Arteriosclerosis, Cardiovascular Diseases, Coronary Artery Disease, Coronary Stenosis, Heart Diseases, Ischemia, Vascular Diseases
Conditions
Brief summary
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.
Interventions
OTHERAngioQFA
FFR measured by pressure wire, AngioQFA computed by coronary angiographic images
Sponsors
Renmin Hospital of Wuhan University
Yan'an Affiliated Hospital of Kunming Medical University
Sir Run Run Shaw Hospital
Jieyang People's Hospital
Eighth Affiliated Hospital, Sun Yat-sen University
Shenzhen Raysight Intelligent Medical Technology Co., Ltd.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* General Inclusion Criteria: 1. Age ≥18 years. 2. Coronary angiography is required for patients with suspected or confirmed coronary artery disease. 3. The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent. * Angiographic Inclusion Criteria: 1. Diameter stenosis of 30%-90% by visual estimate 2. Reference vessel size ≥2 mm in stenotic segment by visual estimate
Exclusion criteria
Patients meeting any of the following criteria will be excluded: * General
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic sensitivity of AngioQFA versus wire-based FFR for demonstration of coronary ischemia on a per-patient basis. | 1 hour | Positive FFR is defined as FFR≤0.80. Positive AngioQFA is defined as AngioQFA≤0.80. |
| Diagnostic sensitivity of AngioIMR versus wire-based IMR for demonstration of coronary microvascular dysfunction on a per-patient basis. | 1 hour | Positive IMR is defined as IMR≥25. Positive AngioIMR is defined as AngioIMR≥25. |
| Diagnostic specificity of AngioQFA versus wire-based FFR for demonstration of coronary ischemia on a per-patient basis. | 1 hour | Negative FFR is defined as FFR\>0.80. Negative AngioQFA is defined as AngioQFA\>0.80. |
| Diagnostic specificity of AngioIMR versus wire-based IMR for demonstration of coronary microvascular dysfunction on a per-patient basis. | 1 hour | Negative IMR is defined as IMR\<25. Negative AngioIMR is defined as AngioIMR\<25. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 performance of AngioIMR in comparison to IMR on a per-vessel basis. | 1 hour | Diagnostic performance includes sensitivity, specificity, accuracy, positive predictive value and negative predictive value. |
| 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 | 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. |
| 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 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 sensitivity and specificity of AngioQFA and QCA DS% versus wire-based FFR for demonstration of coronary ischemia. | 1 hour | 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. |
| Diagnostic accuracy of AngioQFA versus wire-based FFR for demonstration of coronary ischemia after PCI. | 1 hour | Postoperative FFR≤0.89 was defined as positive, FFR\>0.89 is defined as negative. |
| 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 | The Pearson correlation coefficient and consistency of AngioQFA Versus wire-based FFR for demonstration of ischemia on a per-vessel basis after PCI. |
| 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 | The consistency of AngioIMR Versus wire-based IMR for demonstration of coronary microvascular dysfunction on a per-vessel basis and a per-patient basis. |
| Diagnostic performance of AngioQFA in comparison to FFR on a per-vessel basis. | 1 hour | Diagnostic performance includes sensitivity, specificity, accuracy, positive predictive value and negative predictive value. |
| 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 | AUC and ROC 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 | The consistency of AngioQFA Versus wire-based FFR for demonstration of ischemia on a per-vessel basis and a per-patient basis. |
Countries
China
Outcome results
None listed