Ischemic Heart DiseasePREFERNCT04940247
Myocardial Perfusion Imaging by Combined 15O-H2O PET and MR
An observational study of Ischemic Heart Disease, run by University of Aarhus at 1 site in Denmark.
Trial summary
The trial will include 75 patients with evident or suspected ischemic heart disease refered to Department of Nuclear Medicine \& PET Centre, Aarhus University Hospital, for perfusion imaging by 15O-H2O PET/CT scan of the heart during rest and stress. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Heart Disease
- How many people
- 73 participants
- Where
- 1 siteDenmark
- Study dates
- 8 Feb 2021to 1 Nov 2022
- How long will I take part?
- 10 Years
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any patient with known or suspected ischemic heart disease referred for a clinical H2O-PET at Department of Nuclear Medicine and PET Centre, Aarhus University Hospital, not meeting any exclusion criteria will be enrolled in the study.
Who may be able to join
- Refered for myocardial perfusion imaging by O15-H2O PET at Department of Nuclear Medicine \& PET Centre, Aarhus University Hospital
- > 18 years of age
Who cannot join
- Allergic to adenosine
- Allergic to gadolinium
- Pregnancy
- Claustrophobia
- Severe Asthma
- Pacemaker or other ferro-magnetic implants
- GFR < 30
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Myocardial Perfusion Imaging by Combined 15O-H2O PET and MR for Evaluation of Reversible Myocardial Ischemia
The trial will include 75 patients with evident or suspected ischemic heart disease refered to Department of Nuclear Medicine \& PET Centre, Aarhus University Hospital, for perfusion imaging by 15O-H2O PET/CT scan of the heart during rest and stress. Instead of the clinical scan participants will undergo perfusion imaging by 15O-H2O PET/MR.
The clinician will receive diagnostic information based on the 15O-H2O PET scan as if the patient had not participated in the study. As such, the study has no influence on the diagnostics or treatments of the patient.
Read more
Data from the scans will be used to compare 15O-H2O PET with cardiac MR for evaluation of myocardial perfusion.
Follow up will be done for up to 10 years in regards to major cardiovascular events in order to determine the prognostic value of the scan.
- Conditions
- Ischemic Heart Disease
- Keywords
- Myocardial perfusion imaging, Positron-Emission Tomography, Cardiac Magnetic Resonance Imaging, Coronary Artery Disease, Coronary Flow Reserve, Myocardial Blood Flow
- Medical subject headings
- Myocardial Ischemia, Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in myocardial blood flow
The difference in assessed myocardial blood flow as measured by 15O-H2O PET and MR
Measured: 2 years
Prognostic value within 10 years
Number of participants who experience a major adverse cardiac event within 10 years of follow-up.
Measured: 10 years
Secondary outcomes (11)
Difference in coronary flow reserve
The difference in assessed myocardial blood flow as measured by 15O-H2O PET and MR
Measured: 2 Years
Difference in predictive value
The difference in predictive value of myocardial blood flow measurements as measured by 15O-H2O PET and MR
Measured: 10 years
Difference in left ventricular end-systolic volume
The difference in left ventricular end-systolic volume as measured by 15O-H2O PET and MR
Measured: 2 years
Difference in left ventricular end-diastolic volume
The difference in left ventricular end-diastolic volume as measured by 15O-H2O PET and MR
Measured: 2 years
Difference in right ventricular end-systolic volume
The difference in right ventricular end-systolic volume as measured by 15O-H2O PET and MR
Measured: 2 years
Difference in right ventricular end-diastolic volume
The difference in right ventricular end-diastolic volume as measured by 15O-H2O PET and MR
Measured: 2 years
Difference in left ventricular mass
The difference in left ventricular mass as measured by 15O-H2O PET and MR
Measured: 2 years
Amount of scar tissue
Scar tissue assessment as measured by MR
Measured: 2 years
Pulmonary transit time
Pulmonary transit time as measured by 15O-H2O PET
Measured: 2 years
Pulmonary perfusion
Pulmonary perfusion as measured by 15O-H2O PET
Measured: 2 years
Prognostic value within 3,5 years
Number of participants who experience a major adverse cardiac event within 3,5 years of follow-up.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2021
- Study start8 Feb 2021
- Primary completion1 Nov 2022
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 73 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04940247
- Sponsor's protocol ID
- PREFER
- Acronym
- PREFER
- Status last verified
- Dec 2022
- First submitted
- 9 Jun 2021
- Last updated
- 23 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myocardial Perfusion Imaging by Combined 15O-H2O PET and MR for Evaluation of Reversible Myocardial Ischemia
- ClinicalTrials.gov ID
- NCT04940247
- Acronym / sponsor ID
- PREFER / PREFER
- Conditions
- Ischemic Heart Disease
- Keywords
- Myocardial perfusion imaging, Positron-Emission Tomography, Cardiac Magnetic Resonance Imaging, Coronary Artery Disease, Coronary Flow Reserve, Myocardial Blood Flow
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 8 Feb 2021 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 25 Jun 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.
The trial will include 75 patients with evident or suspected ischemic heart disease refered to Department of Nuclear Medicine \& PET Centre, Aarhus University Hospital, for perfusion imaging by 15O-H2O PET/CT scan of the heart during rest and stress. Instead of the clinical scan participants will undergo perfusion imaging by 15O-H2O PET/MR.
The clinician will receive diagnostic information based on the 15O-H2O PET scan as if the patient had not participated in the study. As such, the study has no influence on the diagnostics or treatments of the patient.
Data from the scans will be used to compare 15O-H2O PET with cardiac MR for evaluation of myocardial perfusion.
Follow up will be done for up to 10 years in regards to major cardiovascular events in order to determine the prognostic value of the scan.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any patient with known or suspected ischemic heart disease referred for a clinical H2O-PET at Department of Nuclear Medicine and PET Centre, Aarhus University Hospital, not meeting any exclusion criteria will be enrolled in the study.
Key inclusion criteria (2 listed)
- Refered for myocardial perfusion imaging by O15-H2O PET at Department of Nuclear Medicine \& PET Centre, Aarhus University Hospital
- > 18 years of age
Key exclusion criteria (7 listed)
- Allergic to adenosine
- Allergic to gadolinium
- Pregnancy
- Claustrophobia
- Severe Asthma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Difference in myocardial blood flow
Time frame: 2 years
The difference in assessed myocardial blood flow as measured by 15O-H2O PET and MR
Prognostic value within 10 years
Time frame: 10 years
Number of participants who experience a major adverse cardiac event within 10 years of follow-up.
11 secondary outcomes
Difference in coronary flow reserve
Time frame: 2 Years
Difference in predictive value
Time frame: 10 years
Difference in left ventricular end-systolic volume
Time frame: 2 years
Difference in left ventricular end-diastolic volume
Time frame: 2 years
Difference in right ventricular end-systolic volume
Time frame: 2 years
Difference in right ventricular end-diastolic volume
Time frame: 2 years
Difference in left ventricular mass
Time frame: 2 years
Amount of scar tissue
Time frame: 2 years
Pulmonary transit time
Time frame: 2 years
Pulmonary perfusion
Time frame: 2 years
Prognostic value within 3,5 years
Time frame: 5 years
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 23 Dec 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Ischemic Heart Disease, run by University of Aarhus 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 2 inclusion and 7 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 23 Dec 2022. 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?
Difference in myocardial blood flow (time frame: 2 years). The study lists 2 primary outcomes in all. 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 23 Dec 2022.