Utility of Regadenoson Low-dose Dynamic Computed Tomography for Myocardial Perfusion Assesment (ULYSSES Study). (ULYSSES)
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|ClinicalTrials.gov Identifier: NCT03917199|
Recruitment Status : Completed
First Posted : April 16, 2019
Last Update Posted : September 17, 2019
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|Condition or disease|
|Myocardial Perfusion Imaging Computed Tomography Coronary Artery Disease|
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 Type :||Observational|
|Actual Enrollment :||60 participants|
|Official Title:||Utility of Regadenoson Low-dose Dynamic Computed Tomography for Myocardial Perfusion Assesment (ULYSSES Study).|
|Study Start Date :||November 2016|
|Actual Primary Completion Date :||July 2019|
|Actual Study Completion Date :||July 11, 2019|
- 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.
- Evaluation of radiation dose during regadenoson low-dose dynamic CTP. [ Time Frame: 24 months ]Assessment of DLP (dose lenght product).
- Evaluation of contrast agent dose during regadenoson low-dose dynamic CTP. [ Time Frame: 24 months ]Assessment of contast agent dose (ml).
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Probability Sample|
- 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
- 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.);
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03917199
|Institute of Cardiology|
|Warsaw, Poland, 04-628|
|Principal Investigator:||Cezary Kepka, MD, PhD||Institute of Cardiology, warsaw, PL|
|Responsible Party:||Institute of Cardiology, Warsaw, Poland|
|Other Study ID Numbers:||
|First Posted:||April 16, 2019 Key Record Dates|
|Last Update Posted:||September 17, 2019|
|Last Verified:||September 2019|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
myocardial perfusion imaging
computed tomography perfusion
coronary artery disease
Coronary Artery Disease
Arterial Occlusive Diseases