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

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

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.

Study Overview

• Status: Completed
• Conditions: Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Artery Disease; Arteriosclerosis; Coronary Stenosis
• Intervention / Treatment: Other: AngioQFA

• Study Type: Observational
• Enrollment (Actual): 330

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Jieyang, Guangdong, China
      • Jieyang People's Hospital
    • Shenzhen, Guangdong, China, 518033
      • The Eighth Affiliated Hospital of Sun Yat-Sen University
  • Hubei
    • Wuhan, Hubei, China, 430090
      • Renmin Hospital of Wuhan University
  • Yunnan
    • Kunming, Yunnan, China, 650051
      • Yan'an Affiliated Hospital of Kunming Medical University
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310013
      • Sir Run Run Shaw Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with coronary artery disease admitted for coronary angiography due to high risk of significant coronary stenosis

Description

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 Exclusion Criteria:

  1. Subject has undergone CABG of the target vessel.
  2. Evidence of an acute myocardial infarction within one week prior to the intended procedure.
  3. Severe heart failure (NYHA≥III)
  4. Patients with other serious conditions not eligible for clinical trials, such as severe arrhythmia or tachycardia, sinus syndrome, asthma, severe chronic obstructive pulmonary disease.
  5. Serum creatinine level of >150µmol / L.
  6. Subject has known allergy to iodinated contrast agents, adenosine, or ATP.
  7. Pregnant or breastfeeding.
  8. Repeated enrollment.
  9. 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:

  1. Myocardial bridge or coronary artery fistula on the study lesions.
  2. The target lesion ≥50% diameter stenosis in the left main coronary artery or ostial lesions less than 3 mm to the RCA.
  3. 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
AngioQFA	Other: AngioQFA; FFR measured by pressure wire, AngioQFA computed by coronary angiographic images

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Shenzhen Raysight Intelligent Medical Technology Co., Ltd.
• Collaborators: Renmin Hospital of Wuhan University; Sir Run Run Shaw Hospital; Jieyang People's Hospital; Yan'an Affiliated Hospital of Kunming Medical University; Eighth Affiliated Hospital, Sun Yat-sen University
• Investigators: Principal Investigator: Qiang Xue, Yan'an Affiliated Hospital of Kunming Medical University; Study Director: Hong Jiang, Renmin Hospital of Wuhan 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

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2023
• Primary Completion (Actual): January 14, 2024
• Study Completion (Actual): January 14, 2024

Study Registration Dates

• First Submitted: September 10, 2023
• First Submitted That Met QC Criteria: September 10, 2023
• First Posted (Actual): September 15, 2023

Study Record Updates

• Last Update Posted (Actual): May 16, 2025
• Last Update Submitted That Met QC Criteria: May 13, 2025
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Cardiovascular Diseases; Heart Diseases; Vascular Diseases; Coronary Artery Disease; Coronary Stenosis; Arteriosclerosis
• Other Study ID Numbers: The FAIR Study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No