OPTICO-ACS: Optical Coherence Tomography in Acute Coronary Syndrome

Sponsor

Charite University, Berlin, Germany (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03129503

Collaborator

Berlin Institut of Health (BIH), Germany (Other)

414

Enrollment

Locations

83.1

Anticipated Duration (Months)

138

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Acute Coronary Syndrome STEMI - ST Elevation Myocardial Infarction NSTEMI - Non-ST Segment Elevation MI 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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

414 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Optical Coherence Tomography in Acute Coronary Syndrome

Actual Study Start Date :

Apr 28, 2017

Anticipated Primary Completion Date :

Mar 31, 2024

Anticipated Study Completion Date :

Mar 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Acute coronary syndrome (ACS) Patients with STE- or NSTE-ACS (acute coronary syndrome)

Outcome Measures

Primary Outcome Measures

Major adverse cardiovascular Events (MACCE) [2 years after ACS]
powered

Secondary Outcome Measures

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]
by sonography
Global and regional left-ventricular systolic and diastolic function [After ACS and 90 days after ACS]
by echocardiography
Frequency and severity of angina [at day 90,12 and 24 months after ACS]
by Seattle Angina questionnaire
Pulse-wave-velocity (PWV), Augmentation index (AI) and Sub-endocardial Viability Ratio (SEVR). [Day 90 after ACS]
by SphygmoCor system
Lesion Coverage [within 6 weeks to 3 months]
by OCT

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Inclusion Criteria:

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.

Exclusion Criteria:

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".
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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Charite University Campus Mitte	Berlin	Germany	10117
2	Charite University Campus Benjamin Franklin	Berlin	Germany	12200
3	Charite University Campus Virchow-Klinikum	Berlin	Germany	13353

Sponsors and Collaborators

Charite University, Berlin, Germany
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