Coronary Artery DiseasePhase 3NCT05134012
RAdiolabeled Perfusion to Identify Coronary Artery Disease Using WAter To Evaluate Responses of Myocardial FLOW (RAPID-WATER-FLOW)
A Phase 3 study testing [O-15]-Water PET Myocardial Perfusion Imaging (MPI) in people with Coronary Artery Disease, run by MedTrace Pharma A/S at 13 sites in 6 countries.
Trial summary
This a Phase 3, prospective, open-label, multicenter study of [15-O]-H2O injection for PET imaging of subjects with suspected CAD. Approximately 182 evaluable participants with suspected CAD referred for testing will be included in the study at approximately 10 study sites in the United States and Europe. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- [O-15]-Water PET Myocardial Perfusion Imaging (MPI)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 232 participants
- Where
- 13 sitesin 6 countries
- Study dates
- 8 May 2022to 2 Oct 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female participants ≥18 years;
- Informed consent form (ICF) read, signed, and dated prior to any study procedures being performed;
- Participants who fall into any one of the following categories:
- Have been referred for an ICA directly of after non-invasive testing (e.g., SPECT or PET MPI, stress echo, CCTA, ETT).
- Had an ICA with no intervention. However, if any stenosis >40% but ≤70% was observed, an FFR or iFR assessment was performed.
- Had a CCTA with normal coronaries or minimal CAD (no stenosis >25%).
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- 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.
- 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.
- Male will need to use contraceptive methods until end of the follow-up period.
- Participants are able to comply with all study procedures as described in the protocol.
Who cannot join
- Participants are unable to undergo (even partially) any of the imaging procedures;
- Participants with a known history of cardiac disease including:
- myocardial infarction, previous coronary revascularization, or chronic ischemic cardiomyopathy
- primary myocardial disease such as cardiac amyloidosis or hypertrophic cardiomyopathy
- known left ventricular dysfunction
- moderate or severe aortic or mitral stenosis or regurgitation
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- Participants in whom adenosine stress testing is contraindicated, including but not limited to:
- Participants with severe COPD or chronic asthma.
- Participants with second- or third-degree atrioventricular block without a pacemaker.
- 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).
- 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.
- Participants with significant co-morbidities that would prevent appropriate completion of the protocol procedures.
- 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).
- Participants who have previously participated in this study.
- 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)
Trial locations and contacts
13 sites in 6 countries.
13 sites in 6 countries
United States6 sites
University of Virginia Medical Center
Charlottesville, Virginia, 22903
UT Southwestern Medical Center
Dallas, Texas, 75390
University of Iowa
Iowa City, Iowa, 52242
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Mayo Clinic
Rochester, Minnesota, 55905
Washington University
St Louis, Missouri, 63110
Germany2 sites
University Hospital Freiburg, Clinic for Nuclear Medicine
Freiburg im Breisgau
Department of Cardiology and Angiology -- Hannover Medical School (MHH)
Hanover
Sweden2 sites
Sahlgrenska University Hospital
Gothenburg
Norrland University Hospital Heart Center
Umeå
Netherlands1 site
Amsterdam University Medical Center, Department of Radiology and Nuclear Medicine
Amsterdam, North Holland, 1081HV
About this study
Official title: A Phase 3, Multicenter, Open Label Study to Confirm the Diagnostic Potential of Intravenously Administered [15-O]-H2O to Identify Coronary Artery Disease During Pharmacological Stress and Resting Conditions Using PET Imaging (RAPID-WATER-FLOW)
This a Phase 3, prospective, open-label, multicenter study of [15-O]-H2O injection for PET imaging of subjects with suspected CAD. Approximately 182 evaluable participants with suspected CAD referred for testing will be included in the study at approximately 10 study sites in the United States and Europe. Approximately 215 participants will be enrolled to account for an estimated 15% drop-out rate. Screening assessments will occur prior to enrollment to confirm eligibility. All participants will receive two doses of [15-O]-H2O as part of a single PET imaging session (one dose at rest and one during pharmacological stress with adenosine). A safety follow-up phone call will occur 24 ± 8 hrs after completion of the [15-O]-H2O scan.
- Conditions
- Coronary Artery Disease
- Being tested
- [O-15]-Water PET Myocardial Perfusion Imaging (MPI)
- Keywords
- Myocardial Blood Flow (MBF), Myocardial Perfusion Imaging (MPI), RAPID-WATER-FLOW, Positron Emission Tomography (PET), Oxygen-15, Coronary Artery Disease (CAD)
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[O-15]-Water PET Myocardial Perfusion Imaging (MPI)Drug
[15-O]-H2O injection is a novel PET imaging agent labeled with the radioisotope [15-O] administered as an intravenous (IV) injection. Participants will receive [15-O]-H2O treatment twice as a part of a single day imaging session. All participants will receive two IV boluses of [15-O]-H2O injection in a peripheral vein; one at rest and one during pharmacological stress.
| Study group | Role | What they receive |
|---|---|---|
| [O-15]-Water PET Myocardial Perfusion Imaging (MPI) | Experimental | All participants with suspected CAD will receive two doses of [15-O]-H2O as part of a single PET imaging session (one dose at rest and one during pharmacological stress with adenosine). Receives: Drug: [O-15]-Water PET Myocardial Perfusion Imaging (MPI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of the [15-O]-H2O PET study using the truth-standard of ICA with FFR/iFR or CCTA.
Sensitivity and specificity are defined as follows:
- True Positives (TP): Subjects with abnormal PET MPI and disease positive by the truth standard
- True Negatives (TN): Subjects with normal PET MPI and disease negative by the truth standard
- False Positives (FP): Subjects with abnormal PET MPI and disease negative by the truth standard
- False Negatives (FN): Subjects with normal PET MPI and disease positive by the truth standard
- Sensitivity: TP/(TP + FN)
- Specificity: TN/(TN + FP)
Measured: 30 days
Secondary outcomes (3)
Sensitivity, specificity, and accuracy of [15-O]-H2O PET MPI in participants of special clinical interest (female, BMI≥30, diabetics, multivessel disease).
Sensitivity and specificity are defined as follows:
- True Positives (TP): Subjects with abnormal PET MPI and disease positive by the truth standard
- True Negatives (TN): Subjects with normal PET MPI and disease negative by the truth standard
- False Positives (FP): Subjects with abnormal PET MPI and disease negative by the truth standard
- False Negatives (FN): Subjects with normal PET MPI and disease positive by the truth standard
- Sensitivity: TP/(TP + FN)
- Specificity: TN/(TN + FP)
- Accuracy: (TN + TP)/(TN + TP + FN + FP)
Measured: 30 days
Sensitivity and specificity of 15O-H2O PET in subjects where the standard of truth may use site-determined value of FFR/iFR when the raw FFR/iFR data are not available to the core lab.
Sensitivity and specificity are defined as follows:
- True Positives (TP): Subjects with abnormal PET MPI and disease positive by the truth standard
- True Negatives (TN): Subjects with normal PET MPI and disease negative by the truth standard
- False Positives (FP): Subjects with abnormal PET MPI and disease negative by the truth standard
- False Negatives (FN): Subjects with normal PET MPI and disease positive by the truth standard
- Sensitivity: TP/(TP + FN)
- Specificity: TN/(TN + FP)
- Accuracy: (TN + TP)/(TN + TP + FN + FP)
Measured: 30 days
Adverse event analyses will include tabulations of the incidence (number and percent of subjects) with at least one TEAEs overall and by MedDRA system organ class (SOC) and preferred term (PT). This will be repeated for serious adverse.
Other Safety measures including the following will be summarized descriptively:
- ECG (ventricular heart rate, PR interval, QRS duration, QT interval, QTc interval)
- Vital Signs
- Concomitant Medications
- Protocol Deviations
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start8 May 2022
- Primary completion2 Oct 2026
- Study completion2 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Approximately 182 evaluable participants with suspected CAD referred for testing will be included in the study. All participants will receive two doses of \[15-O\]-H2O as part of a single PET imaging session (one dose at rest and one during pharmacological stress with adenosine).
- Masking
- None (open label)
- Enrolment
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedTrace Pharma A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nicholas Borys, MD, Study director, MedTrace Pharma A/SMarcelo DiCarli, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05134012
- Sponsor's protocol ID
- MedTrace-002
- Status last verified
- Oct 2026
- First submitted
- 29 Oct 2021
- Last updated
- 29 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Di Carli MF, Gormsen LC, Chareonthaitawee P, Johnson GB, Beanlands R, DeKemp R, Schindler T, Gropler R, Kulkarni H, McNeely P, Soman P, Oz O, Zaha V, Sorensen J, Harms H, Orlandi C, Vandenbroucke E, Udelson J. Rationale and design of the RAPID-WATER-FLOW trial: Radiolabeled perfusion to identify coronary artery disease using water to evaluate responses of myocardial FLOW. J Nucl Cardiol. 2024 Jan;31:101779. doi: 10.1016/j.nuclcard.2023.101779. Epub 2023 Dec 5.
PubMed 38215598
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Open Label Study to Confirm the Diagnostic Potential of Intravenously Administered [15-O]-H2O to Identify Coronary Artery Disease During Pharmacological Stress and Resting Conditions Using PET Imaging (RAPID-WATER-FLOW)
- ClinicalTrials.gov ID
- NCT05134012
- Acronym / sponsor ID
- MedTrace-002
- Conditions
- Coronary Artery Disease
- Keywords
- Myocardial Blood Flow (MBF), Myocardial Perfusion Imaging (MPI), RAPID-WATER-FLOW, Positron Emission Tomography (PET), Oxygen-15, Coronary Artery Disease (CAD)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- MedTrace Pharma A/SIndustry (pharma, biotech, devices)
- Study start
- 8 May 2022 (actual)
- Primary completion
- 2 Oct 2026 (actual)
- Study completion
- 2 Oct 2026 (actual)
- First posted
- 24 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This a Phase 3, prospective, open-label, multicenter study of [15-O]-H2O injection for PET imaging of subjects with suspected CAD. Approximately 182 evaluable participants with suspected CAD referred for testing will be included in the study at approximately 10 study sites in the United States and Europe. Approximately 215 participants will be enrolled to account for an estimated 15% drop-out rate. Screening assessments will occur prior to enrollment to confirm eligibility. All participants will receive two doses of [15-O]-H2O as part of a single PET imaging session (one dose at rest and one during pharmacological stress with adenosine). A safety follow-up phone call will occur 24 ± 8 hrs after completion of the [15-O]-H2O scan.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Approximately 182 evaluable participants with suspected CAD referred for testing will be included in the study. All participants will receive two doses of [15-O]-H2O as part of a single PET imaging session (one dose at rest and one during pharmacological stress with adenosine).
| Arm | Type | Receives |
|---|---|---|
| [O-15]-Water PET Myocardial Perfusion Imaging (MPI) | Experimental | Drug: [O-15]-Water PET Myocardial Perfusion Imaging (MPI)All participants with suspected CAD will receive two doses of [15-O]-H2O as part of a single PET imaging session (one dose at rest and one during pharmacological stress with adenosine). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male and female participants ≥18 years;
- Informed consent form (ICF) read, signed, and dated prior to any study procedures being performed;
- Participants who fall into any one of the following categories:
- 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.
- 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.
Key exclusion criteria (15 listed)
- Participants are unable to undergo (even partially) any of the imaging procedures;
- Participants with a known history of cardiac disease including:
- Participants in whom adenosine stress testing is contraindicated, including but not limited to:
- 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).
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [O-15]-Water PET Myocardial Perfusion Imaging (MPI)[15-O]-H2O injection is a novel PET imaging agent labeled with the radioisotope [15-O] administered as an intravenous (IV) injection. Participants will receive [15-O]-H2O treatment twice as a part of a single day imaging session. All participants will receive two IV boluses of [15-O]-H2O injection in a peripheral vein; one at rest and one during pharmacological stress. | Drug | [O-15]-Water PET Myocardial Perfusion Imaging (MPI) |
Primary outcome
Sensitivity and specificity of the [15-O]-H2O PET study using the truth-standard of ICA with FFR/iFR or CCTA.
Time frame: 30 days
Sensitivity and specificity are defined as follows: * True Positives (TP): Subjects with abnormal PET MPI and disease positive by the truth standard * True Negatives (TN): Subjects with normal PET MPI and disease negative by the truth standard * False Positives (FP): Subjects with abnormal PET MPI and disease negative by the truth standard * False Negatives (FN): Subjects with normal PET MPI and disease positive by the truth standard * Sensitivity: TP/(TP + FN) * Specificity: TN/(TN + FP)
3 secondary outcomes
Sensitivity, specificity, and accuracy of [15-O]-H2O PET MPI in participants of special clinical interest (female, BMI≥30, diabetics, multivessel disease).
Time frame: 30 days
Sensitivity and specificity of 15O-H2O PET in subjects where the standard of truth may use site-determined value of FFR/iFR when the raw FFR/iFR data are not available to the core lab.
Time frame: 30 days
Adverse event analyses will include tabulations of the incidence (number and percent of subjects) with at least one TEAEs overall and by MedDRA system organ class (SOC) and preferred term (PT). This will be repeated for serious adverse.
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Derived from this study: PubMed 38215598Di Carli MF, Gormsen LC, Chareonthaitawee P, Johnson GB, Beanlands R, DeKemp R, Schindler T, Gropler R, Kulkarni H, McNeely P, Soman P, Oz O, Zaha V, Sorensen J, Harms H, Orlandi C, Vandenbroucke E, Udelson J. Rationale and design of the RAPID-WATER-FLOW trial: Radiolabeled perfusion to identify coronary artery disease using water to evaluate responses of myocardial FLOW. J Nucl Cardiol. 2024 Jan;31:101779. doi: 10.1016/j.nuclcard.2023.101779. Epub 2023 Dec 5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicholas Borys, MD study director
MedTrace Pharma A/S
Marcelo DiCarli, MD principal investigator
Brigham and Women's Hospital
13 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing [O-15]-Water PET Myocardial Perfusion Imaging (MPI) in people with Coronary Artery Disease, run by MedTrace Pharma A/S at 13 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Germany, Sweden, Canada, Denmark and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of the [15-O]-H2O PET study using the truth-standard of ICA with FFR/iFR or CCTA. (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05134012, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.