Evaluation of Diagnostic Accuracy, Safety, and Cost-Effectiveness of the Non-Invasive Cardiolens FFR-CT Pro Method to Measure the Fractional Flow Reserve in Diagnostics of Chronic Coronary Syndromes Versus the Standard Diagnostic Modalities. A Multicentre Post-marketing Trial of a Class 2a Medical Device, Cardiolens FFR-CT Pro - Software for Non-invasive Determination of Haemodynamic Parameters in Coronary Arteries.
Data Collection
Collected from today forward - ProspectiveArterial Occlusive Diseases+5
+ Arteriosclerosis
+ Cardiovascular Diseases
Case-Only
Examining characteristics of individuals with a disease in order to identify genetic or environmental factors contributing to the condition.Summary
Study start date: August 6, 2020
Actual date on which the first participant was enrolled.Stage 1 After a patient declares their consent, a doctor or another member of the study team trained by the sponsor will perform procedures in the following order: * Define the unique patient ID to be recorded in the CRF with the patient's demographic data * Assess the quality of CCTA imaging data (DICOM) according to guidelines agreed upon with the sponsor and record the number and location of the significant (≥50%) stenosis sites in the CRF based on CCTA * No later than one hour before ICA starts, perform a physical examination consisting in instantaneous peripheral blood pressure (systolic and diastolic) resting measurement performed with a standard sphygmomanometer and Continuous Non-Invasive Blood Pressure measurement (1-3 min). Stage 2 After the procedures mentioned above are performed, the patient will undergo elective ICA with the outcomes, i.e.: * video material showing the location of the wire during the FFR measurement, * digital pressure signals exported from the FFR measuring device used to determine the value of the invasive FFR, * values of FFR measurements obtained during ICA will be entered after being anonymised in a dedicated HEMOFLOW PMS\_2020 reference database. Stage 3 Within 48 hours of ICA completion a doctor or another member of the study team trained by the sponsor: * will enter the following data in the Cardiolens FFR-CT Pro system: 1. Patient's data, i.e. patient's ID, gender, height, body mass, exercise tolerability, information on used medications and smoking cigarettes. Optionally, i.e. if upon admission for ICA a blood test was performed as a part of the standard diagnostic workup - haematocrit levels and total protein concentration 2. Files containing CCTA imaging data in the DICOM format. 3. Values of instantaneous peripheral blood pressure (systolic and diastolic) resting measurement performed with a standard sphygmomanometer as well as the digital signal obtained during the CNBP measurement (1-3 min) * Based on the CCTA description or meta data contained in the imaging data the doctor or another member of the study team will record the following information in the CRF: 1. Radiation dose during CCTA 2. Contrast medium dose during CCTA * Will enter the following information in the CRF: 1. Radiation dose during the diagnostic part of ICA 2. Contrast medium dose during the diagnostic part of ICA 3. Number and type of adverse events 4. Duration of the diagnostic workup. Stage 4 Within 7 days of entering all the stage 3 data the investigator (a cardiologist) trained by the sponsor will measure the value of the virtual FFR with the Cardiolens FFR-CT Pro system at locations corresponding to ICA FFR measurements (based on video recording entered in the database during stage 2) Based on results obtained from the Cardiolens FFR-CT Pro system vs reference data an analysis will be performed on meeting the primary and secondary end points of the trial.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.450 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Case-only
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: 1. Age ≥ 18 2. Declaration of informed consent to sharing medical records gathered during the standard diagnostic workup 3. History of chronic coronary syndromes (CCS) 4. Diagnostic CCTA (good quality test allowing investigation of the entire coronary artery tree), showing at least one site with stenosis ≥50% of the lumen in a large coronary artery of ≥ 2 mm diameter, with no prior revascularisation 5. Standard treatment of chronic coronary syndromes with no dosage modification required within at least 4 weeks before the enrolment 6. Patients with a prior acute coronary syndrome (ACS) or revascularisation would be found eligible under the following conditions: * Over 30 days from the acute coronary syndrome occurrence * FFR assessment during ICA may only cover the vessels that were not revascularized (both PCI and CABG) and were not the reason of ACS * No closed coronary arteries Exclusion Criteria: 1. CCTA-confirmed myocardial bridges causing \>50% stenosis of the epicardial vascular lumen 2. Coronary obstruction confirmed by CCTA or invasive coronarography 3. History of ACS with coronary angioplasty or Coronary Artery Bypass Grafting (CABG) performed unless point 6 conditions are met 4. Significant haemodynamic abnormalities of the valve or history of surgical correction of the defect or CABG 5. Second-degree or third-degree atrioventricular block, sinus node dysfunction, QTc \> 450 ms or prolonged QTc 6. LVEF ≤ 35% found in an echocardiogram performed within the last 6 months 7. BMI ≥ 35 8. Clinically apparent infection 9. Thrombocytopenia below 100.000/mm3 10. Active neoplastic disease (apart from basal cell carcinoma and carcinoma in situ) and other conditions, which, in the investigator's opinion significantly affect their life expectancy 11. Other significant conditions, infections, addictions and psychological or social factors, which, in the doctor's opinion, may affect patient's ability to participate in the trial or significantly affect their safety
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 11 locations
American Heart of Poland, Centrum Kardiologii i Kardiochirurgii w Bielsku-Białej
Bielsko-Biala, PolandOpen American Heart of Poland, Centrum Kardiologii i Kardiochirurgii w Bielsku-Białej in Google MapsThe University Clinical Centre
Gdansk, PolandThe Leszek Giec Upper-Silesian Medical Centre of the Silesian Medical University
Katowice, PolandOddział Kliniczny Kardiologii oraz Interwencji Sercowo-Naczyniowych Szpital Uniwersytecki w Krakowie
Krakow, Poland