Ischemic Heart DiseaseNCT04451551
Myocardial Perfusion Imaging by 15O-H2O PET/CT
An observational study of Ischemic Heart Disease, run by University of Aarhus at 1 site in Denmark.
Trial summary
The trial will include 5000 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. The patients will undergo the clinical scan as normal. 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
- 5,000 participants
- Where
- 1 siteDenmark
- Study dates
- 23 Jun 2020to 1 Aug 2036
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Known or suspected ischemic heart disease referred for a clinical H2O-PET at Department of Nuclear Medicine and PET Centre, Aarhus University Hospital
Who cannot join
- Claustrophobia, severe asthma, younger than 18 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Aarhus University Hospital
Aarhus, Aarhus N, 8200
Simon Madsen, simmas@rm.dk
About this study
Official title: Myocardial Perfusion Imaging by 15O-H2O PET/CT: Reference Values and Prognostic Value
The trial will include 5000 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. The patients will undergo the clinical scan as normal.
Data from the scans will be used to determine reference values of the examination.
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, Coronary Artery Disease, Coronary Flow Reserve, Myocardial Blood Flow, Prognosis, Reference Value
- 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.
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 (13)
Myocardial blood flow
The myocardial blood flow of participants assessed by 15O-H2O PET/CT
Measured: 5 Years
Coronary flow reserve
The coronary flow reserve of participants assessed by 15O-H2O PET/CT
Measured: 5 Years
Pulmonary transit time
The pulmonary transit time of participants assessed by 15O-H2O PET/CT
Measured: 5 Years
Left ventricular end-systolic volume
The left ventricular end-systolic volume of participants assessed by 15O-H2O PET/CT
Measured: 5 Years
Left ventricular end-diastolic volume
The left ventricular end-diastolic volume of participants assessed by 15O-H2O PET/CT
Measured: 5 Years
Right ventricular end-systolic volume
The right ventricular end-systolic volume of participants assessed by 15O-H2O PET/CT
Measured: 5 Years
Right ventricular end-diastolic volume
The right ventricular end-diastolic volume of participants assessed by 15O-H2O PET/CT
Measured: 5 Years
Immediate coronary angiography followup
Number of participants who undergo coronary angiography within 3 months after primary 15O-H2O PET/CT
Measured: 5 years
Immediate percutaneous coronary intervention (PCI) followup
Number of participants who undergo percutaneous coronary intervention within 3 months after primary 15O-H2O PET/CT
Measured: 5 years
Immediate coronary artery bypass graft (CABG) followup
Number of participants who undergo coronary artery bypass graft within 3 months after primary 15O-H2O PET/CT
Measured: 5 years
Prognostic value within 5 years
Number of participants who experience a major adverse cardiac event within 5 years of follow-up.
Measured: 5 years
Prognostic value within 2 years
Number of participants who experience a major adverse cardiac event within 2 years of follow-up.
Measured: 2 years
Prognostic value within 1 years
Number of participants who experience a major adverse cardiac event within 1 years of follow-up.
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2020
- Study start23 Jun 2020
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Aug 2036 (estimated)
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
- 5,000 participants (estimated)
- 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
- NCT04451551
- Sponsor's protocol ID
- 15O-H2O PET Cohort
- Status last verified
- Jan 2023
- First submitted
- 23 Jun 2020
- Last updated
- 24 Jan 2024
- 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 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myocardial Perfusion Imaging by 15O-H2O PET/CT: Reference Values and Prognostic Value
- ClinicalTrials.gov ID
- NCT04451551
- Acronym / sponsor ID
- 15O-H2O PET Cohort
- Conditions
- Ischemic Heart Disease
- Keywords
- Myocardial Perfusion Imaging, Positron-Emission Tomography, Coronary Artery Disease, Coronary Flow Reserve, Myocardial Blood Flow, Prognosis, Reference Value
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 23 Jun 2020 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Aug 2036 (estimated)
- First posted
- 30 Jun 2020 (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 5000 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. The patients will undergo the clinical scan as normal.
Data from the scans will be used to determine reference values of the examination.
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 (1 listed)
- Known or suspected ischemic heart disease referred for a clinical H2O-PET at Department of Nuclear Medicine and PET Centre, Aarhus University Hospital
Key exclusion criteria (1 listed)
- Claustrophobia, severe asthma, younger than 18 years
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
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.
13 secondary outcomes
Myocardial blood flow
Time frame: 5 Years
Coronary flow reserve
Time frame: 5 Years
Pulmonary transit time
Time frame: 5 Years
Left ventricular end-systolic volume
Time frame: 5 Years
Left ventricular end-diastolic volume
Time frame: 5 Years
Right ventricular end-systolic volume
Time frame: 5 Years
Right ventricular end-diastolic volume
Time frame: 5 Years
Immediate coronary angiography followup
Time frame: 5 years
Immediate percutaneous coronary intervention (PCI) followup
Time frame: 5 years
Immediate coronary artery bypass graft (CABG) followup
Time frame: 5 years
Prognostic value within 5 years
Time frame: 5 years
Prognostic value within 2 years
Time frame: 2 years
Prognostic value within 1 years
Time frame: 1 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
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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.
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 24 Jan 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Simon Madsen, MD (4520140596+, simmas@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prognostic value within 10 years (time frame: 10 years). 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 24 Jan 2024.