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

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ClinicalTrials.gov Identifier: NCT03917199
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : April 16, 2019
Sponsor:
Collaborator:
National Science Centre, Poland
Information provided by (Responsible Party):
Institute of Cardiology, Warsaw, Poland

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).

Condition or disease
Myocardial Perfusion Imaging Computed Tomography Coronary Artery Disease

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.

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Utility of Regadenoson Low-dose Dynamic Computed Tomography for Myocardial Perfusion Assesment (ULYSSES Study).
Study Start Date : November 2016
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: CT Scans
Drug Information available for: Regadenoson




Primary Outcome Measures :
  1. 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.

  2. 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.


Other Outcome Measures:
  1. Evaluation of radiation dose during regadenoson low-dose dynamic CTP. [ Time Frame: 24 months ]
    Assessment of DLP (dose lenght product).

  2. Evaluation of contrast agent dose during regadenoson low-dose dynamic CTP. [ Time Frame: 24 months ]
    Assessment of contast agent dose (ml).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Study population as described in inclusion and exclusion criteria.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03917199


Contacts
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Contact: Cezary Kępka, MD PhD ckepka@ikard.pl
Contact: Anna Oleksiak, MD aoleksiak@ikard.pl

Locations
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Poland
Institute of Cardiology Recruiting
Warsaw, Poland, 04-628
Contact: Cezary Kępka, MD PhD       ckepka@ikard.pl   
Principal Investigator: Cezary Kępka, MD PhD         
Sub-Investigator: Anna Oleksiak, MD         
Sub-Investigator: Mariusz Kruk, MD PhD         
Sub-Investigator: Marcin Demkow, MD PhD         
Sponsors and Collaborators
Institute of Cardiology, Warsaw, Poland
National Science Centre, Poland
Investigators
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Principal Investigator: Cezary Kepka, MD, PhD Institute of Cardiology, warsaw, PL

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Responsible Party: Institute of Cardiology, Warsaw, Poland
ClinicalTrials.gov Identifier: NCT03917199     History of Changes
Other Study ID Numbers: 2015/19/B/NZ5/03502
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Institute of Cardiology, Warsaw, Poland:
myocardial perfusion imaging
computed tomography perfusion
regadenoson
dynamic perfusion
coronary artery disease

Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Regadenoson
Adenosine A2 Receptor Agonists
Purinergic P1 Receptor Agonists
Purinergic Agonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs