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Study on the Use of SYN2, Adenosine, and Regadenoson for Diagnosing Coronary Artery Disease in Patients with Suspected Heart Conditions

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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 a heart condition known as Coronary Artery Disease (CAD). The study will use a new treatment called SYN2, which is a special tracer used in a type of imaging test called Positron Emission Tomography (PET). This tracer is injected into the body to help doctors see how well blood is flowing to the heart. The purpose of the study is to see how well SYN2 works in diagnosing CAD compared to other standard methods.

Participants in the study will receive an injection of SYN2 and undergo a PET scan. This scan will help doctors determine if there are any significant blockages in the heart's blood vessels. The study will also involve the use of other medications, such as Adenosine and Regadenoson, which are used to help stress the heart during the imaging process. These medications are given through an infusion, which is a way of delivering medicine directly into the bloodstream.

The study will take place over a short period, with participants attending a few visits to complete the necessary tests and scans. The results from the SYN2 PET scan will be compared to the results from other standard tests to evaluate its effectiveness in diagnosing CAD. Participants will be monitored for any side effects or changes in their health during the study. The goal is to improve the way CAD is diagnosed, potentially leading to better treatment options for patients in the future.

The research process

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

  1. Step 1

    Initial visit and consent

    Upon joining the study, the first step involves attending an initial visit where the informed consent form is signed and dated. This form confirms understanding and agreement to participate in the study.

    During this visit, eligibility is confirmed, ensuring the participant is over 18 years old and scheduled for a coronary angiography to assess coronary artery disease.

  2. Step 2

    Preparation for imaging

    Participants must be capable of undergoing stress imaging protocols, which may involve either pharmacological or exercise stress tests.

    For females of reproductive potential, effective contraception must be used for at least one month prior to screening and continued during the study and for one week after the last administration of the investigational medicinal product (IMP). Males must use effective contraception for three months after the last IMP exposure.

  3. Step 3

    Administration of medications

    The study involves the administration of three medications: SYN2, Adenosine (6 mg/2 ml solution for injection), and Rapiscan (400 microgram solution for injection).

    These medications are administered as solutions for injection, with the specific purpose of aiding in the imaging process to assess coronary artery disease.

  4. Step 4

    Imaging procedure

    Participants undergo a positron emission tomography (PET) scan using the novel tracer SYN2. This imaging technique helps in diagnosing coronary artery disease by evaluating the heart's blood flow.

    The diagnostic performance of the SYN2 PET scan is assessed against a reference standard to determine its effectiveness in detecting significant coronary artery disease.

  5. Step 5

    Monitoring and follow-up

    Throughout the study, participants are monitored for any adverse events, including changes in laboratory parameters, ECG parameters, physical examination, and vital signs.

    The study aims to evaluate the sensitivity and specificity of the SYN2 PET scan in detecting coronary artery disease, with results compared to the reference standard.

Who can join the trial?

8 criteria

  • Provide a signed and dated form that shows you agree to participate in the study.
  • Be willing to follow all the study procedures and be available for the entire study period.
  • Be a male or female who is over 18 years old.
  • Have a scheduled appointment, with written proof, for a procedure called an invasive coronary angiography to check for coronary artery disease (CAD). This is a test that looks at the blood vessels in your heart.
  • Be able to undergo stress imaging tests, which may involve medication or exercise to see how your heart works under stress.
  • If you are a female who can have children, you must use effective birth control for at least one month before the study, during the study, and for one week after the last study medication. Effective methods include using a barrier like a condom or diaphragm, hormonal birth control that stops ovulation (like pills, patches, or injections), or devices placed in the uterus. Not having sex is also allowed if it is your usual lifestyle.
  • If you are a male who can father children, you must use condoms or other effective birth control methods with your partner for three months after the last study medication.
  • Agree to follow the lifestyle guidelines provided during the study.

Who cannot join the trial?

12 criteria

  • People who have been diagnosed with Coronary Artery Disease (CAD) through having a previous heart attack or procedures like opening blocked arteries or heart bypass surgery.
  • Pregnant or breastfeeding women, or women who might be pregnant. Women able to have children must have a negative pregnancy test before certain tests.
  • People with a mental or physical condition that makes them unable to understand and agree to participate in the study.
  • Individuals who are living in an institution due to a legal or administrative order.
  • People who have allergies or are sensitive to SYN2 or similar substances.
  • Individuals who cannot undergo certain heart stress tests, which might involve medication or exercise.
  • People who can't complete all necessary imaging tests, have an illness that might pose a safety risk, or whose participation might interfere with other treatments.
  • People with a history of heart failure, cardiomyopathy, or a low Left Ventricular Ejection Fraction (LVEF), which measures how well the heart pumps blood.
  • Individuals with severe valve disease in the heart.
  • Persons who are going to have heart procedures like balloon angioplasty or bypass surgery within the study period.
  • People being evaluated for or who have already had a heart transplant.
  • Individuals participating in another clinical study within 30 days prior to this study or planning to join another study during the follow-up period.
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Investigated drugs

SYN2 is a novel tracer used in positron emission tomography (PET) imaging. It is designed to help doctors see the heart's blood vessels more clearly in patients who might have coronary artery disease. This tracer is labeled with a special marker that allows it to show up on PET scans, providing detailed images that can help in diagnosing heart conditions.

What is already known about the treatment

SYN2 – This medication is administered as an injection and is used in positron emission tomography (PET) imaging. It is currently being studied in clinical trials for its effectiveness in diagnosing coronary artery disease. The main therapeutic indication is to help detect significant coronary artery disease in patients who are suspected of having this condition. SYN2 works by binding to specific targets in the heart, allowing for clear imaging of blood flow and heart function. It is classified as a diagnostic radiopharmaceutical agent.

Investigated diseases

Coronary Artery Disease – This disease occurs when the major blood vessels that supply the heart with blood, oxygen, and nutrients become damaged or diseased, primarily due to the buildup of cholesterol-containing deposits (plaques) in the coronary arteries. Over time, these plaques can harden or rupture, leading to reduced blood flow to the heart muscle. As the disease progresses, it can cause chest pain (angina), shortness of breath, or other symptoms, especially during physical activity or stress. If a plaque ruptures, it can lead to a heart attack, which is a sudden blockage of blood flow to the heart. The progression of coronary artery disease can vary, with some individuals experiencing symptoms early on, while others may not notice any signs until the disease is advanced. Regular monitoring and lifestyle changes can help manage the condition and slow its progression.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-506971-89-00Protocol codeSAFER3Estimated enrolment290 patients

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

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