Radioactive water scan could spot hidden heart disease
NCT ID NCT05134012
First seen Jun 25, 2026 · Last updated Aug 11, 2026 · Updated 4 times
Summary
This phase 3 trial is testing whether a special PET scan using radioactive water ([15-O]-H2O) can accurately detect coronary artery disease. About 215 adults with suspected heart disease will receive the injection at rest and during stress, then compare results to standard tests. The goal is to confirm if this imaging method is a reliable, non-invasive diagnostic tool.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- [15-O]-H2O (radioactive water) injection
- What this could lead to
- If successful, this could provide a more accurate, non-invasive way to diagnose coronary artery disease, potentially reducing the need for invasive procedures.
- What could go wrong
- This is a diagnostic trial, not a treatment. The test may not prove accurate enough in all patient groups, and results may not change patient outcomes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 215 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2022
- Expected to finish
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Oct 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Male and female participants ≥18 years; 2. Informed consent form (ICF) read, signed, and dated prior to any study procedures being performed; 3. Participants who fall into any one of the following categories: 1. Have been referred for an ICA directly of after non-invasive testing (e.g., SPECT or PET MPI, stress echo, CCTA, ETT). 2. Had an ICA with no intervention. However, if any stenosis \>40% but ≤70% was observed, an FFR or iFR assessment was performed. 3. Had a CCTA with normal coronaries or minimal CAD (no stenosis \>25%). The SPECT study, PET 15O-H2O study, and ICA or CCTA testing need to be completed within a 30-day window, with time 0 defined as the date of the first of these three tests. 4. Women of Child Bearing Potential (WOCBP) must be non-pregnant, and non-lactating. For women of childbearing potential, the results of a urine human chorionic gonadotropin (HCG) pregnancy test (with the result known on the day of drug administration) must be negative; these participants must be practicing appropriate birth control from time of the screening visit until the end of the follow-up period. For women who are either surgically sterile (have a documented bilateral tubal ligation or oophorectomy and/or hysterectomy) or are post-menopausal (cessation of menses for more than 1 year), enrollment in the study without a pregnancy test at screening is allowed. 5. Male will need to use contraceptive methods until end of the follow-up period. 6. Participants are able to comply with all study procedures as described in the protocol. Exclusion Criteria: 1. Participants are unable to undergo (even partially) any of the imaging procedures; 2. Participants with a known history of cardiac disease including: 1. myocardial infarction, previous coronary revascularization, or chronic ischemic cardiomyopathy 2. primary myocardial disease such as cardiac amyloidosis or hypertrophic cardiomyopathy 3. known left ventricular dysfunction 4. moderate or severe aortic or mitral stenosis or regurgitation 3. Participants in whom adenosine stress testing is contraindicated, including but not limited to: 1. Participants with severe COPD or chronic asthma. 2. Participants with second- or third-degree atrioventricular block without a pacemaker. 4. Participants with claustrophobia to an extent that would limit their ability to undergo SPECT and PET imaging (patients whose claustrophobia is known to be readily controlled with drugs or psychological support may be enrolled). 5. Participants who are on sildenafil (Viagra) or oral dipyridamole (Persantine, Aggrenox) therapy or on any PDE5 inhibitor (i.e. tadalafil, avanafil, vardenafil),and for whom its use cannot be terminated or suspended for ≥24 hours prior to treatment of study drug. 6. Participants with significant co-morbidities that would prevent appropriate completion of the protocol procedures. 7. Participants who have participated in another research study using investigational drugs within the 30 days prior to enrollment or through the duration of the trial (patients in observational studies with approved agents and participants known to be on placebo may be enrolled). 8. Participants who have previously participated in this study. 9. Subjects scheduled for, or planning to undergo, any interventional cardiac procedures between enrollment and ICA (pathway 1) or signing of informed consent and 15O-H2O PET MPI (pathway 2 and 3)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Aarhus University Hospital
Aarhus, Denmark
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Amsterdam University Medical Center, Department of Radiology and Nuclear Medicine
Amsterdam, North Holland, 1081HV, Netherlands
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Department of Cardiology and Angiology -- Hannover Medical School (MHH)
Hanover, Germany
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Mayo Clinic
Rochester, Minnesota, 55905, United States
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Norrland University Hospital Heart Center
Umeå, Sweden
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Sahlgrenska University Hospital
Gothenburg, Sweden
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UT Southwestern Medical Center
Dallas, Texas, 75390, United States
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University Hospital Freiburg, Clinic for Nuclear Medicine
Freiburg im Breisgau, Germany
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University of Iowa
Iowa City, Iowa, 52242, United States
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University of Ottawa Heart Institute
Ottawa, Ontario, Canada
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University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
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University of Virginia Medical Center
Charlottesville, Virginia, 22903, United States
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Washington University
St Louis, Missouri, 63110, United States
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