Coronary Artery Disease Clinical Trial
— ULYSSESOfficial title:
Utility of Regadenoson Low-dose Dynamic Computed Tomography for Myocardial Perfusion Assesment (ULYSSES Study).
Verified date | September 2019 |
Source | Institute of Cardiology, Warsaw, Poland |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
Status | Completed |
Enrollment | 60 |
Est. completion date | July 11, 2019 |
Est. primary completion date | July 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Poland | Institute of Cardiology | Warsaw |
Lead Sponsor | Collaborator |
---|---|
Institute of Cardiology, Warsaw, Poland | National Science Centre, Poland |
Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Evaluation of radiation dose during regadenoson low-dose dynamic CTP. | Assessment of DLP (dose lenght product). | 24 months | |
Other | Evaluation of contrast agent dose during regadenoson low-dose dynamic CTP. | Assessment of contast agent dose (ml). | 24 months | |
Primary | Evaluation of feasibility of regadenoson low - dose dynamic computed tomography perfusion protocol. | Evaluation of the quality of CTP images asessed by experienced readers. | 24 months | |
Primary | Assessment of ischemia in regadenoson low-dose dynamic CTP in reference to magnetic resonance myocardial perfusion imaging (MR MPI). | The presence of ischemia in CTP per myocardial segment. | 24 months |
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