Study on Coronary Artery Disease: Evaluating Myocardial Blood Flow Using SYN2, Regadenoson, and Adenosine in Patients with Heart Conditions

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What is this study about?

This clinical trial is focused on studying Coronary Artery Disease, a condition where the heart’s blood vessels are narrowed or blocked, which can lead to chest pain or heart attacks. The study will use a new treatment called SYN2, which is a solution for injection. This treatment will be compared to a standard imaging method using 13N-ammonia PET scans, which are special imaging tests that help visualize blood flow in the heart.

The purpose of the study is to understand how well SYN2 can measure blood flow in the heart compared to the traditional method. Participants will receive injections of SYN2 and undergo imaging tests to see how the blood flows through their heart. Some participants may also receive a different medication called Rapiscan or Adenosine, which are also solutions for injection, to help with the imaging process. A placebo may be used in some cases to compare the effects of the treatments.

The study will involve several visits where participants will receive the injections and have imaging tests done. The goal is to see if SYN2 provides accurate and reliable measurements of heart blood flow, which could help improve the diagnosis and treatment of Coronary Artery Disease in the future. Participants will be monitored closely throughout the study to ensure their safety and well-being.

1 consent and initial assessment

Upon joining the study, you will be asked to provide a signed and dated informed consent form. This confirms your willingness to participate and your understanding of the study procedures.

You will undergo an initial assessment to ensure you meet the study’s eligibility criteria. This includes confirming your age, medical condition, and ability to comply with study procedures.

2 preparation for imaging

You will be required to adhere to specific lifestyle considerations throughout the study. This includes abstaining from sexual intercourse at least 24 hours before and after the tracer administration.

If you are a female of reproductive potential, you must agree to use highly effective contraception during the study and for 3 months after the last investigational medicine product administration. Males must use condoms or other effective contraception methods with a partner.

3 imaging procedures

You will undergo a clinically indicated 13N-ammonia PET study if not done within 30 days prior to consenting. This imaging helps assess myocardial blood flow.

You will also participate in the SYN2 dynamic PET imaging study. This involves the administration of SYN2 and possibly other substances like regadenoson or adenosine as solutions for injection.

4 medication administration

During the imaging procedures, you may receive medications such as Rapiscan 400 microgram solution for injection, SYN2, or Adenosine 6 mg/2 ml solution for injection. These are administered to help visualize blood flow in the heart.

The administration of these medications will be done through an injection or infusion, as required by the study protocol.

5 follow-up and monitoring

After the imaging procedures, you will be monitored for any immediate reactions to the medications or procedures.

You may be asked to return for follow-up visits to assess the outcomes of the study and ensure your well-being.

Who Can Join the Study?

The person must be willing and able to provide a signed and dated consent form before any study-related procedures.
Agreement to follow specific lifestyle guidelines throughout the study.
Must be a male or female over 18 years of age.
Must be a patient with suspected Coronary Artery Disease (CAD).
The patient must have had a 13N-ammonia PET study (a type of heart imaging test) within 30 days before giving consent and not have made significant changes in heart-related treatment or undergone heart procedures after the test, OR the patient must be willing to undergo both the 13N-ammonia and SYN2 study for this clinical trial.
The person must be able and willing to follow all study procedures as described in the study plan.
Must be capable of undergoing stress imaging protocols, which may involve medication or exercise to test heart function.
Must agree to avoid sexual intercourse for at least 24 hours before and after the tracer (a special substance used in imaging tests) is given.
For females who can become pregnant: must agree to use highly effective birth control during the study and for 3 months after the last dose of the study medicine.
For males who can father children: must use condoms or other methods to ensure effective birth control with a partner.

Who Cannot Join the Study?

Patients with Coronary Artery Disease cannot participate. This is a condition where the blood vessels that supply blood to the heart become narrow or blocked.
Patients who are part of a vulnerable population are not eligible. This term refers to groups of people who may be at a higher risk of harm or exploitation, such as children, pregnant women, or those with certain disabilities.

Where you can join this trial?

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Other Sites

Site Name	City	Country
Affidea Sp. z o.o.	Warsaw	Poland
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy	Warsaw	Poland
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach	Kielce	Poland

Trial status

Country	Status	Recruitment Start
Poland	Recruiting	01.12.2023

Trial locations

Investigated drugs:

SYN2 is a new imaging agent being tested in this clinical trial. It is used in a special type of heart scan called a PET scan, which helps doctors see how well blood is flowing to the heart muscle. The goal of using SYN2 is to measure the blood flow in the heart more accurately. This can help doctors understand if there are any problems with the heart’s blood supply and how severe they might be. In this trial, SYN2 is being compared to another imaging agent to see how well it works in measuring blood flow.

Investigated diseases:

Coronary artery disease

Coronary Artery Disease – Coronary Artery Disease is a condition where the major blood vessels that supply the heart with blood, oxygen, and nutrients become damaged or diseased. This is primarily due to the buildup of cholesterol-containing deposits, known as plaques, on the artery walls, leading to atherosclerosis. As the plaques accumulate, they narrow the coronary arteries, reducing blood flow to the heart. This reduced blood flow can cause chest pain, known as angina, or lead to a heart attack if the blood flow is severely restricted or blocked. Over time, the heart may become weakened, leading to heart failure or arrhythmias. The disease progresses gradually and can be influenced by lifestyle factors such as diet, exercise, and smoking.

Trial ID:

2023-507520-23-00

Protocol code:

SAFER2a

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Coronary Artery Disease: Evaluating Myocardial Blood Flow Using SYN2, Regadenoson, and Adenosine in Patients with Heart Conditions

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?