Myocardial Perfusion ImagingULYSSESNCT03917199
Utility of Regadenoson Low-dose Dynamic Computed Tomography for Myocardial Perfusion Assesment (ULYSSES Study).
An observational study of Myocardial Perfusion Imaging and Computed Tomography, run by National Institute of Cardiology, Warsaw, Poland at 1 site in Poland.
Trial summary
The ULYSSES study is a single-center, prospective study aimed at evaluation of myocardial ischemia using regadenoson low-dose dynamic computed tomography myocardial perfusion imaging (CTP) in patients diagnosed with intermediate coronary artery stenoses in referrence to the magnetic resonance myocardial perfusion… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Perfusion Imaging, Computed Tomography, Coronary Artery Disease
- How many people
- 60 participants
- Where
- 1 sitePoland
- Study dates
- Nov 2016to 11 Jul 2019
- 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: Study population as described in inclusion and exclusion criteria.
Who may be able to join
- age over 18 years
- signing written, informed consent by the patient for participation in the study
- patients who are asymptomatic or with symptoms of stable coronary heart disease
- intermediate coronary artery stenosis of at least one coronary artery in CTCA
Who cannot join
- the symptoms of unstable ischemic heart disease and /or myocardial infarction,
- the history of myocardial infarction
- patients with impaired renal function (GFR <60 mL)
- contraindications for computed tomography or magnetic resonance imaging (including pregnancy, the presence of a cardiac pacemaker or cardioverter-defibrillator, claustrophobia, the presence of metal elements, etc.);
- contraindications to the administration of iodine contrast media (including allergy to contrast, unstable hyperthyroidism, etc.)
- contraindications to administration of regadenosone (hypersensitivity to the active substance, second or third degree atrioventricular block or other sinus node dysfunction, unstable angina, hypotension, decompensated heart failure, etc.);
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- heart failure with impaired left ventricular systolic function
- a significant valvular heart disease
- presence of aortic aneurysm or aortic dissection
- persistent atrial fibrillation / atrial flutter
- hypertrophic cardiomyopathy
Trial locations and contacts
1 site in 1 country.
About this study
The ULYSSES study is a single-center, prospective study aimed at evaluation of myocardial ischemia using regadenoson low-dose dynamic computed tomography myocardial perfusion imaging (CTP) in patients diagnosed with intermediate coronary artery stenoses in referrence to the magnetic resonance myocardial perfusion imaging (MR MPI).
Read the detailed description
The ULYSSES study is a single-center, prospective study aimed at evaluation of myocardial ischemia using regadenoson low-dose dynamic computed tomography myocardial perfusion (CTP) in patients diagnosed with intermediate coronary artery stenoses in referrence to the magnetic resonance myocardial perfusion imaging (MR MPI).
The main objectives of the study are:
- to evaluate feasibility of low - dose regadenoson dynamic computed tomography myocardial imaging protocol
- to assess the diagnostic value of quantitative dynamic CTP based absolute parameters (myocardial blood flow - MBF, myocardial blood volume - MBV, perfused capillary blood volume - PCBV, peak value - PV, time to peak - TTP) in reference to magnetic resonance myocardial perfusion imaging
- to assess the diagnostic value of quantitative dynamic CTP based relative parameters (relative myocardial blood flow - MBFR, relative myocardial blood volume - MBVR, relative perfused capillary blood volume - PCBVR, relative peak value - PVR, relative time to peak - TTPR) in reference to magnetic resonance myocardial perfusion imaging
- evaluation of safety of regadenoson low-dose dynamic CTP.
- Keywords
- myocardial perfusion imaging, computed tomography perfusion, regadenoson, dynamic perfusion, coronary artery disease
- Medical subject headings
- Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of feasibility of regadenoson low - dose dynamic computed tomography perfusion protocol.
Evaluation of the quality of CTP images asessed by experienced readers.
Measured: 24 months
Assessment of ischemia in regadenoson low-dose dynamic CTP in reference to magnetic resonance myocardial perfusion imaging (MR MPI).
The presence of ischemia in CTP per myocardial segment.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study startNov 2016
- Primary completionJul 2019
- Study completion11 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial Perfusion ImagingStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Cardiology, Warsaw, Poland
- Sponsor type
- University, hospital or other
- Collaborators
- National Science Centre, Poland
- Responsible party
- Sponsor
- Investigators
- Cezary Kepka, MD, PhD, Principal investigator, Institute of Cardiology, warsaw, PL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03917199
- Sponsor's protocol ID
- 2015/19/B/NZ5/03502
- Acronym
- ULYSSES
- Status last verified
- Sep 2019
- First submitted
- 2 Mar 2017
- Last updated
- 17 Sep 2019
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of Regadenoson Low-dose Dynamic Computed Tomography for Myocardial Perfusion Assesment (ULYSSES Study).
- ClinicalTrials.gov ID
- NCT03917199
- Acronym / sponsor ID
- ULYSSES / 2015/19/B/NZ5/03502
- Keywords
- myocardial perfusion imaging, computed tomography perfusion, regadenoson, dynamic perfusion, coronary artery disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- National Institute of Cardiology, Warsaw, PolandUniversity, hospital or other
- Collaborators
- National Science Centre, Poland
- Study start
- Nov 2016
- Primary completion
- Jul 2019 (actual)
- Study completion
- 11 Jul 2019 (actual)
- First posted
- 16 Apr 2019 (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 ULYSSES study is a single-center, prospective study aimed at evaluation of myocardial ischemia using regadenoson low-dose dynamic computed tomography myocardial perfusion imaging (CTP) in patients diagnosed with intermediate coronary artery stenoses in referrence to the magnetic resonance myocardial perfusion imaging (MR MPI).
Detailed description
The ULYSSES study is a single-center, prospective study aimed at evaluation of myocardial ischemia using regadenoson low-dose dynamic computed tomography myocardial perfusion (CTP) in patients diagnosed with intermediate coronary artery stenoses in referrence to the magnetic resonance myocardial perfusion imaging (MR MPI).
The main objectives of the study are:
- to evaluate feasibility of low - dose regadenoson dynamic computed tomography myocardial imaging protocol
- to assess the diagnostic value of quantitative dynamic CTP based absolute parameters (myocardial blood flow - MBF, myocardial blood volume - MBV, perfused capillary blood volume - PCBV, peak value - PV, time to peak - TTP) in reference to magnetic resonance myocardial perfusion imaging
- to assess the diagnostic value of quantitative dynamic CTP based relative parameters (relative myocardial blood flow - MBFR, relative myocardial blood volume - MBVR, relative perfused capillary blood volume - PCBVR, relative peak value - PVR, relative time to peak - TTPR) in reference to magnetic resonance myocardial perfusion imaging
- evaluation of safety of regadenoson low-dose dynamic CTP.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population as described in inclusion and exclusion criteria.
Key inclusion criteria (4 listed)
- age over 18 years
- signing written, informed consent by the patient for participation in the study
- patients who are asymptomatic or with symptoms of stable coronary heart disease
- intermediate coronary artery stenosis of at least one coronary artery in CTCA
Key exclusion criteria (11 listed)
- the symptoms of unstable ischemic heart disease and /or myocardial infarction,
- the history of myocardial infarction
- patients with impaired renal function (GFR <60 mL)
- contraindications for computed tomography or magnetic resonance imaging (including pregnancy, the presence of a cardiac pacemaker or cardioverter-defibrillator, claustrophobia, the presence of metal elements, etc.);
- contraindications to the administration of iodine contrast media (including allergy to contrast, unstable hyperthyroidism, etc.)
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
Evaluation of feasibility of regadenoson low - dose dynamic computed tomography perfusion protocol.
Time frame: 24 months
Evaluation of the quality of CTP images asessed by experienced readers.
Assessment of ischemia in regadenoson low-dose dynamic CTP in reference to magnetic resonance myocardial perfusion imaging (MR MPI).
Time frame: 24 months
The presence of ischemia in CTP per myocardial segment.
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 17 Sep 2019.
- 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.
Cezary Kepka, MD, PhD principal investigator
Institute of Cardiology, warsaw, PL
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 Perfusion Imaging and Computed Tomography, run by National Institute of Cardiology, Warsaw, Poland at 1 site in Poland.
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 4 inclusion and 11 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 17 Sep 2019. 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 Poland. 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?
Evaluation of feasibility of regadenoson low - dose dynamic computed tomography perfusion protocol. (time frame: 24 months). 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 17 Sep 2019; AzTrials last refreshed its copy on 6 Nov 2026.