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NCT Number: NCT03917199

Utility of Regadenoson Low-dose Dynamic Computed Tomography for Myocardial Perfusion Assesment (ULYSSES 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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute of Cardiology

Warsaw, 04-628, Poland

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 (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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

Other outcomes

  1. Evaluation of radiation dose during regadenoson low-dose dynamic CTP.

    Time frame: 24 months

    Assessment of DLP (dose lenght product).

  2. Evaluation of contrast agent dose during regadenoson low-dose dynamic CTP.

    Time frame: 24 months

    Assessment of contast agent dose (ml).

Sponsors and collaborators

Lead sponsor

National Institute of Cardiology, Warsaw, Poland

Other

Collaborators

  • National Science Centre, Poland

Registry information

Acronym: ULYSSES

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Apr 16, 2019
Registry last updated
Sep 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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