Clinical trial NCT03129503: Optical Coherence Tomography in Acute Coronary Syndrome
Official title: Optical Coherence Tomography in Acute Coronary Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Coronary Syndrome
STEMI - ST Elevation Myocardial Infarction
NSTEMI - Non-ST Segment Elevation MI
Atherosclerosis, Coronary
Keywords: Optical coherence tomography (OCT)
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Berlin Institut of Health (BIH), Germany
First posted: 2017-04-26
Enrollment: 414
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ACS Patients at Charité University Hospital including all sites

* Campus Benjamin Franklin (CBF)
* Campus Virchow Klinikum (CVK)
* Campus Mitte (CCM)

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Men and Women (aim: consecutive)
2. Age 18 to 85 years old.
3. ACS as trigger event - (ESC guidelines) being:

   1. Acute cardiac chest pain or angina equivalent consistent with moderate to high-risk unstable angina or myocardial infarction, lasting more than 10 minutes duration during 72 hours before invasive examination AND
   2. Evidence for ACS requiring catheterization documented by a) elevated enzymes (CK-MB or hs-Troponin I/T \> 99th percentile or in-/decrease) AND/OR
   3. ECG with ST-depression \>1mm in 2 or more contiguous leads after the J-point AND/OR transient ST-elevation \>1mm in 2 or more contiguous leads lasting \<30 min OR c) STE-ACS with onset \< 24 hours previously and chest pain \>30 min ST-elevation \>1mm in 2 or more contiguous leads or new left bundle block.
4. Written informed consent
5. 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:

1. Active pregnancy.
2. Active sepsis.
3. Acute psychotic disease.
4. Known systolic heart failure with left-ventricular ejection fraction (LV-EF≤ 30 %).
5. Cardiogenic shock or heart failure requiring intubation, inotropes; diuretics or mechanical circulation support.
6. Refractory ventricular arrhythmia requiring pharmacologic or defibrillator therapy.
7. Patients who had received heart transplantation or any other organ transplant or are on waiting list.
8. Renal insufficiency with serum-creatinine ≥ 1.5 mg/dl.
9. 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.
10. Prior participation in this study or in other investigational studies, that have not reached its primary endpoint.
11. Unprotected left main- CAD with ≥ 50% stenosis.
12. ACS with culprit lesion in a bypass graft or ACS caused by stent-thrombosis.
13. Extent and severity of CAD is such that investigator believes it is likely that bypass surgery will be required within 1 year of enrollment.
14. No suitable anatomy of "culprit lesion" for OCT:

    * severe calcification or extreme tortuosity of "culprit lesion".
    * culprit lesion with very distal location.
    * infarct vessels with an diameter \> 4 mm or \< 2 mm.
    * STE-ACS: "No-reflow" (TIMI 0-I) after thrombus aspiration/slight pre- dilatation

Primary outcomes:
measure: Major adverse cardiovascular Events (MACCE)
timeFrame: 2 years after ACS
Secondary outcomes:
measure: Rehospitalization Rate for Angina pectoris
timeFrame: 2 years after ACS
measure: Major adverse cardiovascular Events (MACCE)
timeFrame: 30 days, 90 days, 12 months and 5 years after ACS
measure: Intima /media thickness
timeFrame: Day 90 after ACS
measure: Global and regional left-ventricular systolic and diastolic function
timeFrame: After ACS and 90 days after ACS
measure: Frequency and severity of angina
timeFrame: at day 90,12 and 24 months after ACS
measure: Pulse-wave-velocity (PWV), Augmentation index (AI) and Sub-endocardial Viability Ratio (SEVR).
timeFrame: Day 90 after ACS
measure: Lesion Coverage
timeFrame: within 6 weeks to 3 months
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charite University Campus Mitte
city: Berlin
country: Germany
facility: Charite University Campus Benjamin Franklin
city: Berlin
country: Germany
facility: Charite University Campus Virchow-Klinikum
Study officials:
affiliation: Charite - University Medicine Berlin - Department for cardiology
name: David M Leistner, MD
role: STUDY_CHAIR
affiliation: Charite - University Medicine Berlin - Department for cardiology
name: Ulf Landmesser, MD
role: STUDY_CHAIR
References:
citation: 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.