Optical Coherence Tomography in Acute Coronary Syndrome

NCT03129503 | Unknown DMC

• 1 other identifier: 1.0
• Study Type: observational
• Target: 414
• Locations: 1 country
• Sites: 3

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).

Conditions

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

Keywords

Optical coherence tomography (OCT)

Outcome Measures

Primary Outcomes (1)

• Major adverse cardiovascular Events (MACCE)

  powered

  2 years after ACS

Secondary Outcomes (7)

• 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

  Day 90 after ACS

• Global and regional left-ventricular systolic and diastolic function

  After ACS and 90 days after ACS

• Frequency and severity of angina

  at day 90,12 and 24 months after ACS

Study Arms (1)

Acute coronary syndrome (ACS)

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

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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".

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• Berlin Institut of Health (BIH), Germany: collaborator

Study Sites (3)

Charite University Campus Mitte

Berlin, 10117, Germany

Location

Charite University Campus Benjamin Franklin

Berlin, 12200, Germany

Location

Charite University Campus Virchow-Klinikum

Berlin, 13353, Germany

Location

Related Publications (2)

• 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.

  PMID: 37395586 DERIVED

• 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.

  PMID: 33080003 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood and coronary thrombus

MeSH Terms

Conditions

Acute Coronary Syndrome; ST Elevation Myocardial Infarction; Non-ST Elevated Myocardial Infarction; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• David M Leistner, MD

  Charite - University Medicine Berlin - Department for cardiology

  STUDY CHAIR

• Ulf Landmesser, MD

  Charite - University Medicine Berlin - Department for cardiology

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr. med.

Study Record Dates

• First Submitted: April 23, 2017
• First Posted: April 26, 2017
• Study Start: April 28, 2017
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: July 23, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3)