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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03917199
Recruitment Status : Completed
First Posted : April 16, 2019
Last Update Posted : September 17, 2019
Sponsor:
Collaborator:
National Science Centre, Poland
Information provided by (Responsible Party):
National Institute of Cardiology, Warsaw, Poland

Tracking Information
First Submitted Date March 2, 2017
First Posted Date April 16, 2019
Last Update Posted Date September 17, 2019
Study Start Date November 2016
Actual Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 12, 2019)
  • 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.
  • 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: April 12, 2019)
  • Evaluation of radiation dose during regadenoson low-dose dynamic CTP. [ Time Frame: 24 months ]
    Assessment of DLP (dose lenght product).
  • Evaluation of contrast agent dose during regadenoson low-dose dynamic CTP. [ Time Frame: 24 months ]
    Assessment of contast agent dose (ml).
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Utility of Regadenoson Low-dose Dynamic Computed Tomography for Myocardial Perfusion Assesment (ULYSSES Study).
Official Title Utility of Regadenoson Low-dose Dynamic Computed Tomography for Myocardial Perfusion Assesment (ULYSSES Study).
Brief 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).
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Study population as described in inclusion and exclusion criteria.
Condition
  • Myocardial Perfusion Imaging
  • Computed Tomography
  • Coronary Artery Disease
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 12, 2019)		 60
Original Estimated Enrollment Same as current
Actual Study Completion Date July 11, 2019
Actual Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Poland
Removed Location Countries  
 
Administrative Information
NCT Number NCT03917199
Other Study ID Numbers 2015/19/B/NZ5/03502
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party National Institute of Cardiology, Warsaw, Poland
Original Responsible Party Same as current
Current Study Sponsor National Institute of Cardiology, Warsaw, Poland
Original Study Sponsor Same as current
Collaborators National Science Centre, Poland
Investigators
Principal Investigator: Cezary Kepka, MD, PhD Institute of Cardiology, warsaw, PL
PRS Account National Institute of Cardiology, Warsaw, Poland
Verification Date September 2019