Utility of Regadenoson Low-dose Dynamic Computed Tomograp... | NCT03917199

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

NCT03917199

Sponsor

National Institute of Cardiology, Warsaw, Poland

Status

Completed

Last Update Posted

Sep 17, 2019Actual

Enrollment

60Actual

Phase

Not provided

Conditions

Myocardial Perfusion Imaging
Computed Tomography
Coronary Artery Disease

Interventions

Not provided

Countries

Poland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2016

Primary Completion Date

Jul 2019Actual

Completion Date

Jul 11, 2019Actual

First Submitted Date

Mar 2, 2017

First Submission Date that Met QC Criteria

Apr 12, 2019

First Posted Date

Apr 16, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 16, 2019

Last Update Posted Date

Sep 17, 2019Actual

Name	Class
National Science Centre, Poland	OTHER_GOV

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

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

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Study population as described in inclusion and exclusion criteria.

Sampling Method

Probability Sample

Name	Affiliation	Role
Cezary Kepka, MD, PhD	Institute of Cardiology, warsaw, PL	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Institute of Cardiology		Warsaw		04-628	Poland

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases