Acute Coronary Syndrome, Coronary Artery Disease, Myocardial Infarction
Conditions
Keywords
Vulnerable plaque, Optical coherence Tomography, OCT
Brief summary
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).
Detailed description
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.
Interventions
DEVICECoronary Optical Coherence tomography
Optical coherence tomography imaging is performed of non-obstructive, non-culprit coronary lesions to assess plaque morphology.
Sponsors
Radboud University Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Informed consent must be obtained. * Patients with STEMI or NSTEMI and residual, non-culprit CAD, with the possibility of plaque vulnerability. * Residual plaque(s) is(are) non-obstructive (FFR≥0.80).
Exclusion criteria
* Refusal or inability to provide informed consent. * \< 18 years of age * Hemodynamic instability, respiratory failure, Kilip class ≥ 3. * Previous Coronary Artery Bypass Grafting (CABG). * Indication for revascularization by CABG. * Anatomy or lesions unsuitable for OCT catheter crossing or imaging (aorta-ostial lesions, small diameter segment, severe calcifications, lesion is too distal for OCT catheter) * Pregnancy. * Estimated life expectancy \< 3 year
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major Adverse Cardiac Events | 2 years | Composite of all cause mortality, non-fatal myocardial infarction or unplanned revascularization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major Adverse Cardiac Events | 1 year | Composite of all cause mortality, non-fatal myocardial infarction or unplanned revascularization. |
| Target lesion Failure | 2 and 5 years | Cardiac death caused by target lesion, myocardial infarction caused by target lesion, revascularisation of target lesion |
Countries
Netherlands
Outcome results
None listed