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

Coronary Artery Disease Clinical Trial

— ULYSSES  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03917199
• Other study ID #: 2015/19/B/NZ5/03502
• Status: Completed
• Start date: November 2016
• Est. completion date: July 11, 2019

Study information

• Verified date: September 2019
• Source: Institute of Cardiology, Warsaw, Poland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Computed Tomography
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Myocardial Perfusion Imaging

Locations

Country	Name	City	State
Poland	Institute of Cardiology	Warsaw

Sponsors (2)

Lead Sponsor	Collaborator
Institute of Cardiology, Warsaw, Poland	National Science Centre, Poland

Country where clinical trial is conducted

Poland, 

Outcome

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