The Sensitivity and Specificity of CardioSimFFRct Analysis Software on Coronary Artery Stenosis
NCT ID: NCT04569669
Last Updated: 2020-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
325 participants
INTERVENTIONAL
2020-10-09
2022-03-09
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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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.
FFR and FFRCT
All the patients will undergo computed coronary tomography angiography to analysis FFRCT . Then FFR will be measured during invasive cardiac catheterization.
Interventions
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FFR and FFRCT
All the patients will undergo computed coronary tomography angiography to analysis FFRCT . Then FFR will be measured during invasive cardiac catheterization.
Eligibility Criteria
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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.
* 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
* 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);
* 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)
18 Years
80 Years
ALL
No
Sponsors
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Shengshi Technology, Co., Ltd, Hangzhou, China
UNKNOWN
CCRF Inc., Beijing, China
INDUSTRY
Responsible Party
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Principal Investigators
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Yaling Han, professor
Role: PRINCIPAL_INVESTIGATOR
The General Hospital of Northern Theater Command
Locations
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The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Wuhan Asia Heart Hospital
Wuhan, Hubei, China
Nanjing First Hospital
Nanjing, Jiangsu, China
The Second Hospital of Jilin University
Changchun, Jilin, China
The Second Hospital of Dalian University
Dalian, Liaoning, China
General Hospital of Northern Theater Command
Shenyang, Liaoning, China
Tianjin Chest Hospital
Tianjing, Tianjing, China
The First Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Chunguang Qiu, professor
Role: primary
Xi Su, professor
Role: primary
Shaoliang Chen, professor
Role: primary
Bin Liu, professor
Role: primary
Peng Qu, professor
Role: primary
Yaling Han, professor
Role: primary
Hongliang Cong, professor
Role: primary
Jianhua Zhu, professor
Role: primary
Other Identifiers
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SS-YF-101-LCF01-Z
Identifier Type: -
Identifier Source: org_study_id