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The EROSION - Effective Anti-thrombotic Therapy without Stenting - Intravascular Optical Coherence Tomography based on medical Management in Plaque Erosion

The EROSION (Effective Anti-thrombotic Therapy without Stenting: Intravascular OCT based Management in Plaque Erosion) II study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2019/10/021826
Enrollment
350
Registered
2019-10-31
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I222- Subsequent non-ST elevation (NSTEMI) myocardial infarction

Interventions

Intervention1: NIL: NIL

Sponsors

Stemi India
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Men or non-pregnant women >18 years of age and 2. Patients with NSTEMI will be included. NSTEMI will be defined as a progressive crescendo pattern of angina or angina at rest, in the absence of ST-segment elevation on the 12-lead ECG, with elevated cardiac markers. 3.Culprit lesion located in a native coronary artery 4.TIMI flow grade 3 and cross-sectional lumen area > 1.9 mm2 by OCT 5.Erosion defined by OCT 6.Patients able to provide written informed consent

Exclusion criteria

Exclusion criteria: 1. Known depressed left ventricular function (ejection fraction 2. Life expectancy 3.Contraindication to contrast media 4.Creatinine level > 2.0 mg/dL or end-stage kidney disease 5.Serious liver dysfunction 6.Patients with hemodynamic or electrical instability (including shock) 7.Any contraindication against the use of ticagrelor, tirofiban, aspirin, or heparin 8.Investigator considers the patient is not suitable

Design outcomes

Primary

MeasureTime frame
The primary endpoint for this study will be the thrombus burden at 1-month follow-up OCT. The OCT based detection and measurement of total thrombus burden, as measured by the volume of intracoronary thrombus, will be assessed by planimetry prior to PCI at baseline and at 1-month follow up. We hypothesize that at least 50% of the treated patients will show reduced thrombus burden by 50%Timepoint: 1 MONTH—

Secondary

MeasureTime frame
The secondary endpoints are (1) to prospectively study the incidence of plaque erosion by OCT in vivo in the Indian population, (2) to compare the incidence of more than 50% reduction in thrombus burden between the groups, (3) to establish CTA criteria equivalent to CSA of 1.9 mm2 on OCT, and (4) to discover biomarkers specific to plaque erosion.Timepoint: 1 month—

Countries

India

Contacts

Public ContactDr Ajit S Mullasari

Institute of Cardio Vascular Diseases

clireco@mmm.org.in919841271361

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026