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Replacement of invasive diagnostic coronary procedures by innovative noninvasive Imaging Technologies


- candidate number25275
- NTR NumberNTR6085
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-sep-2016
- Secondary IDsNL 57105.042.16 METc 2016/240
- Public TitleReplacement of invasive diagnostic coronary procedures by innovative noninvasive Imaging Technologies
- Scientific TitleReplacement of invasive diagnostic coronary procedures by innovative noninvasive Imaging Technologies
- ACRONYMREPLACE-it
- hypothesisThe hypothesis is that non invasive imaging techniques (CTA + stress MR perfusion) are a suitable replacement for diagnostic Invasive Coronary Angiography (ICA) in the diagnosis of Coronary Artery Disease.
- Healt Condition(s) or Problem(s) studiedCoronary artery disease, Non-invasive, Imaging
- Inclusion criteriaAll patients >18 years of age referred for ICA as part of standard clinical care for evaluation of suspected CAD
- Exclusion criteriaMajor exclusion criteria are:
- Unable to provide written informed consent
- ICA planned for other reasons than suspected obstructive CAD (e.g. screening prior to lung transplantation, valvular surgery, or ICD implantation)
- Significant arrhythmia deemed to interfere with successful ECG triggered non-invasive imaging as judged by a cardiologist.
- Renal insufficiency: GFR <50ml/min
- Known anaphylactic allergy to iodine
- Known severe comorbidities with a life expectancy of less than 1 year
- Known severe claustrophobia
- Known contra-indications for beta-blocker or adenosine
- Instable coronary artery disease (acute coronary syndrome or instable angina)
- Other contraindications for CTA or MR perfusion (e.g. presence of incompatible pacemaker or ICD devices/leads, pregnancy, BMI >35 kg/m2).
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-nov-2016
- planned closingdate1-nov-2019
- Target number of participants440
- InterventionsBefore ICA patients will undergo both CT Coronary Angiography (CTA) and adenosine MR perfusion imaging. In case of significant CAD during ICA, a second MR perfusion scan after the intervention will
- Primary outcomeThe primary endpoint is the performance of noninvasive imaging (combined CTA and MR perfusion) to diagnose flow-limiting CAD compared to the reference standard of ICA.
- Secondary outcomeSecondary endpoints include the performance of individual components of the noninvasive imaging approach, the ability to guide revascularization strategy and the prediction of improvement of perfusion after revascularization.
- Timepoints01-11-16: Start inclusion
01-11-17: 100 patients included
01-09-18: 400 patients included
01-06-19: Final results
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES R. van Dijk
- CONTACT for SCIENTIFIC QUERIES R. van Dijk
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- Publications
- Brief summaryCoronary Artery Disease (CAD) is expected to remain the leading cause of death for the next 20 years, posing a major burden on society. A considerable proportion of costs related to the management of (suspected) CAD are due to Invasive Coronary Angiography (ICA), which is indicated in high-risk patients and in patients with noninvasive testing suggestive of significant CAD. Noninvasive imaging techniques show promising potential to replace a large proportion of the current practice of ICA. The REPLACE-IT study is a prospective single-centre observational study with the aim to establish a noninvasive, quantitative imaging approach to (1.) determine if flow or perfusion-limiting CAD is present, (2.) guide the indication for percutaneous intervention or bypass grafting, and (3.) predict the hemodynamic improvement after revascularization. Non-acute, symptomatic patients scheduled to undergo elective ICA are eligible for this study. In total 440 men and women (aiming to include equal numbers by gender) will be recruited from the cardiology outpatient clinic at the UMCG, where we see approximately 2500 eligible patients annually. Patients will undergo a diagnostic algorithm consisting of coronary (Computed Tomography Angiogram) CTA and myocardialMagnetic Resonance (MR) perfusion before ICA. A second MR perfusion will be performed only when the patient received a coronary intervention. The primary endpoint is the comparison of noninvasive imaging (combined CTA and MR perfusion) to diagnose flow limiting CAD with reference standard of ICA+/-FFR. Secondary endpoints include the performance of individual components of the noninvasive imaging approach, the ability to guide revascularization strategy and the prediction of improvement of perfusion after revascularization. We expect to establish a noninvasive imaging approach to reduce the number of ICA.
- Main changes (audit trail)
- RECORD9-sep-2016 - 11-dec-2016


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