An interventional study of Coronary Optical Coherence tomography in Myocardial Infarction, Acute Coronary Syndrome and Coronary Artery Disease, sponsored by Radboud University Medical Center. Active, not recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-17.
Sponsored by Radboud University Medical Center · Not applicable, Interventional, and Diagnostic
The objective of this study is to compare the clinical outcome of Non-ST-elevation myocardial infarction (NSTEMI) and ST-elevation myocardial infarction (STEMI) patients with non-obstructive, non-culprit coronary lesions and either presence or absence of vulnerable plaque characteristics as assessed by optical coherence tomography (OCT).
Despite major advances in the treatment of acute coronary syndromes a large proportion of patients is still at risk for new coronary events after experiencing an acute coronary syndrome (ACS). Detection of residual vulnerable plaques after ACS using OCT potentially identifies patients at high risk for new coronary events. However, no prospectively collected data on the prognostic power of OCT for plaque rupture are available at this moment. To design trials aimed to reduce events in patients with vulnerable plaques it is required to collect such prospective data on the relation between OCT derived characteristics of vulnerability and clinical outcome.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's enrollment of 438 is above the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Radboud University Medical Center is the lead sponsor of 959 studies on the registry; 134 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Coronary OCT imaging will be performed of fractional flow reserve (FFR) negative lesions to assess plaque morphology.
Device: Coronary Optical Coherence tomography
Optical coherence tomography imaging is performed of non-obstructive, non-culprit coronary lesions to assess plaque morphology.
Major Adverse Cardiac Events
Composite of all cause mortality, non-fatal myocardial infarction or unplanned revascularization.
Time frame: 2 years
Major Adverse Cardiac Events
Composite of all cause mortality, non-fatal myocardial infarction or unplanned revascularization.
Time frame: 1 year
Major Adverse Cardiac Events
Composite of all cause mortality, non-fatal myocardial infarction or unplanned revascularization.
Time frame: 5 years
Target lesion Failure
Cardiac death caused by target lesion, myocardial infarction caused by target lesion, revascularisation of target lesion
Time frame: 2 and 5 years
Plan to share: Undecided
This study is active, not recruiting, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Radboud University Medical Center