Clinical trial NCT06039748: Angiography-Derived Quantitative Functional Assessment Versus Pressure-Derived FFR and IMR: The FAIR Study
Official title: Diagnostic Performance of Angiography-Derived Quantitative Functional Assessment Compared to Pressure-Derived Fractional Flow Reserve and Index of Microcirculatory Resistance: The FAIR Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Coronary Stenosis
Vascular Diseases
Ischemia
Lead sponsor: Shenzhen Raysight Intelligent Medical Technology Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Renmin Hospital of Wuhan University
name: Yan'an Affiliated Hospital of Kunming Medical University
name: Sir Run Run Shaw Hospital
name: Jieyang People's Hospital
name: Eighth Affiliated Hospital, Sun Yat-sen University
First posted: 2023-09-15
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with coronary artery disease admitted for coronary angiography due to high risk of significant coronary stenosis

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Diagnostic sensitivity of AngioQFA versus wire-based FFR for demonstration of coronary ischemia on a per-patient basis.
timeFrame: 1 hour
measure: Diagnostic sensitivity of AngioIMR versus wire-based IMR for demonstration of coronary microvascular dysfunction on a per-patient basis.
timeFrame: 1 hour
measure: Diagnostic specificity of AngioQFA versus wire-based FFR for demonstration of coronary ischemia on a per-patient basis.
timeFrame: 1 hour
measure: Diagnostic specificity of AngioIMR versus wire-based IMR for demonstration of coronary microvascular dysfunction on a per-patient basis.
timeFrame: 1 hour
Secondary outcomes:
measure: 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.
timeFrame: 1 hour
measure: Diagnostic performance of AngioQFA in comparison to FFR on a per-vessel basis.
timeFrame: 1 hour
measure: AUC and ROC of AngioQFA Versus wire-based FFR for demonstration of ischemia on a per-vessel basis and a per-patient basis.
timeFrame: 1 hour
measure: The consistency of AngioQFA Versus wire-based FFR for demonstration of ischemia on a per-vessel basis and a per-patient basis.
timeFrame: 1 hour
measure: 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.
timeFrame: 1 hour
measure: Diagnostic performance of AngioIMR in comparison to IMR on a per-vessel basis.
timeFrame: 1 hour
measure: 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.
timeFrame: 1 hour
measure: The consistency of AngioIMR Versus wire-based IMR for demonstration of coronary microvascular dysfunction on a per-vessel basis and a per-patient basis.
timeFrame: 1 hour
measure: Diagnostic sensitivity and specificity of AngioQFA and QCA DS% versus wire-based FFR for demonstration of coronary ischemia.
timeFrame: 1 hour
measure: Diagnostic accuracy of AngioQFA versus wire-based FFR for demonstration of coronary ischemia after PCI.
timeFrame: 1 hour
measure: The Pearson correlation coefficient and consistency of AngioQFA Versus wire-based FFR for demonstration of ischemia on a per-vessel basis after PCI.
timeFrame: 1 hour
Other outcomes:
Locations:
city: Jieyang
country: China
facility: Jieyang People's Hospital
state: Guangdong
city: Shenzhen
country: China
facility: The Eighth Affiliated Hospital of Sun Yat-Sen University
state: Guangdong
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
state: Hubei
city: Kunming
country: China
facility: Yan'an Affiliated Hospital of Kunming Medical University
state: Yunnan
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital
state: Zhejiang
Study officials:
affiliation: Renmin Hospital of Wuhan University
name: Hong Jiang
role: STUDY_DIRECTOR
affiliation: Yan'an Affiliated Hospital of Kunming Medical University
name: Qiang Xue
role: PRINCIPAL_INVESTIGATOR
affiliation: Sir Run Run Shaw Hospital
name: Guosheng Fu
role: PRINCIPAL_INVESTIGATOR
affiliation: The Eighth Affiliated Hospital of Sun Yat-sen University
name: Jianwen Liang
role: PRINCIPAL_INVESTIGATOR
affiliation: Jieyang People's Hospital
name: Qiang Wu
role: PRINCIPAL_INVESTIGATOR
References: