Optical Coherence Tomography in Acute Coronary Syndrome

Acute Coronary Syndrome Clinical Trial

— OPTICO-ACS  

Official title:

Optical Coherence Tomography in Acute Coronary Syndrome

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03129503
• Other study ID #: 1.0
• Status: Active, not recruiting
• Start date: April 28, 2017
• Est. completion date: March 31, 2024

Study information

• Verified date: July 2019
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 with acute-coronary-syndrome (ACS).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 414
• Est. completion date: March 31, 2024
• Est. primary completion date: March 31, 2024
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Germany	Charite University Campus Benjamin Franklin	Berlin
Germany	Charite University Campus Mitte	Berlin
Germany	Charite University Campus Virchow-Klinikum	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Berlin Institut of Health (BIH), Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major adverse cardiovascular Events (MACCE)	powered	2 years after ACS
Secondary	Rehospitalization Rate for Angina pectoris		2 years after ACS
Secondary	Major adverse cardiovascular Events (MACCE)		30 days, 90 days, 12 months and 5 years after ACS
Secondary	Intima /media thickness	by sonography	Day 90 after ACS
Secondary	Global and regional left-ventricular systolic and diastolic function	by echocardiography	After ACS and 90 days after ACS
Secondary	Frequency and severity of angina	by Seattle Angina questionnaire	at day 90,12 and 24 months after ACS
Secondary	Pulse-wave-velocity (PWV), Augmentation index (AI) and Sub-endocardial Viability Ratio (SEVR).	by SphygmoCor system	Day 90 after ACS
Secondary	Lesion Coverage	by OCT	within 6 weeks to 3 months