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

September 16, 2019 updated by: Institute of Cardiology, Warsaw, Poland
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).

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Warsaw, Poland, 04-628
        • Institute of Cardiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Study population as described in inclusion and exclusion criteria.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of feasibility of regadenoson low - dose dynamic computed tomography perfusion protocol.
Time Frame: 24 months
Evaluation of the quality of CTP images asessed by experienced readers.
24 months
Assessment of ischemia in regadenoson low-dose dynamic CTP in reference to magnetic resonance myocardial perfusion imaging (MR MPI).
Time Frame: 24 months
The presence of ischemia in CTP per myocardial segment.
24 months

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Cardiology, Warsaw, Poland

Collaborators

National Science Centre, Poland

Investigators

  • Principal Investigator: Cezary Kepka, MD, PhD, Institute of Cardiology, warsaw, PL

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Actual)

July 1, 2019

Study Completion (Actual)

July 11, 2019

Study Registration Dates

First Submitted

March 2, 2017

First Submitted That Met QC Criteria

April 12, 2019

First Posted (Actual)

April 16, 2019

Study Record Updates

Last Update Posted (Actual)

September 17, 2019

Last Update Submitted That Met QC Criteria

September 16, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015/19/B/NZ5/03502

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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