipe flow and the local pressure loss, a fast method for FFR calculation in engineering is proposed. The calculation time can be reduced to several minutes.

FFRct from CardioSimFFRct Analysis software is mainly based on CCTA images to image the coronary arteries. Through three-dimensional reconstruction of the coronary arteries and computational fluid Dynamics (CFD) technology, the simulation of blood flow in the blood vessels is realized to extract the coronary blood flow reserve score (FFR).FFRct has the following characteristics such as the FFR value can be measured noninvasively, without additional damage to patients, avoiding the risks brought by invasive surgery, and the side effects brought by drugs during invasive surgery.FFRct can realize the examination quickly, save the time of doctors' coronary functional assessment, and simplify the process of coronary functional assessment.It also has the function of three-dimensional reconstruction of blood vessels, which makes it convenient for users to view the whole structure of coronary arteries and make artificial correction.The results of FFRct have high repeatability and are easy for users to evaluate.

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.
Interventional

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.
325

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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.
  • Name: Yaling Han, professor
  • Phone Number: +86-024-28851120
  • Email: hanyaling@263.net

Study Locations

  • China
    • Henan
      • Zhengzhou, Henan, China
        • The First Affiliated Hospital of Zhengzhou University
    • Hubei
      • Wuhan, Hubei, China
        • Wuhan Asia Heart Hospital
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Nanjing First Hospital
    • Jilin
      • Changchun, Jilin, China
        • The Second Hospital of Jilin University
    • Liaoning
      • Dalian, Liaoning, China
        • The Second Hospital of Dalian University
      • Shenyang, Liaoning, China
        • General Hospital of Northern Theater Command
    • Tianjing
      • Tianjing, Tianjing, China
        • Tianjin Chest Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • The First Affiliated Hospital Zhejiang University School of Medicine

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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Subjects that participate in this study must fulfill all the following criteria:

General inclusion criteria:

  • Age ≥18 years and ≤ 80 years;
  • Subject providing written informed consent;
  • After the researcher assessed the suspected presence of coronary artery stenosis, coronary angiography and CCTA examination were proposed.

Angiographic inclusion criteria:

  • CCTA inspection should be performed on instruments with at least 64 multidetector rows;
  • CCTA images are clear and readable;
  • The diameter of coronary artery lesion stenosis was measured by CCTA image with 30%-90%;
  • The reference vessel diameter of coronary stenosis was ≥2.5mm by CCTA imaging.

Exclusion Criteria:

If subjects fulfill any of below criteria, this subject shall be exclude from this study.

General exclusion criteria:

  • Pregnant and breast-feeding women;
  • Previous ST-segment elevation myocardial infarction 30 days before CCTA examination, and a history of non-ST-segment elevation myocardial infarction 7 days before CCTA examination;
  • Prior Coronary Artery Bypass Graft（CABG）,Pacemaker, Implantable Cardioverter Defibrillator（ICD）, Artificial Valve Implantation;
  • Hypertrophic obstructive cardiomyopathy;
  • Heart failure(NYHA≥III or Left Ventricular Ejection Fraction（LVEF）< 40%);
  • Atrial fibrillation, supraventricular tachycardia, ventricular tachycardia and other arrhythmias;
  • Body mass index >35kg/m2;
  • Serum creatinine >178µmol/L or 2mg/dl;
  • Allergies or contraindications to contrast agents are known;
  • Subject who received Nicorandil within 2 weeks prior to invasive FFR examination;
  • Any other conditions that are not suitable for the study.

Angiographic exclusion criteria:

  • The quality of CT imaging is not good enough to extract coronary blood vessel trees;
  • Visual measurement of coronary lesion diameter stenosis > 90% by CCTA imaging;
  • The target lesions were diffuse lesions, and the lesion length was ≥ 30mm (visual measurement);
  • There were ≥ 2 stenosis lesions in the target vessel;
  • Stent implantation in the target vessel;
  • Lesions involving aneurysms or myocardial Bridges;
  • The target vessel is very tortuous and it is difficult to predict the passage of the pressure guide wire.
  • Left main disease;
  • Patients with acute coronary syndrome after CCTA examination and before invasive FFR examination;
  • Severe calcification(i.e Diffuse calcification ,Local or segmental calcification)

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

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
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.
Experimental: Patients diagnosed with Coronary Artery Disease（CAD）by CCTA
Patients admitted to hospital with the diagnosed of CAD by CCTA and who accept to participate to the study will undergo the invasive coronary angiography, fractional flow reserve (FFR) will be measured during the invasive coronary angiography.Outcome measures were comparing FFRct to FFR.
Diagnostic test: FFR and FFRCT
All the patients will undergo computed coronary tomography angiography to analysis FFRCT . Then FFR will be measured during invasive cardiac catheterization.

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
Sensitivity and specificity (subject level) of FFRCT
Time Frame: Measurement at Procedure/Baseline Visit
Sensitivity and specificity (subject level) for predicting the functional significance of coronary artery stenosis using CT-Derived Fractional Flow Reserve Score Analysis Software.
Measurement at Procedure/Baseline Visit

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
Measure Description
Time Frame
AUC between FFRCT vs. FFR
Time Frame: Measurement at Procedure/Baseline Visit
Comparing the Area Under Curve(AUC) between FFRct and CCTA to determine the Functional significance of coronary stenosis.
Measurement at Procedure/Baseline Visit
Sensitivity and Specificity between FFRCT vs. FFR
Time Frame: Measurement at Procedure/Baseline Visit
Comparing the Sensitivity and Specificity which at the lesion level between FFRct and CCTA
Measurement at Procedure/Baseline Visit
Accuracy (lesion level and subject level) between FFRCT vs. FFR
Time Frame: Measurement at Procedure/Baseline Visit
Comparing the Accuracy which at the lesion level and subject level between FFRct and CCTA
Measurement at Procedure/Baseline Visit
Positive Predictive Value (PPV) between FFRCT vs. FFR
Time Frame: Measurement at Procedure/Baseline Visit
Comparing the positive predictive value (PPV) between FFRct and CCTA
Measurement at Procedure/Baseline Visit
Negative Predictive Value (NPV) between FFRCT vs. FFR
Time Frame: Measurement at Procedure/Baseline Visit
Comparing the negative predictive value (NPV) between FFRct and CCTA
Measurement at Procedure/Baseline Visit

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.
CCRF Inc., Beijing, China

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.
Shengshi Technology, Co., Ltd, Hangzhou, China

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: Yaling Han, professor, The General Hospital of Northern Theater Command

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 (Anticipated)

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.
October 9, 2020

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.
October 9, 2021

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.
March 9, 2022

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).
July 30, 2020

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.
September 29, 2020

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.
September 30, 2020

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 30, 2020

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 29, 2020

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, 2020

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.
  • SS-YF-101-LCF01-Z

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

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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