Optical Coherence Tomography in Acute Coronary Syndrome (OPTICO-ACS)

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Acute Coronary Syndrome; NSTEMI - Non-ST Segment Elevation MI; STEMI - ST Elevation Myocardial Infarction; Atherosclerosis, Coronary

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.

• Study Type: Observational
• Enrollment (Anticipated): 414

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Charite University Campus Mitte
  • Berlin, Germany, 12200
    • Charite University Campus Benjamin Franklin
  • Berlin, Germany, 13353
    • Charite University Campus Virchow-Klinikum

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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)

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Acute coronary syndrome (ACS); Patients with STE- or NSTE-ACS (acute coronary syndrome)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major adverse cardiovascular Events (MACCE)	powered	2 years after ACS

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Collaborators: Berlin Institut of Health (BIH), Germany
• Investigators: Study Chair: David M Leistner, MD, Charite - University Medicine Berlin - Department for cardiology; Study Chair: Ulf Landmesser, MD, Charite - University Medicine Berlin - Department for cardiology

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2017
• Primary Completion (Anticipated): March 31, 2024
• Study Completion (Anticipated): March 31, 2024

Study Registration Dates

• First Submitted: April 23, 2017
• First Submitted That Met QC Criteria: April 25, 2017
• First Posted (Actual): April 26, 2017

Study Record Updates

• Last Update Posted (Actual): July 23, 2019
• Last Update Submitted That Met QC Criteria: July 22, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Optical coherence tomography (OCT)
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Disease; Coronary Disease; Myocardial Infarction; Infarction; Coronary Artery Disease; Myocardial Ischemia; Syndrome; ST Elevation Myocardial Infarction; Atherosclerosis; Acute Coronary Syndrome
• Other Study ID Numbers: 1.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No