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Study on O15-Water for Diagnosing Coronary Artery Disease in Patients Using PET Imaging During Stress and Rest Conditions

Verified siteInvestigationalNo placebo
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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 (CAD), a condition where the blood vessels that supply the heart become narrowed or blocked. The study will use a special type of water called O15-Water, which is given through an infusion, to help doctors see how well blood is flowing to the heart. This is done using a technique called Positron Emission Tomography (PET) imaging, which creates detailed pictures of the heart.

The purpose of the study is to confirm how well O15-Water can help identify CAD when the heart is at rest and during stress, which is when the heart is working harder than usual. Participants will receive the O15-Water infusion and undergo PET imaging. The results will be compared to other standard tests that look at the heart's blood vessels, such as an Invasive Coronary Angiogram (ICA) or a Coronary Computed Tomography Angiogram (CCTA).

The study will take place over a period of time, and participants will be monitored to see how well the O15-Water works in detecting significant CAD. The goal is to determine the accuracy of this method in identifying heart disease, which could help improve diagnosis and treatment for patients with CAD 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

    Joining the study

    Upon joining the study, you will have already signed an informed consent form. This confirms your understanding of the study and your agreement to participate.

    You must meet certain criteria, such as being 18 years or older and not being pregnant or lactating if you are a woman of childbearing potential.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to ensure you meet all the necessary criteria for participation. This may include reviewing your medical history and any previous tests related to coronary artery disease.

  3. Step 3

    Medication administration

    You will receive an intravenous administration of 15O-water. This is a solution for infusion, which means it will be delivered directly into your bloodstream through a vein.

    The purpose of this medication is to help identify coronary artery disease during imaging tests.

  4. Step 4

    Imaging tests

    You will undergo a positron emission tomography (PET) scan. This imaging test will help visualize the blood flow in your heart and detect any potential coronary artery disease.

    The PET scan will be conducted under both stress and resting conditions to provide comprehensive results.

  5. Step 5

    Follow-up

    After the imaging tests, there will be a follow-up period to monitor your health and any effects of the study procedures.

    You will be required to use appropriate birth control methods until the end of this follow-up period if you are of childbearing potential.

Who can join the trial?

8 criteria

  • Men and women who are 18 years or older.
  • Must have read, signed, and dated an informed consent form before any study procedures are done. This form explains the study and confirms your agreement to participate.
  • Participants should meet one of the following conditions:
    • Have been referred for an invasive coronary angiogram (ICA), which is a test to look at the heart's blood vessels, either directly or after other non-invasive tests like SPECT or PET MPI, stress echo, CCTA, or ETT.
    • Had an ICA with no treatment done. If any narrowing of the blood vessels between 40% and 70% was seen, a further test called fractional flow reserve (FFR) or instantaneous wave-Free Ratio (iFR) must have been done.
    • Had a coronary computed tomography angiogram (CCTA) showing normal or minimal coronary artery disease (less than 25% narrowing).
    • Women who can have children must not be pregnant or breastfeeding. They must have a negative pregnancy test before starting the study and use appropriate birth control during the study and follow-up period. Women who are surgically sterile or have not had a period for more than a year do not need a pregnancy test.
    • Men must use contraceptive methods until the end of the follow-up period.
    • Participants must be able to follow all study procedures as described in the study plan.

Who cannot join the trial?

3 criteria

  • Patients with a history of **Coronary Artery Disease** cannot participate. This is a condition where the blood vessels that supply blood to the heart are narrowed or blocked.
  • Patients who have undergone an **invasive coronary angiogram (ICA)** with **fractional flow reserve (FFR)** or **instantaneous wave-Free Ratio (iFR)** are excluded. These are tests that measure how well blood is flowing through the coronary arteries.
  • Patients who have had a **coronary computed tomography angiogram (CCTA)** are not eligible. This is a special type of X-ray test that looks at the blood vessels of the heart.
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Investigated drugs

15O-H2O is a special type of water that contains a radioactive form of oxygen. In this clinical trial, it is used to help doctors see how well blood is flowing to the heart. This is done using a special imaging technique called PET, which stands for positron emission tomography. By injecting this water into the bloodstream, doctors can take pictures of the heart and see if there are any areas where blood flow is reduced, which might indicate coronary artery disease. This helps in diagnosing heart problems by comparing the images taken when the heart is at rest and when it is under stress.

What is already known about the treatment

15O-H2O – This medication is administered intravenously and is used in a clinical setting to help diagnose coronary artery disease. It is currently being studied in a Phase 3 clinical trial to confirm its effectiveness in identifying this condition. The main therapeutic use of 15O-H2O is to provide clear images of the heart's blood flow during stress and rest conditions using PET imaging. At the molecular level, it works by emitting positrons that are detected by PET scanners, allowing doctors to see how well blood is flowing to the heart muscle. It is classified as a diagnostic radiopharmaceutical.

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 supply is severely restricted or blocked. Over time, the heart muscle may weaken, leading to heart failure or arrhythmias. The disease progresses gradually and can be influenced by lifestyle factors such as diet, exercise, and smoking.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-503843-33-00Protocol codeMedTrace-002Estimated enrolment238 patientsSponsorMedTrace Pharma A/S

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