Vertaisarvioitu alkuperäisartikkeli tai data-artikkeli tieteellisessä aikakauslehdessä (A1)
Assessing myocardial perfusion in suspected coronary artery disease: rationale and design of the second phase 3, open-label multi-center study of flurpiridaz (F-18) injection for positron emission tomography (PET) imaging
Julkaisun tekijät: Bourque Jemieson M, Hanson Christopher A, Agostini Denis, Bateman Timothy M, Bax Jeroen J, Beanlands Rob SB, Berman Daniel S, Garcia Ernest V, Heller Gary V, Knuuti Juhani, Tamaki Nagara, Udelson James E, Maddahi Jamshid
Kustantaja: SPRINGER
Julkaisuvuosi: 2021
Journal: Journal of Nuclear Cardiology
Tietokannassa oleva lehden nimi: JOURNAL OF NUCLEAR CARDIOLOGY
Lehden akronyymi: J NUCL CARDIOL
Volyymi: 28
Sivujen määrä: 12
ISSN: 1071-3581
eISSN: 1532-6551
DOI: http://dx.doi.org/10.1007/s12350-021-02527-8
Background
Positron emission tomography (PET) myocardial perfusion imaging (MPI) with the novel radiopharmaceutical Fluorine-18 Flurpiridaz has been shown in Phase 1, 2, and first Phase 3 clinical studies to be safe and effective in diagnosing coronary artery disease (CAD). We describe the methodology of the second FDA-mandated phase 3 prospective, open-label, international, multi-center trial of F-18 Flurpiridaz PET MPI.
Methods
The primary study end point is to assess the diagnostic efficacy of F-18 Flurpiridaz PET MPI in the detection of significant CAD [>= 50% by quantitative invasive coronary angiography (ICA)] in patients with suspected CAD. The secondary endpoints are to evaluate the diagnostic efficacy of F-18 Flurpiridaz PET MPI compared to Tc-99 m-labeled SPECT MPI in the detection of CAD in all patients and in the following subgroups: (1) females; (2) patients with body mass index >= 30 kg/m(2); and (3) diabetic patients. This trial's design differs from the first phase 3 trial in that (1) comparison to SPECT is now a secondary end point; (2) patients with known CAD are excluded; and (3) both SPECT and PET MPI are performed before ICA.
Conclusions
This second phase 3 study will provide additional evidence on the diagnostic efficacy of F-18 Flurpiridaz PET MPI in the detection of significant CAD.
