myocardial infarction
Conditions
Interventions
If an LRP is detected with IVUS/NIRS, these are treated with DEB
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Patient has an acute coronary syndrome without ST-segment elevation on the ECG (NSTE-ACS), including non-ST-elevation myocardial infarction and unstable angina pectoris. 2. An invasive revascularization strategy for NSTE-ACS with PCI is chosen. 3. The coronary arteries are open and patent on CTCA, thus feasible to scan all major coronary arteries with IVUS/NIRS.
Exclusion criteria
Exclusion criteria: Angiographic exclusion criteria: 1. Patient has additional lesions that cannot be treated during the index PCI and need staged PCI; 2. A chronic total occlusion is present; 3. Previous coronary artery bypass-grafting; 4. Patient has a major procedural complication of the index PCI (coronary perforation, coronary dissection); Clinical exclusion criteria: 5. Irregular heart rhythm, affecting the CT quality (i.e. atrial fibrillation or frequent premature ventricular contractions); 6. Technical aspects hampering appropriate CT assessment (i.e. the presence of extreme calcifications or extreme tortuosity); 7. Unstable patients (the presence of cardiogenic shock, need for intubation, need for inotropes); 8. Patients with ST-segment elevations on the ECG requiring immediate primary PCI; 9. Body weight > 250 kg; 10. Known renal insufficiency (estimated Glomerular Filtration Rate [eGFR]
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The difference in LCBImm4 between baseline and 9 months | — |
Secondary
| Measure | Time frame |
|---|---|
| * Changes in plaque volume and characteristics of LRPs treated with DEB measured by CTCA at 9-month follow-up, as compared to baseline; * Changes in perivascular fat as measured by CTCA at 9-month follow-up, as compared to baseline; * Flow-limiting dissection necessitating bail-out stent implantation; * Periprocedural myocardial infarction; * LRP lesion failure, defined as cardiac death, myocardial infarction, or ischemia-driven revascularization related to an identified non-culprit LRP lesion up to one-year follow-up; * Patient-oriented composite outcomes, defined as all-cause mortality, myocardial infarction, or any repeat revascularization up to one-year follow-up; * Additional IVUS + NIRS lesion characteristics (plaque volume, minimal lumen area); * Correlation of vulnerable plaque characteristics on CTCA with IVUS + NIRS at 9-months follow-up. | — |
Countries
Netherlands
Outcome results
None listed