Cardiac, CT, CT-Quantitative, Comparative studies, Ischaemia / Infarction
G. Pontone1, D. Andreini1, A. L. Bartorelli1, M. Guglielmo1, S. Mushtaq1, C. Segurini1, A. Baggiano1, E. Conte1, V. Beltrama1, A. D. Annoni2, A. Formenti1, M. Petullà1, A. I. Guaricci3; 1Milan/IT, 2Milano /IT, 3Foggia/IT
Methods and Materials
Overall study design. The PERFECTION study is a longitudinal,
prospective and consecutive cohort study to compare the feasibility and accuracy of FFRCT versus stress-CTP for the diagnosis of functionally significant CAD.
The target populations are symptomatic subjects with suspected CAD and no contra-indications to FFRCT and stress CTP who are referred for non-emergent,
clinically indicated ICA.
Exclusion criteria will include: a) low pre-test likelihood of CAD according to the updated Diamond-Forrester risk model score (22); b) prior clinically documented myocardial infarction; c) previous history of PCI and/or CABG; d) suspicion of an acute coronary syndrome; e) need of an emergent procedure within 48 hours of presentation; f) evidence of clinical instability; d) contra-indications for contrast agents or impaired renal function; e) inability to sustain a breath hold; f) pregnancy; g) cardiac arrhythmias; g) body mass index greater than 35 kg/m2.; h) presence of a pacemaker or implantable l cardioverter defibrillator ; i) contra-indications to FFRCT (complex congenital heart disease,
other than anomalous coronary origin alone,
including ventricular septal defect with Qp/Qs >1.4); l) contra-indications to the administration of sub-lingual nitrates, β-blockade and adenosine.
Figure 1 shows the study design.
We will divide the study population in four consecutive groups who will be evaluated before ICA with rest-stress static CTP (Group 1A),
stress-rest static CTP (Group 1B),
rest-stress dynamic CTP (Group 2A) and stress-rest dynamic CTP (Group 2B).
We will submit rest cCTA datasets to HeartFlow Inc.
CA) for FFRCT analysis and the results will be provided to the investigator within 24 hours.
All patients will undergo ICA and clinically indicated invasive FFR within 90 days after cCTA.
Written informed consent will be obtained from all patients.
The institutional ethical committee approved the study protocol.
The PERFECTION study is a single-center study that will enrol a total of 200 patients who will be assigned to four cohorts of 50 patients each.
The following procedures will be performed:
1) Screening procedure and enrolment
2) Rest cCTA performance and interpretation
3) FFRCT performance and interpretation (figure 2)
4) Static or dynamic stress CTP (figure 3)
5) Invasive coronary angiography and clinically indicated FFR.