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| Name | Class |
|---|---|
| Berlin Institut of Health (BIH), Germany | UNKNOWN |
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The OPTICO-ACS- study program - combining for the first time in vivo characterization of the ACS-causing "culprit lesion" by intracoronary imaging technique with optical coherence tomography (OCT) and molecular analysis of immune-cells derived from the culprit coronary thrombus and biochemical analyses in patients with acute-coronary-syndrome (ACS).
Using a translational scientific approach the study aims to (a) get a better insight into the different pathophysiological processes in both clinical settings - plaque rupture (RFC) and plaque-erosion (IFC) with focus on to the inflammatory process and molecular mechanisms (b) identify special signatures including clinical and biochemical markers as biomarkers subject to different culprit plaques types and (c) to test its prognostic implications in patients after ACS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acute coronary syndrome (ACS) | Patients with STE- or NSTE-ACS (acute coronary syndrome) |
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| Measure | Description | Time Frame |
|---|---|---|
| Major adverse cardiovascular Events (MACCE) | powered | 2 years after ACS |
| Measure | Description | Time Frame |
|---|---|---|
| Rehospitalization Rate for Angina pectoris | 2 years after ACS | |
| Major adverse cardiovascular Events (MACCE) | 30 days, 90 days, 12 months and 5 years after ACS | |
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Inclusion Criteria:
Men and Women (aim: consecutive)
Age 18 to 85 years old.
ACS as trigger event - (ESC guidelines) being:
Written informed consent
Patients must have at least coronary one-vessel disease with one angiographically detectable "culprit lesion" (or in case of more > 1 lesion all lesions have to be in one "culprit vessel") in a native coronary vessel requiring PCI. Identification of this lesion as the "culprit lesion" has to be in line with other non-invasive findings (ECG-leads; regional wall motion abnormalities in echocardiography). Other "non-culprit-lesions" are allowed to have significant stenosis requiring interventional revascularization in a staged procedure.
Exclusion Criteria:
Active pregnancy.
Active sepsis.
Acute psychotic disease.
Known systolic heart failure with left-ventricular ejection fraction (LV-EF≤ 30 %).
Cardiogenic shock or heart failure requiring intubation, inotropes; diuretics or mechanical circulation support.
Refractory ventricular arrhythmia requiring pharmacologic or defibrillator therapy.
Patients who had received heart transplantation or any other organ transplant or are on waiting list.
Renal insufficiency with serum-creatinine ≥ 1.5 mg/dl.
Patients with other medical illness (i.e. cancer) or recent history of substance abuse, that may cause non-compliance with the investigational plan, confound the data interpretation or is associated with an anticipated limited life-expectancy less than one year.
Prior participation in this study or in other investigational studies, that have not reached its primary endpoint.
Unprotected left main- CAD with ≥ 50% stenosis.
ACS with culprit lesion in a bypass graft or ACS caused by stent-thrombosis.
Extent and severity of CAD is such that investigator believes it is likely that bypass surgery will be required within 1 year of enrollment.
No suitable anatomy of "culprit lesion" for OCT:
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ACS Patients at Charité University Hospital including all sites
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| Name | Affiliation | Role |
|---|---|---|
| David M Leistner, MD | Charite - University Medicine Berlin - Department for cardiology | Study Chair |
| Ulf Landmesser, MD | Charite - University Medicine Berlin - Department for cardiology | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charite University Campus Mitte | Berlin | 10117 | Germany | |||
| Charite University Campus Benjamin Franklin |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38141724 | Derived | Nelles G, Abdelwahed YS, Seppelt C, Meteva D, Stahli BE, Rai H, Seegers LM, Sieronski L, Musfeldt J, Gerhardt T, Riedel M, Skurk C, Haghikia A, Sinning D, Dreger H, Knebel F, Trippel TD, Krisper M, Klotsche J, Joner M, Landmesser U, Leistner DM. Cholesterol crystals at the culprit lesion in patients with acute coronary syndrome are associated with worse cardiovascular outcomes at two years follow up - results from the translational OPTICO-ACS study program. Int J Cardiol. 2024 Mar 15;399:131665. doi: 10.1016/j.ijcard.2023.131665. Epub 2023 Dec 22. | |
| 37395586 |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| D000072657 | ST Elevation Myocardial Infarction |
| D000072658 | Non-ST Elevated Myocardial Infarction |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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Blood and coronary thrombus
| Intima /media thickness |
by sonography |
| Day 90 after ACS |
| Global and regional left-ventricular systolic and diastolic function | by echocardiography | After ACS and 90 days after ACS |
| Frequency and severity of angina | by Seattle Angina questionnaire | at day 90,12 and 24 months after ACS |
| Pulse-wave-velocity (PWV), Augmentation index (AI) and Sub-endocardial Viability Ratio (SEVR). | by SphygmoCor system | Day 90 after ACS |
| Lesion Coverage | by OCT | within 6 weeks to 3 months |
| Berlin |
| 12200 |
| Germany |
| Charite University Campus Virchow-Klinikum | Berlin | 13353 | Germany |
| Derived |
| Seppelt C, Abdelwahed YS, Meteva D, Nelles G, Stahli BE, Erbay A, Krankel N, Sieronski L, Skurk C, Haghikia A, Sinning D, Dreger H, Knebel F, Trippel TD, Krisper M, Gerhardt T, Rai H, Klotsche J, Joner M, Landmesser U, Leistner DM. Coronary microevaginations characterize culprit plaques and their inflammatory microenvironment in a subtype of acute coronary syndrome with intact fibrous cap: results from the prospective translational OPTICO-ACS study. Eur Heart J Cardiovasc Imaging. 2024 Jan 29;25(2):175-184. doi: 10.1093/ehjci/jead154. |
| 33080003 | Derived | Leistner DM, Krankel N, Meteva D, Abdelwahed YS, Seppelt C, Stahli BE, Rai H, Skurk C, Lauten A, Mochmann HC, Frohlich G, Rauch-Krohnert U, Flores E, Riedel M, Sieronski L, Kia S, Strassler E, Haghikia A, Dirks F, Steiner JK, Mueller DN, Volk HD, Klotsche J, Joner M, Libby P, Landmesser U. Differential immunological signature at the culprit site distinguishes acute coronary syndrome with intact from acute coronary syndrome with ruptured fibrous cap: results from the prospective translational OPTICO-ACS study. Eur Heart J. 2020 Oct 1;41(37):3549-3560. doi: 10.1093/eurheartj/ehaa703. |
| D009203 |
| Myocardial Infarction |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D003327 | Coronary Disease |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |