Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Radioactive water scan could spot hidden heart disease

NCT ID NCT05134012

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 215 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2022

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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)

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Coronary artery disease are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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

  • Aarhus University Hospital

    Aarhus, Denmark

  • Amsterdam University Medical Center, Department of Radiology and Nuclear Medicine

    Amsterdam, North Holland, 1081HV, Netherlands

  • Department of Cardiology and Angiology -- Hannover Medical School (MHH)

    Hanover, Germany

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Norrland University Hospital Heart Center

    Umeå, Sweden

  • Sahlgrenska University Hospital

    Gothenburg, Sweden

  • UT Southwestern Medical Center

    Dallas, Texas, 75390, United States

  • University Hospital Freiburg, Clinic for Nuclear Medicine

    Freiburg im Breisgau, Germany

  • University of Iowa

    Iowa City, Iowa, 52242, United States

  • University of Ottawa Heart Institute

    Ottawa, Ontario, Canada

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Virginia Medical Center

    Charlottesville, Virginia, 22903, United States

  • Washington University

    St Louis, Missouri, 63110, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.