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Acute Coronary SyndromeOPTICO-ACSNCT03129503

Optical Coherence Tomography in Acute Coronary Syndrome

An observational study of Acute Coronary Syndrome and STEMI - ST Elevation Myocardial Infarction, run by Charite University, Berlin, Germany at 3 sites in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 85 years
How many people
414 participants
Where
3 sitesGermany
Study dates
28 Apr 2017to 31 Mar 2024
How long will I take part?
5 Years
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • Adult, Older adult

Study population: ACS Patients at Charité University Hospital including all sites * Campus Benjamin Franklin (CBF) * Campus Virchow Klinikum (CVK) * Campus Mitte (CCM)

Who may be able to join

  • Men and Women (aim: consecutive)
  • Age 18 to 85 years old.
  • ACS as trigger event - (ESC guidelines) being:
  • 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
  • Evidence for ACS requiring catheterization documented by a) elevated enzymes (CK-MB or hs-Troponin I/T > 99th percentile or in-/decrease) AND/OR
  • 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.
  • 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.

Who cannot join

  • 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.
Show all 18Show fewer
  • 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:
  • 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

Trial locations and contacts

3 sites in 1 country.

Germany3 sites

  • Charite University Campus Mitte

    Berlin, 10117

  • Charite University Campus Benjamin Franklin

    Berlin, 12200

  • Charite University Campus Virchow-Klinikum

    Berlin, 13353

Other trials in Germany

About this study

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.

Keywords
Optical coherence tomography (OCT)
Medical subject headings
Acute Coronary Syndrome, ST Elevation Myocardial Infarction, Non-ST Elevated Myocardial Infarction, Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03129503
Study groupRoleWhat they receive
Acute coronary syndrome (ACS)Patients with STE- or NSTE-ACS (acute coronary syndrome)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Major adverse cardiovascular Events (MACCE)

    powered

    Measured: 2 years after ACS

Secondary outcomes (7)

  1. Rehospitalization Rate for Angina pectoris

    Measured: 2 years after ACS

  2. Major adverse cardiovascular Events (MACCE)

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

  3. Intima /media thickness

    by sonography

    Measured: Day 90 after ACS

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

    by echocardiography

    Measured: After ACS and 90 days after ACS

  5. Frequency and severity of angina

    by Seattle Angina questionnaire

    Measured: 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

    Measured: Day 90 after ACS

  7. Lesion Coverage

    by OCT

    Measured: within 6 weeks to 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Apr 2017
  2. Study start28 Apr 2017
  3. Primary completion31 Mar 2024 (estimated)
  4. Study completion31 Mar 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
414 participants (estimated)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT03129503
Sponsor's protocol ID
1.0
Acronym
OPTICO-ACS
Status last verified
Jul 2019
First submitted
23 Apr 2017
Last updated
23 Jul 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Panuccio G, De Rosa S, Anwari E, Torella D, Meteva D, Ide S, Shiraki T, Sakata Y, Weiner BG, Al Harbi AS, Tonini G, Seppelt C, Gerhardt T, Rai H, Skurk C, Dreger H, Trippel T, Haghikia A, Joner M, Leistner DM, Landmesser U, Abdelwahed YS. Optical Coherence Tomography-Defined Vulnerable Plaques and Intracoronary Thrombus in Acute Coronary Syndromes: Insights From the OPTICO-ACS Program. J Am Heart Assoc. 2026 Aug 20:e047485. doi: 10.1161/JAHA.125.047485. Online ahead of print.

    PubMed 42622142

  • 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.

    PubMed 38141724

  • 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.

    PubMed 37395586

  • 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

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Coronary Syndrome and STEMI - ST Elevation Myocardial Infarction, run by Charite University, Berlin, Germany at 3 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major adverse cardiovascular Events (MACCE) (time frame: 2 years after ACS). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03129503, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2019.

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