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 : Recruiting
First Posted : April 16, 2019
Last Update Posted : April 16, 2019
|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|
|Estimated Enrollment :||60 participants|
|Official Title:||Utility of Regadenoson Low-dose Dynamic Computed Tomography for Myocardial Perfusion Assesment (ULYSSES Study).|
|Study Start Date :||November 2016|
|Estimated Primary Completion Date :||July 2019|
|Estimated Study Completion Date :||November 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).
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
|Contact: Cezary Kępka, MD PhDemail@example.com|
|Contact: Anna Oleksiak, MDfirstname.lastname@example.org|
|Institute of Cardiology||Recruiting|
|Warsaw, Poland, 04-628|
|Contact: Cezary Kępka, MD PhD email@example.com|
|Principal Investigator: Cezary Kępka, MD PhD|
|Sub-Investigator: Anna Oleksiak, MD|
|Sub-Investigator: Mariusz Kruk, MD PhD|
|Sub-Investigator: Marcin Demkow, MD PhD|
|Principal Investigator:||Cezary Kepka, MD, PhD||Institute of Cardiology, warsaw, PL|