A Phase III Prospective, Multicenter, Open-label Study to Assess Diagnostic Efficacy of a Novel 18F-labelled Tracer, SYN2, for Positron Emission Tomography in Subjects with Suspected Coronary Artery Disease

Prior treatment

• Subjects who have an established diagnosis of CAD as confirmed by any of the following: a. Previous myocardial infarction (MI); b. Previous coronary revascularization, such as percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG).
• Subjects who have taken the last dose of an Investigational Medicinal Product (IMP) from another trial within 30 days prior to enrollment in this study, and subjects scheduled to participate in another clinical study during the 7-day follow-up period of this study (except post-marketing observational clinical studies).

Other illness

• Subjects who have a mental or physical condition that prevents them from giving informed consent to participate in a clinical trial.
• Known allergy or hypersensitivity for SYN2 components and other acridine derivatives such as Aminacrine, Ethacridine and Euflavine.
• Subjects incapable of undergoing pharmacological or exercise cardiac stress testing.
• Subjects who are unable to undergo all the imaging procedures or who have a current illness or pathology that, in the opinion of the investigator, would pose a significant safety risk for the subject or for whom the participation may compromise the management of other diseases or the investigator judges to be unsuitable for participation in the study.
• Subjects with severe valvular disease (Stages C, D defined by 2020 ACC/AHA Guideline).
• Subjects scheduled for or planning to undergo any cardiac interventional procedures between enrolment and ICA (e.g., balloon angioplasty or bypass surgery).
• Subjects undergoing evaluation for heart transplantation or with a history of heart transplantation.

Lab values

• Female subjects who are pregnant, have a positive (+) pregnancy test, or the possibility of pregnancy cannot be ruled out prior to dosing, or the subject is breastfeeding. The females of childbearing potential must have a negative serum pregnancy test at screening and serum/urine pregnancy test within 4 hours prior to the imaging]
• Documented history of heart failure and/or cardiomyopathy and/or prior LV ejection fraction (LVEF) <40%).

Other

• Subjects who have been committed to an institution by virtue of an order issued either by judicial or administrative authorities.

• Provision of signed and dated informed consent form.
• Stated willingness to comply with all study procedures and availability for the duration of the study.
• Male or female, aged over 18 years of age.
• At the time of enrolment, the subject has been scheduled via written documentation to undergo an invasive coronary angiography for the assessment of CAD.
• Must be capable of undergoing the pharmacological or exercise stress imaging protocols.
• For females of reproductive potential: use of sufficiently effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional one week after the last IMP administration. A sufficient contraceptive method includes mechanical barrier (e.g., a male condom or a female diaphragm), combined [estrogen and progestogen containing] hormonal contraception associated with inhibition of ovulation [oral, intravaginal, transdermal], progestogen-only hormonal anticonception associated with inhibition of ovulation [oral, injectable, implantable], IUD or IUS. Sexual abstinence is allowed when this is the preferred and usual lifestyle of the subject.
• For males of reproductive potential: use of condoms or other methods to ensure effective contraception with a partner for 3 months after last IMP exposure.
• Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout the study duration.