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

NCT03917199 | Completed

• 1 other identifier: 2015/19/B/NZ5/03502
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Myocardial Perfusion Imaging; Computed Tomography; Coronary Artery Disease

Keywords

myocardial perfusion imaging; computed tomography perfusion; regadenoson; dynamic perfusion; coronary artery disease

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Other Outcomes (2)

• Evaluation of radiation dose during regadenoson low-dose dynamic CTP.

  24 months

• Evaluation of contrast agent dose during regadenoson low-dose dynamic CTP.

  24 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Study population as described in inclusion and exclusion criteria.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Cardiology, Warsaw, Poland: lead
• National Science Centre, Poland: collaborator

Study Sites (1)

Institute of Cardiology

Warsaw, 04-628, Poland

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Cezary Kepka, MD, PhD

  Institute of Cardiology, warsaw, PL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2017
• First Posted: April 16, 2019
• Study Start: November 1, 2016
• Primary Completion: July 1, 2019
• Study Completion: July 11, 2019
• Last Updated: September 17, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)