NCT06039748 - Angiography-Derived Quantitative Functional Assessment Versus Pressure-Derived FFR and IMR: The FAIR Study | Crick

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 1 hour

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 1 hour

The consistency of AngioQFA Versus wire-based FFR for demonstration of ischemia on a per-vessel basis and a per-patient basis.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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".

Time frame: 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".

Time frame: 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.

Time frame: 1 hour

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

Overview

Conditions

Interventions

Eligibility

Locations (5)

Outcomes

Primary Outcomes

Secondary Outcomes