Ocena wartości Diagnostycznej Cardiolens® Platform zawierającej Produkty FFR-CT Pro i Perfusion, służącej Kompleksowej, Nieinwazyjnej Anatomiczno - czynnościowej Diagnostyce Choroby wieńcowej
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 150
- Locations
- 8
- Primary Endpoint
- Diagnostic accuracy (AUC ROC) of the Cardiolens® Platform for detecting coronary stenoses eligible for prognostic revascularization (>10% ischemia)
Study Overview
Brief Summary
A prospective, confirmatory, multicenter, open-label clinical investigation of a Class IIa medical device (in accordance with Article 62 of Regulation 2017/745), conducted to confirm the performance of the Cardiolens® Platform, which is based on a non-invasive, combined anatomical and functional assessment (intention-to-diagnose) using CCTA in patients with suspected chronic coronary syndrome (CCS).
The introduction of the new diagnostic method - the Cardiolens® Platform - will benefit enrolled patients by reducing the number of diagnostic procedures, including invasive procedures, that currently provide equivalent diagnostic information for the identification of significant coronary stenoses qualifying for prognostic revascularization (i.e., those causing large areas of ischemia).
Virtual simulations and results generated by the Cardiolens® Platform will be compared with reference data from standard procedures performed in each participant and with actual clinical decisions made based on routine diagnostic methods. Therefore, no control group has been deemed necessary for this study. Additionally, simulations related to the assessment (results) of FFRCT and MBF-CT obtained using the Cardiolens® Platform will be blinded with respect to participant data and randomly assigned to investigators for final evaluation of ischemia significance.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 18-90 years.
- •Signed informed consent to participate in the study.
- •Positive medical history suggestive of chronic coronary syndrome (CCS).
- •Diagnostic CCTA performed no more than 122 days prior to the planned ICA, of sufficient quality to assess the entire coronary tree (both arteries reconstructable in a single series), demonstrating at least one ≥50% stenosis in an epicardial coronary artery >2.0 mm in diameter, not previously revascularized.
- •Planned ICA with the intention to perform FFR measurement no later than 122 days after the CCTA.
- •Stable treatment for CCS without the need for dose adjustments for at least 30 days prior to study inclusion.
Exclusion Criteria
- •Presence of myocardial bridging on CCTA causing >50% systolic narrowing of an epicardial coronary artery, per Investigator's assessment.
- •Complications occurring during CCTA that reduce the safety or feasibility of CTP (per treating physician decision).
- •Stenosis of the left main coronary artery >40%.
- •Myocardial infarction occurring between CCTA and ICA, documented by elevated cardiac biomarkers (troponin, myoglobin) or new wall motion abnormalities or new coronary occlusion.
- •History of asthma or chronic obstructive pulmonary disease requiring bronchodilators or steroid therapy within the last 90 days. Not applicable to patients undergoing functional testing with regadenoson.
- •Atrioventricular block (type II-III), prolonged QT interval, or sick sinus syndrome.
- •Renal insufficiency (creatinine ≥1.6 and/or glomerular filtration rate <30 ml/m²) or renal failure requiring dialysis.
- •Persistent atrial fibrillation.
- •Implanted pacemaker or internal cardioverter-defibrillator.
- •Pregnancy or inability to exclude pregnancy.
- •Hemodynamic instability per treating physician, including but not limited to: cardiogenic shock, hypotension (systolic blood pressure <90 mmHg), treatment-resistant hypertension (systolic blood pressure >180 mmHg), sustained ventricular or atrial arrhythmia requiring intravenous medication.
- •Significant allergies or adverse reactions (per Investigator) to iodinated contrast agents, adenosine, regadenoson, or aminophylline. Contraindications include: anaphylactic shock, angioedema.
- •Significant valvular heart disease-at least moderate regurgitation or stenosis.
- •Structural heart disease, including post-corrective procedures.
- •Malignant coronary artery anomaly.
- •History of myocardial infarction.
- •Prior coronary artery bypass grafting (CABG).
- •Prior PCI if the target vessel for evaluation has previously undergone PCI.
- •Chronic total occlusion (CTO) of a coronary artery.
- •Left ventricular ejection fraction (LVEF) ≤35%.
- •Presence of conditions that, in the Investigator's opinion, may significantly change the patient's health status within 122 days.
- •Other relevant comorbidities, infections, addictions, or psychological or social factors that, in the Investigator's opinion, may impair participation in the study or significantly affect patient safety.
Arms & Interventions
Standard of care: FFR, ICA, CCTA
Patients with medical history for ischaemic heart disease will take part in non-invasive determination of haemodynamic parameters in coronary arteries with Cardiolens FFR-CT Pro technology.
Intervention: CCTA (Coronary Computed Tomography Angiography) (Procedure)
Standard of care: FFR, ICA, CCTA
Patients with medical history for ischaemic heart disease will take part in non-invasive determination of haemodynamic parameters in coronary arteries with Cardiolens FFR-CT Pro technology.
Intervention: ICA (Invasive Coronary Angiography) (Procedure)
Standard of care: FFR, ICA, CCTA
Patients with medical history for ischaemic heart disease will take part in non-invasive determination of haemodynamic parameters in coronary arteries with Cardiolens FFR-CT Pro technology.
Intervention: FFR (Fractional Flow Reserve) (Procedure)
Standard of care: FFR, ICA, CCTA
Patients with medical history for ischaemic heart disease will take part in non-invasive determination of haemodynamic parameters in coronary arteries with Cardiolens FFR-CT Pro technology.
Intervention: CNBP measurement (Device)
Standard of care: FFR, ICA, CCTA
Patients with medical history for ischaemic heart disease will take part in non-invasive determination of haemodynamic parameters in coronary arteries with Cardiolens FFR-CT Pro technology.
Intervention: Cardiolens Platform (Device)
Outcomes
Primary Outcomes
Diagnostic accuracy (AUC ROC) of the Cardiolens® Platform for detecting coronary stenoses eligible for prognostic revascularization (>10% ischemia)
Time Frame: Up to 18 months
Assessment of diagnostic accuracy (AUC ROC) of the Cardiolens® Platform for identifying vessels with functionally significant stenosis requiring prognostic revascularization (\>10% ischemia), using ICA + FFR + CTP as the reference standard. Per-vessel, intention-to-diagnose analysis. Unit of measure: AUC ROC (0-1 scale) Measurement tools: Cardiolens® Platform vs reference: ICA + FFR (≤0.80) + CTP (\>10% ischemia)
Secondary Outcomes
- Exploratory accuracy of the Cardiolens® Platform for detecting coronary microvascular dysfunction(18 months)
- Sensitivity, specificity, PPV, NPV, and accuracy of the Cardiolens® Platform for detecting functionally significant stenoses(Up to 18 months)
- AUC ROC comparison between Cardiolens® Platform and standard imaging modalities for identifying arteries requiring revascularization(18 months)
- Agreement between SYNTAX Score calculated from CCTA, functional SYNTAX Score from CCTA+FFRCT, and functional SYNTAX Score from CCTA+Cardiolens®, referenced to ICA+FFR(18 months)
- Diagnostic accuracy of the Cardiolens® Platform on a per-patient level(18 months)
- Diagnostic accuracy of the Cardiolens® Platform for predicting performed coronary revascularization (per-patient)(18 months)
- Diagnostic accuracy of the Cardiolens® Platform for predicting performed coronary revascularization (per-vessel)(18 months)