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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03917199

Acronym

ULYSSES

Enrollment

Registered

2019-04-16

Start date

2016-11-30

Completion date

2019-07-11

Last updated

2019-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Computed Tomography, Coronary Artery Disease, Myocardial Perfusion Imaging

Keywords

myocardial perfusion imaging, computed tomography perfusion, regadenoson, dynamic perfusion, coronary artery disease

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Evaluation of feasibility of regadenoson low - dose dynamic computed tomography perfusion protocol.	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).	24 months	The presence of ischemia in CTP per myocardial segment.

Other

Measure	Time frame	Description
Evaluation of radiation dose during regadenoson low-dose dynamic CTP.	24 months	Assessment of DLP (dose lenght product).
Evaluation of contrast agent dose during regadenoson low-dose dynamic CTP.	24 months	Assessment of contast agent dose (ml).

Countries

Poland

Outcome results