Myocardial Blood FlowHeart-WaveNCT06356857
Assessing Repeatability and Intra-individual Variability in [O15]H2O-PET Myocardial Perfusion Imaging
An observational study of Myocardial Blood Flow, run by Peter Hovind at 1 site in Denmark.
Trial summary
This study wish to assess the reproducibility of baseline and hyperemic myocardial blood flow as well as myocardial blood flow reserve measurements with [O15]H2O-PET-MPI. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Myocardial Blood Flow
- What is being tested?
- Myocardial perfusion imaging (MPI) using [O15]H2O-PET-CT
- How many people
- 21 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Apr 2024to 17 Mar 2026
- Phase
- Observational
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients > 50 years of age with symptoms suggestive of myocardial ischemia, primarily angina. They have therefore undergone [O15]H2O-PET-MPI by the dept. of cardiology on clinical indication. The investigators will include 50% women.
Who may be able to join
- Patients > 50 years of age referred for [O15]H2O-PET-MPI by the dept. of cardiology on clinical indication with symptoms suggestive of myocardial ischemia, primarily angina.
- Willing to repeat the [O15]H2O-PET-MPI
- Normal left ventricular ejection fraction (EF > 45), as assessed from recent (max 1 year old) echocardiography description in medical journal.
Who cannot join
- Cardiovascular event in between scans (defined as hospitalization for cardiovascular event).
- History of myocardial infarction
- Regional perfusion deficits on the primary [O15]H2O-PET-MPI clinically suspected as a sign of significant coronary stenosis.
- Unstable angina
- Severe Chronic Obstructive Pulmonary Disease (COPD)
- Severe asthma
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- Claustrophobia
- Acute illness
- Significant language barrier, estimated by the investigator not being able to understand the study information sufficiently.
Trial locations and contacts
1 site in 1 country.
About this study
This study wish to assess the reproducibility of baseline and hyperemic myocardial blood flow as well as myocardial blood flow reserve measurements with [O15]H2O-PET-MPI.
Read the detailed description
Myocardial perfusion imaging (MPI) using [O15]H2O-PET-CT represents a validated technique for quantitatively assessing myocardial blood flow (MBF) and myocardial flow reserve (MFR).
With advancements in scanner and software technology, it is now possible to accurately quantify both global and regional MBF in clinical PET-MPI studies. Reduced stress MBF or MFR, as determined by [O15]H2O-PET-MPI, is a reliable indicator for detecting hemodynamically significant coronary artery stenosis. Additionally, MBF and MFR offer valuable prognostic insights into mortality and the risk of myocardial infarction. Clinical experience suggests that implementing [O15]H2O-PET-MPI for coronary artery disease evaluation is not only feasible but also aids in making informed decisions regarding revascularization.
This study wish to assess the reproducibility of baseline and hyperemic myocardial blood flow as well as myocardial blood flow reserve measurements with [O15]H2O-PET-MPI.
- Conditions
- Myocardial Blood Flow
- Being tested
- Myocardial perfusion imaging (MPI) using [O15]H2O-PET-CT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myocardial perfusion imaging (MPI) using [O15]H2O-PET-CTDiagnostic test
Re-scan for comparison with initial scan
| Study group | Role | What they receive |
|---|---|---|
| re-pet participant | Participant are enrolled for a second pet-scan which will be compared with the initial scan. Receives: Diagnostic Test: Myocardial perfusion imaging (MPI) using [O15]H2O-PET-CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
[O15]H2O-PET-MPI variability and repeatability coefficient estimated from 20 patients having [O15]H2O-PET-MPI done twice
In this study two [O15]H2O-PET-CT scans in the same induvidual at two different timepoints will be conducted. This will allow a variability estimation (for each meassurement eg rest MBF (ml/g/min), stress MBF (ml/g/min)) and thereby a calculated repeatability coefficient.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start15 Apr 2024
- Primary completion17 Mar 2025
- Study completion17 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial Blood FlowStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peter Hovind
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Peter Hovind, Bispebjerg Hospital
- Investigators
- Peter Hovind, MD, Phd., Study chair, Bispebjerg hospital, capitol region Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06356857
- Sponsor's protocol ID
- H-23070312
- Acronym
- Heart-Wave
- Status last verified
- May 2026
- First submitted
- 13 Mar 2024
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Repeatability and Intra-individual Variability in [O15]H2O-PET Myocardial Perfusion Imaging
- ClinicalTrials.gov ID
- NCT06356857
- Acronym / sponsor ID
- Heart-Wave / H-23070312
- Conditions
- Myocardial Blood Flow
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Peter HovindUniversity, hospital or other
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 17 Mar 2025 (actual)
- Study completion
- 17 Mar 2026 (actual)
- First posted
- 10 Apr 2024 (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 study wish to assess the reproducibility of baseline and hyperemic myocardial blood flow as well as myocardial blood flow reserve measurements with [O15]H2O-PET-MPI.
Detailed description
Myocardial perfusion imaging (MPI) using [O15]H2O-PET-CT represents a validated technique for quantitatively assessing myocardial blood flow (MBF) and myocardial flow reserve (MFR).
With advancements in scanner and software technology, it is now possible to accurately quantify both global and regional MBF in clinical PET-MPI studies. Reduced stress MBF or MFR, as determined by [O15]H2O-PET-MPI, is a reliable indicator for detecting hemodynamically significant coronary artery stenosis. Additionally, MBF and MFR offer valuable prognostic insights into mortality and the risk of myocardial infarction. Clinical experience suggests that implementing [O15]H2O-PET-MPI for coronary artery disease evaluation is not only feasible but also aids in making informed decisions regarding revascularization.
This study wish to assess the reproducibility of baseline and hyperemic myocardial blood flow as well as myocardial blood flow reserve measurements with [O15]H2O-PET-MPI.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| re-pet participant | – | Diagnostic Test: Myocardial perfusion imaging (MPI) using [O15]H2O-PET-CTParticipant are enrolled for a second pet-scan which will be compared with the initial scan. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients > 50 years of age with symptoms suggestive of myocardial ischemia, primarily angina. They have therefore undergone [O15]H2O-PET-MPI by the dept. of cardiology on clinical indication. The investigators will include 50% women.
Key inclusion criteria (3 listed)
- Patients > 50 years of age referred for [O15]H2O-PET-MPI by the dept. of cardiology on clinical indication with symptoms suggestive of myocardial ischemia, primarily angina.
- Willing to repeat the [O15]H2O-PET-MPI
- Normal left ventricular ejection fraction (EF > 45), as assessed from recent (max 1 year old) echocardiography description in medical journal.
Key exclusion criteria (9 listed)
- Cardiovascular event in between scans (defined as hospitalization for cardiovascular event).
- History of myocardial infarction
- Regional perfusion deficits on the primary [O15]H2O-PET-MPI clinically suspected as a sign of significant coronary stenosis.
- Unstable angina
- Severe Chronic Obstructive Pulmonary Disease (COPD)
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 |
|---|---|---|
| Myocardial perfusion imaging (MPI) using [O15]H2O-PET-CTRe-scan for comparison with initial scan | Diagnostic test | re-pet participant |
Primary outcome
[O15]H2O-PET-MPI variability and repeatability coefficient estimated from 20 patients having [O15]H2O-PET-MPI done twice
Time frame: 8 months
In this study two [O15]H2O-PET-CT scans in the same induvidual at two different timepoints will be conducted. This will allow a variability estimation (for each meassurement eg rest MBF (ml/g/min), stress MBF (ml/g/min)) and thereby a calculated repeatability coefficient.
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 15 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Peter Hovind, MD, Phd. study chair
Bispebjerg hospital, capitol region Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Blood Flow, run by Peter Hovind at 1 site in Denmark.
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 3 inclusion and 9 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 15 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 1 site in Denmark. 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.
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?
[O15]H2O-PET-MPI variability and repeatability coefficient estimated from 20 patients having [O15]H2O-PET-MPI done twice (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Oct 2026.