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

NCT04569669 | Unknown DMC

• 1 other identifier: SS-YF-101-LCF01-Z
• Study Type: interventional
• Target: 325
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Coronary Stenosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• AUC between FFRCT vs. FFR

  Measurement at Procedure/Baseline Visit

• Sensitivity and Specificity between FFRCT vs. FFR

  Measurement at Procedure/Baseline Visit

• Accuracy (lesion level and subject level) between FFRCT vs. FFR

  Measurement at Procedure/Baseline Visit

• Positive Predictive Value (PPV) between FFRCT vs. FFR

  Measurement at Procedure/Baseline Visit

• Negative Predictive Value (NPV) between FFRCT vs. FFR

  Measurement at Procedure/Baseline Visit

Study Arms (1)

Patients diagnosed with Coronary Artery Disease（CAD）by CCTA

EXPERIMENTAL

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

Interventions

FFR and FFRCT DIAGNOSTIC_TEST

All the patients will undergo computed coronary tomography angiography to analysis FFRCT . Then FFR will be measured during invasive cardiac catheterization.

Patients diagnosed with Coronary Artery Disease（CAD）by CCTA

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects that participate in this study must fulfill all the following 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.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• CCRF Inc., Beijing, China: lead
• Shengshi Technology, Co., Ltd, Hangzhou, China: collaborator

Study Sites (8)

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Location

Wuhan Asia Heart Hospital

Wuhan, Hubei, China

Location

Nanjing First Hospital

Nanjing, Jiangsu, China

Location

The Second Hospital of Jilin University

Changchun, Jilin, China

Location

The Second Hospital of Dalian University

Dalian, Liaoning, China

Location

General Hospital of Northern Theater Command

Shenyang, Liaoning, China

Location

Tianjin Chest Hospital

Tianjing, Tianjing, China

Location

The First Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Coronary Stenosis

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Yaling Han, professor

  The General Hospital of Northern Theater Command

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yaling Han, professor

CONTACT

+86-024-28851120; hanyaling@263.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2020
• First Posted: September 30, 2020
• Study Start: October 9, 2020
• Primary Completion: October 9, 2021
• Study Completion: March 9, 2022
• Last Updated: September 30, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (8)