Optical Frequency Domain Imaging-Quantified Intracoronary Thrombus Mass During Primary Percutaneous Coronary Intervention, Its Relationship With Antiplatelet Pretreatment Effect And Its Impact On Myocardial Reperfusion
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University Hospital, Caen
- Enrollment
- 63
- Locations
- 1
- Primary Endpoint
- the volume of residual intrastent mass measured by OCT
Study Overview
Brief Summary
The management of ST-elevation myocardial infarction in the acute phase requires an optimal antiaggregation combining aspirin and a P2Y12 inhibitor (clopidogrel, prasugrel or ticagrelor). Primary percutaneous coronary intervention must be performed within 2 hours of first medical contact. However, even with the new P2Y12 inhibitors, effective platelet inhibition which is required to inhibit the progression of intracoronary thrombus, is present only in half of the patients at 2 hours.
Optical coherence tomography (OCT) is the reference method for visualizing and quantifying intracoronary thrombus. The post-stenting intracoronary residual mass evaluated in OCT was associated with altered myocardial reperfusion indices, which were themselves associated with the prognosis of the patient. However, the determinants of this post-stenting residual mass -mostly thrombotic- remain unknown.
Measurement of platelet reactivity (expressed as P2Y12 Reaction Unit and Aspirin Reaction Unit) by simple turbidimetric tests (VerifyNow) is available in the cathlab. Enhanced platelet reactivity is reported in patients with acute coronary syndrome and represents a high-risk situation for recurrent coronary events in this setting.
The study aims to:
- to evaluate the relationship between the post-stenting residual intracoronary mass evaluated in OCT and the platelet response at the time of the PCI evaluated by Verify Now
- to confirm the impact of the residual mass measured by OCT on the EKG and angiographic myocardial reperfusion indices
- identify patients with high thrombotic risk who may require more intensive antithrombotic therapy
- identify simple biological markers associated with the residual mass measured by OCT
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •primary PCI with successful stenting for ST-elevation myocardial infarction
- •pretreated with ticagrelor, aspirin and enoxaparin
- •OCT and verifyNow performed in the acute phase
Exclusion Criteria
- •stent thrombosis
- •known coagulation disorder
- •clinical instability
- •pregnancy
Outcomes
Primary Outcomes
the volume of residual intrastent mass measured by OCT
Time Frame: day 0
volume of the residual mass in mm3
the platelet reactivity assessed by VerifyNow
Time Frame: day 0
P2Y12 and aspirin reaction units, assessed by VerifyNow
Secondary Outcomes
- fibrinogen(day 0)
- albumin(day 0)
- Corrected Timi Frame count(day 0)
- angiographic pre-stenting thrombus grade(day 0)
- regression of EKG ST-segment elevation(day 0)
- Myocardial blush grade(day 0)
- troponin(day 0)