Optical Coherence Tomography in Acute Coronary Syndrome

NCT ID: NCT03129503

Last Updated: 2019-07-23

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 414 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-04-28
• Study Completion Date: 2024-03-31

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.

Conditions

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Acute coronary syndrome (ACS)

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

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Berlin Institut of Health (BIH), Germany

UNKNOWN

Sponsor Role: collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

David Manuel Leistner

PD Dr. med.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David M Leistner, MD

Role: STUDY_CHAIR

Charite - University Medicine Berlin - Department for cardiology

Ulf Landmesser, MD

Role: STUDY_CHAIR

Charite - University Medicine Berlin - Department for cardiology

Locations

Charite University Campus Mitte

Berlin, , Germany

Charite University Campus Benjamin Franklin

Berlin, , Germany

Charite University Campus Virchow-Klinikum

Berlin, , Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 37395586 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33080003 (View on PubMed)

Other Identifiers

1.0

Identifier Type: -

Identifier Source: org_study_id