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| Name | Class |
|---|---|
| Renmin Hospital of Wuhan University | OTHER |
| Yan'an Affiliated Hospital of Kunming Medical University | OTHER |
| Sir Run Run Shaw Hospital | OTHER |
| Jieyang People's Hospital |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AngioQFA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AngioQFA | Other | FFR measured by pressure wire, AngioQFA computed by coronary angiographic images |
|
| 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 |
| 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 |
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Inclusion Criteria
General Inclusion Criteria:
Angiographic Inclusion Criteria:
Exclusion Criteria:
Patients meeting any of the following criteria will be excluded:
General Exclusion Criteria:
Angiographic Exclusion Criteria:
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Patients with coronary artery disease admitted for coronary angiography due to high risk of significant coronary stenosis
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| Name | Affiliation | Role |
|---|---|---|
| Hong Jiang | Renmin Hospital of Wuhan University | Study Director |
| Qiang Xue | Yan'an Affiliated Hospital of Kunming Medical University | Principal Investigator |
| Guosheng Fu | Sir Run Run Shaw Hospital | Principal Investigator |
| Jianwen Liang | The Eighth Affiliated Hospital of Sun Yat-sen University | Principal Investigator |
| Qiang Wu | Jieyang People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jieyang People's Hospital | Jieyang | Guangdong | China | |||
| The Eighth Affiliated Hospital of Sun Yat-Sen University |
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| OTHER |
| Eighth Affiliated Hospital, Sun Yat-sen University | OTHER |
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| 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 |
| Shenzhen |
| Guangdong |
| 518033 |
| China |
| Renmin Hospital of Wuhan University | Wuhan | Hubei | 430090 | China |
| Yan'an Affiliated Hospital of Kunming Medical University | Kunming | Yunnan | 650051 | China |
| Sir Run Run Shaw Hospital | Hangzhou | Zhejiang | 310013 | China |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D023921 | Coronary Stenosis |
| D014652 | Vascular Diseases |
| D007511 | Ischemia |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D001157 | Arterial Occlusive Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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