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Prognostic H2[15O] PET Imaging Study in Patients with Coronary Artery Disease Using O15‑Water, Adenosine and Regadenoson

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What is this trial about?

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

The study focuses on people who have or are suspected of having Coronary Artery Disease, a condition where the arteries that supply blood to the heart become narrowed or blocked. To look at how well blood is reaching the heart muscle, a special imaging test called positron emission tomography is used. This scan measures the amount of blood flow in the heart at rest and during a brief period of increased activity.

During the scan, a short‑acting medicine is given through an IV to make the heart work a little harder, allowing doctors to see how the blood vessels respond. The medicines used are Adenosine and regadenoson, both of which safely cause a temporary rise in heart workload. A small amount of a harmless radioactive substance, O15-water, is also injected so the scanner can create detailed pictures of blood flow. The amount of blood moving through the heart muscle is expressed as MBF, which helps identify areas that may not be getting enough oxygen.

The purpose of the study is to find specific numbers that can predict the chance of future major heart problems, known as MACE. Participants undergo the PET scan with the stress medicines, then are followed for several years while information about any heart attacks, deaths, or related events is recorded. This follow‑up helps determine which scan results are linked to higher or lower risk.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Enrollment confirmation and scheduling
After joining the study, a study identification number is assigned and the first imaging appointment is scheduled.
Step 2
Pre‑scan preparation
Arrive at the imaging center on the scheduled day.
Confirm that you have fasted for at least four hours and have avoided caffeine.
An intravenous (iv) line is placed in a vein for medication and tracer administration.
Step 3
Resting pet scan with o15‑water
A small amount of o15-water (800 mbq) is injected through the iv line.
The pet scanner records blood flow in the heart while you are at rest.
Step 4
Pharmacological stress administration
You receive a stress‑inducing medication to widen the coronary vessels.
The medication is either adenosine given as an iv infusion at a dose of 140 µg per kilogram of body weight, administered continuously for about six minutes, or a single iv bolus of regadenoson 400 µg.
Both drugs have a short duration of action and are used only for the scan.
Step 5
Stress pet scan with o15‑water
While the stress medication is active, a second dose of o15-water (800 mbq) is injected.
The pet scanner records blood flow in the heart under stress conditions.
Step 6
Post‑scan monitoring
After the scan, vital signs such as blood pressure and heart rate are checked.
You are observed for approximately thirty minutes for any side effects of the medication.
Step 7
Discharge and instructions
You receive written instructions about activity, fluid intake, and avoidance of caffeine for a short period.
You may then leave the imaging center and resume normal daily activities.
Step 8
Long‑term follow‑up
You will be asked to provide health information at scheduled follow‑up points, typically at 2 years, 5 years, and up to 10 years after the scan.
These follow‑up visits are used to record any major adverse cardiovascular events such as heart attacks or death.

Who can join the trial?

15 criteria

Signed written consent is required.
You must be 18 years of age or older.
You must have coronary artery disease (CAD) that is either suspected by your doctor or already diagnosed.
Your doctor must think you need myocardial perfusion imaging (MPI) based on current medical guidelines.
If you belong to a special group (A‑J), you must also meet the specific rule for that group.
Group A – anti‑anginal treatment: high chance of CAD, chest pain (called angina) is the main symptom, you are not on strong anti‑anginal medicine or can stop it for a short time, and you have never had a coronary procedure.
Group B – heart‑failure treatment: newly diagnosed “idiopathic dilated cardiomyopathy” (the heart’s main pumping chamber is enlarged and weak without a known cause) and you are not yet on heart‑failure medication or have just started it.
Group C – TAVI: severe “aortic stenosis” (narrowing of the valve that lets blood leave the heart) and you are planned to receive a “transcatheter aortic valve implantation (TAVI)”.
Group D – CTO: have a blocked coronary artery called “chronic total occlusion (CTO)” and you are suitable for either medication alone, a procedure called “percutaneous coronary intervention (PCI)”, or a special “reducer stent”.
Group E – anti‑inflammatory treatment: have “cardiac sarcoidosis” (an inflammatory disease of the heart) and need anti‑inflammatory medication.
Group F – CKD: have chronic kidney disease (CKD) with an estimated glomerular filtration rate (eGFR) below 60 ml/min/1.73 m² and you are not on regular dialysis.
Group G – long‑term dialysis: are already receiving regular dialysis because of end‑stage kidney disease.
Group H – kidney transplantation: have end‑stage kidney disease and are being evaluated for a kidney transplant.
Group I – Takotsubo syndrome: have a temporary heart condition called “Takotsubo syndrome” that is stable and not causing low blood pressure.
Group J – STEMI: recently had a heart attack called “ST‑segment elevation myocardial infarction (STEMI)” that was treated with a procedure to open the artery.

Who cannot join the trial?

4 criteria

If a doctor has told you that the medicines used to stress your heart (called pharmacological stress agents) are not safe for you, you cannot join the study.
If you cannot have the imaging tests (called PET/CT or PET/MR) because you are extremely afraid of small spaces (claustrophobia) or you have medical devices that are not safe for MRI scans (non‑MR‑conditional implants), you are excluded.
If you are unable to understand the study instructions or cannot follow the required preparations and procedures, you cannot participate.
If you are pregnant, may become pregnant, or are breastfeeding (lactation), you are not allowed to take part. Women who could become pregnant must have a negative urine or blood pregnancy test before every scan.

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Queen Silvia Childrens Hospital - Sahlgrenska University Hospital - Vaestra Goetalandsregionen
Gothenburg, Sweden

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Investigated drugs

Adenosine
is a medication given through an IV line that temporarily widens the blood vessels in the heart. In this trial it is used to create a “stress” condition for the heart during PET scanning, allowing doctors to see how well blood flows through the heart muscle when it is working harder.
Regadenoson
is another IV medication that also causes the heart’s blood vessels to open up, producing a stress effect similar to exercise. It is used in the study as an alternative way to stress the heart during the PET scan, helping to compare how the heart’s blood flow responds under different stress agents.
O15‑water
is a special radioactive water solution that is injected into a vein and then taken up by the heart. The PET scanner detects the tiny amount of radiation from this tracer, creating images that show the exact amount of blood flowing through the heart muscle at rest and during the stress caused by the medications. This information is used to predict the risk of future heart problems.

What is already known about the treatment

Adenosine
This medication is given as an intravenous infusion of a sterile solution for injection. It is an approved and widely used drug in cardiac imaging and for treating certain rapid heart rhythms. Adenosine works by binding to adenosine receptors in the heart and blood vessels, which widens the coronary arteries and slows the heart’s electrical signals. It is classified as an endogenous nucleoside and a vasodilator/anti‑arrhythmic agent.
Regadenoson
This drug is administered as a single intravenous injection of a clear solution. It is an FDA‑approved stress agent used mainly for myocardial perfusion imaging to evaluate coronary artery disease. Regadenoson selectively activates the A2A adenosine receptors, causing the coronary vessels to relax and increase blood flow without major effects on heart rate. It belongs to the class of selective adenosine A2A receptor agonists and is used as a vasodilator for cardiac stress testing.

Investigated diseases

Cardiovascular disease - Cardiovascular disease refers to conditions that affect the heart and blood vessels. It often starts with the gradual buildup of material inside artery walls, which narrows the vessels over time. The narrowing can lower blood flow, causing discomfort or tiredness during physical activity. As the condition progresses, the heart may have to pump harder, leading to enlargement or reduced pumping efficiency. Continued restriction of blood flow can result in damage to heart muscle or other organs.