Clinical trial NCT03917199: Utility of Regadenoson Low-dose Dynamic Computed Tomography for Myocardial Perfusion Assesment (ULYSSES Study).
Official title: Utility of Regadenoson Low-dose Dynamic Computed Tomography for Myocardial Perfusion Assesment (ULYSSES Study).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocardial Perfusion Imaging
Computed Tomography
Coronary Artery Disease
Keywords: myocardial perfusion imaging
computed tomography perfusion
regadenoson
dynamic perfusion
coronary artery disease
Lead sponsor: National Institute of Cardiology, Warsaw, Poland
Sponsor class: OTHER
Collaborators: name: National Science Centre, Poland
First posted: 2019-04-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Study population as described in inclusion and exclusion criteria.

Brief 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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of feasibility of regadenoson low - dose dynamic computed tomography perfusion protocol.
timeFrame: 24 months
measure: Assessment of ischemia in regadenoson low-dose dynamic CTP in reference to magnetic resonance myocardial perfusion imaging (MR MPI).
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
measure: Evaluation of radiation dose during regadenoson low-dose dynamic CTP.
timeFrame: 24 months
measure: Evaluation of contrast agent dose during regadenoson low-dose dynamic CTP.
timeFrame: 24 months
Locations:
city: Warsaw
country: Poland
facility: Institute of Cardiology
Study officials:
affiliation: Institute of Cardiology, warsaw, PL
name: Cezary Kepka, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: