Diagnostic Performance of Fractional Flow Reserve Derived From Coronary CT Angiography

Study Overview
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Brief Summary
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This is a blind evaluation, self-control, multicenter clinical trial designed to determine the diagnostic performance of CT-FFR from coronary computed tomographic angiography (CCTA), as compared to CCTA alone, for non-invasive diagnosis of the presence of a hemodynamically significant coronary stenosis, using invasive fractional flow reserve (FFR) as the reference standard.

Official Title
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Coronary CT Angiography-Derived Fractional Flow Reserve for Functional Evaluation of Coronary Artery Disease

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Diagnostic Test: FFR


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age≥ 18 years old; Subjects with clinical need and consent for coronary angiography; Can provide the results of coronary CT angiography within 60 days prior to ICA or agree to undergo coronary CT angiography; The subjects knew about the experiment and signed the informed consent voluntarily. Exclusion Criteria: Patients who have had percutaneous coronary intervention (PCI); Patients who had CABG; Acute coronary syndrome, such as acute ST segment elevation; Severe tachycardia or arrhythmia; Patients with severe hepatorenal insufficiency; Patients with congenital heart disease, implanted pacemaker or defibrillator, artificial heart valve; Failure to perform invasive FFR examination or obtain FFR value due to various reasons; Allergic to β - blockers, nitrates and adenosine, sick sinus syndrome, long QT syndrome, severe hypotension, severe asthma, severe COPD or COPD; Persistent or significant clinical instability, including acute chest pain (sudden onset), cardiogenic shock, blood pressure instability (systolic blood pressure < 90mmHg) and severe congestive heart failure (according to the heart classification of the New York Heart Association, grade III or IV of cardiac function) or acute pulmonary edema; The CTA images of coronary artery showed that the stenosis rate was less than 30% or greater than 90%, or the diameter of diseased segment was less than 2.0mm; CT-FFR can not be calculated because of the quality of CTA image; Known pregnant and lactating women; Having participated in other clinical trials within 3 months; Other situations that the researchers judged were not suitable for inclusion.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: FFR|FFR measured by pressure wire, CT-FFR computed by coronary CT angiography|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity of CT-FFR compared to FFR |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy and AUC of CT-FFR compared to FFR |  | 1 day |