Clinical trial NCT03342521: OFDI-Quantified Intracoronary Thrombus, Antiplatelet Pretreatment Effect and Myocardial Reperfusion
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocardial Infarction
Thrombosis, Coronary
Keywords: myocardial infarction
optical coherence tomography
intracoronary thrombus
VerifyNow
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2017-11-17
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients admitted in our hospital for primary PCI for ST-elevation myocardial infarction treated with successful stenting who had OCT and VerifyNow in the acute phase

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:

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


Eligibility criteria: 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

Primary outcomes:
measure: the volume of residual intrastent mass measured by OCT
timeFrame: day 0
measure: the platelet reactivity assessed by VerifyNow
timeFrame: day 0
Secondary outcomes:
measure: regression of EKG ST-segment elevation
timeFrame: day 0
measure: Corrected Timi Frame count
timeFrame: day 0
measure: Myocardial blush grade
timeFrame: day 0
measure: angiographic pre-stenting thrombus grade
timeFrame: day 0
measure: troponin
timeFrame: day 0
measure: fibrinogen
timeFrame: day 0
measure: albumin
timeFrame: day 0
Other outcomes:
Locations:
city: Caen
country: France
facility: CAEN University Hospital
Study officials:
affiliation: University Hospital, Caen
name: vincent ROULE, MD
role: PRINCIPAL_INVESTIGATOR
References: