Status:
COMPLETED
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.
Lead Sponsor:
Hemolens Diagnostics Sp. z o.o.
Collaborating Sponsors:
GENELYTICA Sp. z o.o.
Conditions:
Stable Ischemic Heart Disease
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Brief Summary
A multicentre, post-marketing, observational trial in 450 patients, whose standard diagnostic workup for chronic coronary syndromes provided for Invasive Coronary Angiography (ICA). Medical records of...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Age ≥ 18
- Declaration of informed consent to sharing medical records gathered during the standard diagnostic workup
- History of chronic coronary syndromes (CCS)
- 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
- Standard treatment of chronic coronary syndromes with no dosage modification required within at least 4 weeks before the enrolment
- 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
- CCTA-confirmed myocardial bridges causing \>50% stenosis of the epicardial vascular lumen
- Coronary obstruction confirmed by CCTA or invasive coronarography
- History of ACS with coronary angioplasty or Coronary Artery Bypass Grafting (CABG) performed unless point 6 conditions are met
- Significant haemodynamic abnormalities of the valve or history of surgical correction of the defect or CABG
- Second-degree or third-degree atrioventricular block, sinus node dysfunction, QTc \> 450 ms or prolonged QTc
- LVEF ≤ 35% found in an echocardiogram performed within the last 6 months
- BMI ≥ 35
- Clinically apparent infection
- Thrombocytopenia below 100.000/mm3
- 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
- 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
Key Trial Info
Start Date :
August 6 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 31 2023
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT04777513
Start Date
August 6 2020
End Date
May 31 2023
Last Update
May 16 2024
Active Locations (11)
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1
American Heart of Poland, Centrum Kardiologii i Kardiochirurgii w Bielsku-Białej
Bielsko-Biala, Poland, 43-316
2
The University Clinical Centre
Gdansk, Poland
3
The Leszek Giec Upper-Silesian Medical Centre of the Silesian Medical University
Katowice, Poland
4
Oddział Kliniczny Kardiologii oraz Interwencji Sercowo-Naczyniowych Szpital Uniwersytecki w Krakowie
Krakow, Poland, 30-688