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Study on [68Ga]NODAGA-E[c(RGDyK)]2 for Imaging Blood Vessel Growth in Patients with Chronic Ischemic Heart Disease

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 chronic ischemic heart disease, a condition where the heart doesn't receive enough blood due to narrowed or blocked blood vessels. The study will use a special imaging technique called RGD-PET to look at blood vessel growth in the heart. The treatment involves a solution for injection known as [68Ga]NODAGA-E[c(RGDyK)]2, which helps in visualizing the heart's blood vessels.

The purpose of the study is to explore how blood vessel growth in the heart changes before and after a procedure to restore blood flow, known as coronary revascularization. Participants will undergo imaging with RGD-PET both before and after this procedure. The study will also look at how these changes relate to heart function and recovery over time.

Throughout the study, participants will have several imaging sessions to monitor changes in their heart's blood vessels and function. The study aims to provide a better understanding of how the heart heals and adapts after treatment for chronic ischemic heart disease, potentially leading to improved care for patients with this condition.

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 assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age and medical history related to chronic ischemic heart disease.

    Eligibility criteria include being over 50 years old and having a chronic occlusion of coronary arteries, with a clinical referral for either percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG).

  2. Step 2

    First imaging session

    The first imaging session involves a positron emission tomography (PET) scan using the solution for injection called [68Ga]NODAGA-E[c(RGDyK)]2. This scan is designed to measure myocardial angiogenesis, which is the formation of new blood vessels in the heart muscle.

    The injection is administered to visualize the uptake of the tracer in the heart, providing a baseline measurement before any coronary revascularization procedure.

  3. Step 3

    Coronary revascularization procedure

    Participants undergo a coronary revascularization procedure, which may be either PCI or CABG, as clinically indicated.

    This step is crucial for improving blood flow to the heart muscle and is part of the standard treatment for chronic ischemic heart disease.

  4. Step 4

    Second imaging session

    A second PET scan is conducted after the coronary revascularization procedure to measure changes in myocardial angiogenesis.

    This session aims to characterize the difference in tracer uptake before and after the procedure, providing insights into the angiogenic response of the heart.

  5. Step 5

    Follow-up imaging and assessment

    Three weeks after the revascularization, another PET scan is performed to assess the angiogenic response and its correlation with myocardial perfusion and viability.

    Further assessments are conducted 6-8 weeks post-procedure to evaluate functional recovery and the size of any remaining infarct using additional imaging techniques.

Who can join the trial?

5 criteria

  • Participants must be older than 50 years.
  • Participants must be admitted to the Heart Center at Rigshospitalet.
  • Participants must have a condition called chronic occlusion of coronary arteries, which means that the blood vessels supplying the heart are blocked for a long time.
  • Participants must be clinically referred for either PCI or CABG. PCI stands for Percutaneous Coronary Intervention, a procedure to open blocked heart arteries. CABG stands for Coronary Artery Bypass Grafting, a surgery to improve blood flow to the heart.
  • Both male and female participants are eligible.

Who cannot join the trial?

3 criteria

  • Patients who do not have chronic ischemic heart disease cannot participate. This is a condition where the heart doesn't get enough blood and oxygen.
  • Patients who are not within the specified age range cannot participate. The study is for certain age groups only.
  • Patients who are part of a vulnerable population cannot participate. This means people who might need special protection or care.
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Investigated drugs

68Ga-NODAGA-E[c(RGDyK)]2 is a special imaging agent used in PET scans to help visualize blood vessel growth in the heart. This medication is used in patients with chronic ischemic heart disease to see how well new blood vessels are forming in the heart tissue. The imaging helps doctors understand the changes in the heart before and after procedures aimed at improving blood flow.

What is already known about the treatment

68Ga-NODAGA-E[c(RGDyK)]2 – This medication is administered through an intravenous injection and is used in a PET scan to image angiogenesis, which is the formation of new blood vessels, in patients with chronic ischemic heart disease. Currently, it is in the Phase II stage of clinical trials, focusing on its effectiveness in visualizing changes in blood vessel growth before and after coronary revascularization. The main therapeutic indication is to assist in the diagnosis and evaluation of ischemic heart disease by providing detailed images of blood vessel formation. At the molecular level, it works by binding to specific proteins involved in angiogenesis, allowing for clear imaging of these processes. It is classified pharmacologically as a radiopharmaceutical used in diagnostic imaging.

Investigated diseases

Chronic Ischemic Heart Disease – This condition occurs when the heart muscle doesn't receive enough blood and oxygen over a long period, often due to narrowed or blocked coronary arteries. It can lead to chest pain, known as angina, especially during physical activity or stress. Over time, the heart may become weakened, leading to heart failure or irregular heartbeats. The disease progresses slowly, and symptoms may worsen gradually. It is often associated with risk factors like high blood pressure, high cholesterol, smoking, and diabetes. Regular monitoring and lifestyle changes can help manage the condition.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-518640-20-00Estimated enrolment42 patientsSponsorRegion Hovedstaden

sourced from the EU Clinical Trials Register and site verification

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