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

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Wojskowy Instytut Medyczny Państwowy Instytut Badawczy
Warsaw, Poland
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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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.
Step 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.
Step 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.
Step 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.
Step 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 trial?

10 criteria

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 trial?

2 criteria

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.

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Wojskowy Instytut Medyczny Państwowy Instytut Badawczy
Warsaw, Poland
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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.

What is already known about the treatment

SYN2 – SYN2 is administered through a dynamic PET imaging technique, which involves injecting the substance into the bloodstream to visualize and measure blood flow in the heart. Currently, SYN2 is being studied in clinical trials to assess its effectiveness in quantifying myocardial blood flow, particularly in patients with coronary artery disease. The main therapeutic indication for SYN2 is to provide accurate measurements of blood flow in the heart, which can help in diagnosing and managing heart conditions. At the molecular level, SYN2 works by interacting with specific markers in the blood, allowing for precise imaging and assessment of blood flow. It is classified under pharmacological agents used in diagnostic imaging.

Investigated diseases

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.