SYN2 for Coronary artery disease

Inclusion criteria

• {"criterion_text":"- The subject must be willing and able to provide signed and dated informed consent form prior to any study related procedures.\n- For males of reproductive potential: use of condoms or other methods to ensure effective contraception with a partner for 90 days after last IMP exposure.\n- The patient agrees to receive the maximal total radiation dose up to 10 mSv during diagnostic procedures.\n- Agreement to adhere to Lifestyle Considerations (see section 6.4) throughout the study duration.\n- Male or female, over 18 years of age.\n- Patient with CAD suspicion based on symptoms and/or ECG changes as assessed by the referring physician.\n- 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 clinically indicated 13N-ammonia and SYN2 study for the purposes of this clinical study.\n- The subject is able and willing to comply with all study procedures as described in the protocol.\n- Must be capable of undergoing the pharmacological (adenosine or regadenoson) stress imaging (PET-CT) protocols.\n- Willingness to abstain sexual intercourse at least 24 hours before and after the tracer administration.\n- For females of reproductive potential: use of sufficiently effective contraception during study participation (from Screening) and for 30 days after the last IMP administration."}

Exclusion criteria

• {"criterion_text":"- 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.\n- Patients incapable of undergoing pharmacological cardiac stress testing.\n- 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.\n- Documented history of heart failure and/or cardiomyopathy and/or prior LV ejection fraction (LVEF) <40%).\n- Patients undergoing evaluation for heart transplantation or with history of heart transplantation.\n- 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.\n- Female subject has a positive (+) pregnancy test, the possibility of pregnancy cannot be ruled out prior to dosing, or the subject is breast-feeding.\n- Known allergy or hypersensitivity for SYN2 components and other acridine derivatives such as Aminacrine, Ethacridine and Euflavine.\n- Known allergy or hypersensitivity for 13N-ammonia (there is no carrier)"}

Primary endpoints

• {"endpoint_text":"- The agreement of flow estimates between 13N-ammonia and SYN2.","definition_or_measurement_approach":"Agreement between flow estimates obtained with SYN2 and reference flow values from quantitative 13N-ammonia PET myocardial perfusion imaging (quantitative PET MPI dynamic flow studies)."}

Secondary endpoints

• {"endpoint_text":"- Variability of flow estimates as compared to 13N-ammonia due to patient characteristics (sex, weight, body weight index, hematocrit) and motion and sensitivity of flow measurements to model parameters.","definition_or_measurement_approach":"Comparison of SYN2 flow estimate variability versus 13N-ammonia with analyses stratified by patient characteristics (sex, weight, BMI, hematocrit), motion effects, and sensitivity to model parameters."}
• {"endpoint_text":"- The coefficient of variation (CV)% of repeated analyses within and between two different observers in scans performed at rest and during stress are defined.","definition_or_measurement_approach":"Calculation of within- and between-observer coefficient of variation (CV%) for repeated analyses on scans performed at rest and during stress to assess inter- and intra-observer reproducibility."}
• {"endpoint_text":"- Adverse events and reportable serious adverse events during the resting study as defined by the NCI Common Toxicity Criteria for Adverse Events; CTCAE v.5.0.","definition_or_measurement_approach":"Safety assessed by recording adverse events and serious adverse events during the resting study, classified according to NCI CTCAE v5.0."}

Poland

Earliest CTIS Part Ii Submission Date

03-12-2023

Latest Decision Or Authorization Date

23-03-2026

Processing Time Days

841

Number Of Sites

3

Number Of Participants

30

Primary sponsor

Full Name

Synektik S.A.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Poland