Absolute quantification of myocardial blood flow in human subjects with SYN2 dynamic PET imaging
EU CTIS ID: 2023-507520-23-00
What this study is testing
To enable and validate quantitative MBF assessment for SYN2 by establishing the relationship of the basic kinetic SYN2 parameters with the reference flow values from quantitative 13N-ammonia PET MPI dynamic flow studies.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- The subject must be willing and able to provide signed and dated informed consent form prior to any study related procedures.
- 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.
- The patient agrees to receive the maximal total radiation dose up to 10 mSv during diagnostic procedures.
- Agreement to adhere to Lifestyle Considerations (see section 6.4) throughout the study duration.
- Male or female, over 18 years of age.
- Patient with CAD suspicion based on symptoms and/or ECG changes as assessed by the referring physician.
You likely can't join if
- 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.
See the full eligibility criteria
- The subject must be willing and able to provide signed and dated informed consent form prior to any study related procedures.
- 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.
- The patient agrees to receive the maximal total radiation dose up to 10 mSv during diagnostic procedures.
- Agreement to adhere to Lifestyle Considerations (see section 6.4) throughout the study duration.
- Male or female, over 18 years of age.
- Patient with CAD suspicion based on symptoms and/or ECG changes as assessed by the referring physician.
- 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.
- The subject is able and willing to comply with all study procedures as described in the protocol.
- Must be capable of undergoing the pharmacological (adenosine or regadenoson) stress imaging (PET-CT) protocols.
- Willingness to abstain sexual intercourse at least 24 hours before and after the tracer administration.
- For females of reproductive potential: use of sufficiently effective contraception during study participation (from Screening) and for 30 days after the last IMP administration.
- 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.
- Known allergy or hypersensitivity for 13N-ammonia (there is no carrier)
The study team makes the final eligibility decision.
Where it's taking place
- Poland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Poland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from EU CTIS. The study team decides eligibility, and your own doctor gives medical advice.