CAEN University Hospital
Caen, 14000, France
NCT Number: NCT03342521
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:
1. 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 2. to confirm the impact of the residual mass measured by OCT on the EKG and angiographic myocardial reperfusion indices 3. identify patients with high thrombotic risk who may require more intensive antithrombotic therapy 4. identify simple biological markers associated with the residual mass measured by OCT
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Notify Me18 year and older
All sexes
Observational
Caen, 14000, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
optical coherence tomography Imaging P2Y12 and Aspirin reaction units quantification by the VerifyNow
Time frame: day 0
volume of the residual mass in mm3
Time frame: day 0
P2Y12 and aspirin reaction units, assessed by VerifyNow
Time frame: day 0
regression of ST-segment elevation >50% after angioplasty
Time frame: day 0
TIMI frame count (number) assessed after angioplasty
Time frame: day 0
Blush grade (from 0= no blush; 1=minimal; 2=moderate to 3= normal blush) assessed on angiography after angioplasty
Time frame: day 0
angiographic thrombus grade score (from 0=no thrombus to 5=occlusive thrombus)
Time frame: day 0
biological marker (µg/L)
Time frame: day 0
biological marker (in g/L)
Time frame: day 0
biological marker (in g/L)
University Hospital, Caen
Other
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
Acronym: ODIPP
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