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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03917199
Other study ID # 2015/19/B/NZ5/03502
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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