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

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06039748
• Other study ID #: The FAIR Study
• Status: Not yet recruiting
• Start date: September 11, 2023
• Est. completion date: October 30, 2024

Study information

• Verified date: September 2023
• Source: Shenzhen Raysight Intelligent Medical Technology Co., Ltd.
• Contact: Lihui Li
• Phone: 13636480344
• Email: lihui.li[@]raysightmed.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 330
• Est. completion date: October 30, 2024
• Est. primary completion date: October 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arteriosclerosis
• Cardiovascular Diseases
• Coronary Artery Disease
• Coronary Stenosis
• Heart Diseases
• Ischemia
• Vascular Diseases

Intervention

Other:
• AngioQFA
FFR measured by pressure wire, AngioQFA computed by coronary angiographic images

Locations

Country	Name	City	State
n/a

Sponsors (6)

Lead Sponsor	Collaborator
Shenzhen Raysight Intelligent Medical Technology Co., Ltd.	Jieyang People's Hospital, Renmin Hospital of Wuhan University, Sir Run Run Shaw Hospital, The Eighth Affiliated Hospital of Sun Yat-sen University, Yan'an Affiliated Hospital of Kunming Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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