Absolute quantification of myocardial blood flow in human subjects with SYN2 dynamic PET imaging - SAFER2a

Synektik S.A.0 sites30 target enrollmentSeptember 23, 2023

Overview

No summary available.

Registry

who.int

Start Date

September 23, 2023

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Synektik S.A.

•The subject must be willing and able to provide signed and dated informed consent form prior to any study related procedures., Agreement to adhere to Lifestyle Considerations (see section 5\.3\) throughout the study duration., Male or female, over 18 years of age., Patient with suspected CAD., The patient undergoing a clinically indicated 13N\-ammonia PET study within 30 days before informed consenting and not making significant changes in anti\-ischemic therapy or undergoing revascularization after 13N\-ammonia PET OR the patient is willing to undergo 13N\-ammonia and SYN2 study for the purposes of this clinical study., The subject is able and willing to comply with all study procedures as described in the protocol., Must be capable of undergoing the pharmacological or exercise stress imaging protocols., Willingness to abstain sexual intercourse at least 24 hours before and after the tracer administration., For females of reproductive potential: agreement to use of highly effective contraception during study participation and for 3 months after the last investigational medicine product (IMP) administration., For males of reproductive potential: use of condoms or other methods to ensure effective contraception with a partner.

•Patients who are unable to undergo all the imaging procedures based on the investigator's opinion. Reasons may be any clinically significant acute or unstable physical or psychological disease judged by the investigators based on medical history or screening physical examination., Patients incapable of undergoing pharmacological cardiac stress testing., Patients who have a current illness or pathology that, in the opinion of the investigator, would pose a significant safety risk for the patient during cardiac stress testing., Documented history of heart failure and/or cardiomyopathy and/or prior LV ejection fraction (LVEF) \<40%)., Patients undergoing evaluation for heart transplantation or with history of heart transplantation., Patients enrolled in another clinical study within the 30 days prior to being enrolled in this study or scheduled to participate in another clinical study during the 7\-day follow\-up period of this study., Female subject has a positive (\+) pregnancy test, the possibility of pregnancy cannot be ruled out prior to dosing, or the subject is breast\-feeding., Known allergy or hypersensitivity for SYN2 components and other acridine derivatives such as Aminacrine, Ethacridine and Euflavine.