Angiography-Derived Quantitative Functional Assessment Versus Pressure-Derived FFR and IMR: The FAIR Study

Study Overview
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Brief Summary
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Coronary angiography-derived FFR assessment (AngioQFA) is a novel technique for physiological lesion assessment based on 3-dimensional (3D) quantitative coronary angiography (QCA) and virtual hyperemic flow derived from contrast frame count without drug-induced hyperemia. The goal of this prospective, multicenter trial is to compare the diagnostic performance of AngioQFA with invasive FFR as the reference standard. The secondary purpose is to compare the diagnostic accuracies of the computational fluid dynamics (CFD)-based index of microcirculatory resistance (IMR) using wire-based IMR as the reference standard.

Official Title
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Diagnostic Performance of Angiography-Derived Quantitative Functional Assessment Compared to Pressure-Derived Fractional Flow Reserve and Index of Microcirculatory Resistance: The FAIR Study

Conditions
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Coronary Artery Disease, Heart Diseases, Cardiovascular Diseases, Arteriosclerosis, Coronary Stenosis, Vascular Diseases, Ischemia

Intervention / Treatment
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* Other: AngioQFA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria General Inclusion Criteria: Age ≥18 years. Coronary angiography is required for patients with suspected or confirmed coronary artery disease. The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent. Angiographic Inclusion Criteria: Diameter stenosis of 30%-90% by visual estimate Reference vessel size ≥2 mm in stenotic segment by visual estimate Exclusion Criteria: Patients meeting any of the following criteria will be excluded: General Exclusion Criteria: Subject has undergone CABG of the target vessel. Evidence of an acute myocardial infarction within one week prior to the intended procedure. Severe heart failure (NYHA≥III) Patients with other serious conditions not eligible for clinical trials, such as severe arrhythmia or tachycardia, sinus syndrome, asthma, severe chronic obstructive pulmonary disease. Serum creatinine level of >150µmol / L. Subject has known allergy to iodinated contrast agents, adenosine, or ATP. Pregnant or breastfeeding. Repeated enrollment. Any other factors that the researchers consider not suitable for diagnostic intervention or FFR and IMR detection, such as the target vessel has collateral circulation, coronary spasm, the target vessel plaque rupture resulting in myocardial infarction, or other reasons deemed unsuitable for inclusion. Angiographic Exclusion Criteria: Myocardial bridge or coronary artery fistula on the study lesions. The target lesion ≥50% diameter stenosis in the left main coronary artery or ostial lesions less than 3 mm to the RCA. Low-quality angiography with poor contrast agent filling or inability to detect vascular boundaries due to various reasons, vascular overlap or severe distortion of the target vessel to fully expose the lesion location is not expected to be calculated.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| AngioQFA<br> | Other: AngioQFA<br>* FFR measured by pressure wire, AngioQFA computed by coronary angiographic images<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic sensitivity of AngioQFA versus wire-based FFR for demonstration of coronary ischemia on a per-patient basis. | Positive FFR is defined as FFR≤0.80. Positive AngioQFA is defined as AngioQFA≤0.80. | 1 hour | 
| Diagnostic sensitivity of AngioIMR versus wire-based IMR for demonstration of coronary microvascular dysfunction on a per-patient basis. | Positive IMR is defined as IMR≥25. Positive AngioIMR is defined as AngioIMR≥25. | 1 hour | 
| Diagnostic specificity of AngioQFA versus wire-based FFR for demonstration of coronary ischemia on a per-patient basis. | Negative FFR is defined as FFR>0.80. Negative AngioQFA is defined as AngioQFA>0.80. | 1 hour | 
| Diagnostic specificity of AngioIMR versus wire-based IMR for demonstration of coronary microvascular dysfunction on a per-patient basis. | Negative IMR is defined as IMR<25. Negative AngioIMR is defined as AngioIMR<25. | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy, positive predictive value and negative predictive value of AngioQFA versus wire-based FFR for demonstration of coronary ischemia on a per-patient basis. | Diagnostic accuracy, positive predictive value and negative predictive value of AngioQFA versus wire-based FFR for demonstration of coronary ischemia on a per-patient basis. | 1 hour | 
| Diagnostic performance of AngioQFA in comparison to FFR on a per-vessel basis. | Diagnostic performance includes sensitivity, specificity, accuracy, positive predictive value and negative predictive value. | 1 hour | 
| AUC and ROC of AngioQFA Versus wire-based FFR for demonstration of ischemia on a per-vessel basis and a per-patient basis. | AUC and ROC of AngioQFA Versus wire-based FFR for demonstration of ischemia on a per-vessel basis and a per-patient basis. | 1 hour | 
| The consistency of AngioQFA Versus wire-based FFR for demonstration of ischemia on a per-vessel basis and a per-patient basis. | The consistency of AngioQFA Versus wire-based FFR for demonstration of ischemia on a per-vessel basis and a per-patient basis. | 1 hour | 
| Diagnostic accuracy, positive predictive value and negative predictive value of AngioIMR versus wire-based IMR for demonstration of coronary microvascular dysfunction on a per-patient basis. | Diagnostic accuracy, positive predictive value and negative predictive value of AngioIMR versus wire-based IMR for demonstration of coronary microvascular dysfunction on a per-patient basis. | 1 hour | 
| Diagnostic performance of AngioIMR in comparison to IMR on a per-vessel basis. | Diagnostic performance includes sensitivity, specificity, accuracy, positive predictive value and negative predictive value. | 1 hour | 
| AUC and ROC of AngioIMR Versus wire-based IMR for demonstration of coronary microvascular dysfunction on a per-vessel basis and a per-patient basis. | AUC and ROC of AngioIMR Versus wire-based IMR for demonstration of coronary microvascular dysfunction on a per-vessel basis and a per-patient basis. | 1 hour | 
| The consistency of AngioIMR Versus wire-based IMR for demonstration of coronary microvascular dysfunction on a per-vessel basis and a per-patient basis. | The consistency of AngioIMR Versus wire-based IMR for demonstration of coronary microvascular dysfunction on a per-vessel basis and a per-patient basis. | 1 hour | 
| Diagnostic sensitivity and specificity of AngioQFA and QCA DS% versus wire-based FFR for demonstration of coronary ischemia. | FFR≤0.80 is defined as positive, FFR>0.80 is defined as negative; DS%≥50% is defined as positive, DS%<50% is defined as negative. | 1 hour | 
| Diagnostic accuracy of AngioQFA versus wire-based FFR for demonstration of coronary ischemia after PCI. | Postoperative FFR≤0.89 was defined as positive, FFR>0.89 is defined as negative. | 1 hour | 
| The Pearson correlation coefficient and consistency of AngioQFA Versus wire-based FFR for demonstration of ischemia on a per-vessel basis after PCI. | The Pearson correlation coefficient and consistency of AngioQFA Versus wire-based FFR for demonstration of ischemia on a per-vessel basis after PCI. | 1 hour |