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This statement from the European Association of Cardiovascular Imaging (EACVI) of the ESC aims to address the fundamental principles that guide clinical research in the field of cardiovascular imaging. It provides clinical researchers, cardiology fellows, and PhD students with a condensed, updated, and practical reference document to support them in designing, implementing, and conducting imaging protocols for clinical trials. Although the present article cannot replace formal research training and mentoring, it is recommended reading for any professional interested in becoming acquainted with or participating in clinical trials involving cardiovascular imaging. [ABSTRACT FROM AUTHOR]

Background: Coronary computed tomography angiography (CCTA) and fractional flow reserve (FFR) derived from CCTA (FFR-CT) may provide a means of reducing unnecessary invasive coronary angiography (ICA) in patients with suspected non-ST-elevation acute coronary syndromes (NSTE-ACS)., Aims: The aim of this study was to evaluate the capacity of FFR-CT and CCTA to rule out significant lesions in high-risk NSTE-ACS patients, using ICA with invasive FFR as the gold standard., Methods: High-risk NSTE-ACS patients admitted to 4 European centres were enrolled in this single-arm, prospective core lab-adjudicated study. Patients underwent CCTA with FFR-CT analysis, followed by ICA with invasive FFR., Results: Out of the 250 initially planned NSTE-ACS patients, 168 were included, of whom 151 (92%) had sufficient CCTA image quality to undergo CCTA and FFR-CT analysis. The median high-sensitivity troponin T level at 1 hour post-hospitalisation was 5.3 (interquartile range: 1.8-18.6) times the upper reference limit. At the patient level, the diagnostic performance of FFR-CT was numerically higher as compared to CCTA though not statistically significant (sensitivity: 94% vs 93%, specificity: 63% vs 54%, positive predictive value: 83% vs 79%, negative predictive value: 85% vs 80% and accuracy: 83% vs 79%; p=0.58), suggesting an enhanced capability to avoid unnecessary ICA. At the lesion level, the ability of FFR-CT to detect significant lesions was significantly better than that of CCTA (receiver operating characteristic curves: 0.84 vs 0.65 respectively; p<0.01)., Conclusions: In patients with high-risk NSTE-ACS, FFR-CT offers better diagnostic accuracy - though not statistically significant - and a higher ability to rule out haemodynamically significant stenoses as compared to CCTA. This indicates that FFR-CT can reduce unnecessary invasive procedures by more accurately identifying patients requiring further intervention.