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

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: Unknown
• Conditions: Coronary Stenosis
• Intervention / Treatment: Diagnostic test: FFR and FFRCT

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: Interventional
• Enrollment (Anticipated): 325
• Phase: Not Applicable

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Sensitivity and specificity (subject level) of FFRCT	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

Outcome Measure	Measure Description	Time Frame
AUC between FFRCT vs. FFR	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	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	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	Comparing the positive predictive value (PPV) between FFRct and CCTA	Measurement at Procedure/Baseline Visit
Negative Predictive Value (NPV) between FFRCT vs. FFR	Comparing the negative predictive value (NPV) between FFRct and CCTA	Measurement at Procedure/Baseline Visit

Collaborators and Investigators

• Sponsor: CCRF Inc., Beijing, China
• Collaborators: Shengshi Technology, Co., Ltd, Hangzhou, China
• Investigators: Principal Investigator: Yaling Han, professor, The General Hospital of Northern Theater Command

Study record dates

Study Major Dates

• Study Start (Anticipated): October 9, 2020
• Primary Completion (Anticipated): October 9, 2021
• Study Completion (Anticipated): March 9, 2022

Study Registration Dates

• First Submitted: July 30, 2020
• First Submitted That Met QC Criteria: September 29, 2020
• First Posted (Actual): September 30, 2020

Study Record Updates

• Last Update Posted (Actual): September 30, 2020
• Last Update Submitted That Met QC Criteria: September 29, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pathological Conditions, Anatomical; Coronary Disease; Constriction, Pathologic; Coronary Stenosis
• Other Study ID 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