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Status unknownNCT03129503OPTICO-ACSUpdated Jul 23, 2019

Optical Coherence Tomography in Acute Coronary Syndrome

An observational study in Acute Coronary Syndrome, STEMI - ST Elevation Myocardial Infarction and NSTEMI - Non-ST Segment Elevation MI, sponsored by Charite University, Berlin, Germany. Status unknown at 3 sites in Germany. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2019-07-23.

Sponsored by Charite University, Berlin, Germany · Observational

The sponsor has not verified this record recently (last verified Jul 2019), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
414
Ages
18 Years to 85 Years
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Acute Coronary Syndrome
  • STEMI - ST Elevation Myocardial Infarction
  • NSTEMI - Non-ST Segment Elevation MI
  • Atherosclerosis, Coronary

Keywords

  • Optical coherence tomography (OCT)
03

In context

Myocardial Infarction

2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.

This study's planned enrollment of 414 is below the median of 500 across 983 observational studies indexed under Myocardial Infarction.

Browse Myocardial Infarction studies →

Lead sponsor

Charite University, Berlin, Germany is the lead sponsor of 836 studies on the registry; 129 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
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)

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

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
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
414 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • Acute coronary syndrome (ACS)

    Patients with STE- or NSTE-ACS (acute coronary syndrome)

06

What researchers measure

Primary outcomes

  1. Major adverse cardiovascular Events (MACCE)

    powered

    Time frame: 2 years after ACS

Secondary outcomes

  1. Rehospitalization Rate for Angina pectoris

    Time frame: 2 years after ACS

  2. Major adverse cardiovascular Events (MACCE)

    Time frame: 30 days, 90 days, 12 months and 5 years after ACS

  3. Intima /media thickness

    by sonography

    Time frame: Day 90 after ACS

  4. Global and regional left-ventricular systolic and diastolic function

    by echocardiography

    Time frame: After ACS and 90 days after ACS

  5. Frequency and severity of angina

    by Seattle Angina questionnaire

    Time frame: at day 90,12 and 24 months after ACS

  6. Pulse-wave-velocity (PWV), Augmentation index (AI) and Sub-endocardial Viability Ratio (SEVR).

    by SphygmoCor system

    Time frame: Day 90 after ACS

  7. Lesion Coverage

    by OCT

    Time frame: within 6 weeks to 3 months

07

Study locations

3 sites
  • Charite University Campus Mitte
    Berlin, 10117, Germany
  • Charite University Campus Benjamin Franklin
    Berlin, 12200, Germany
  • Charite University Campus Virchow-Klinikum
    Berlin, 13353, Germany
08

References and documents

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. PubMed 33080003 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 23, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03129503
Lead sponsor
Charite University, Berlin, Germany
Collaborators
Berlin Institut of Health (BIH), Germany
Responsible party
David Manuel Leistner (PD Dr. med., Charite University, Berlin, Germany) — Principal investigator
First posted
Apr 26, 2017
Start date
Apr 28, 2017
Primary completion
Mar 31, 2024 (estimated)
Completion
Mar 31, 2024 (estimated)
Last update
Jul 23, 2019

Study contacts

David M Leistner, MD
study chair · Charite - University Medicine Berlin - Department for cardiology
Ulf Landmesser, MD
study chair · Charite - University Medicine Berlin - Department for cardiology

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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