ODIPP: OFDI-Quantified Intracoronary Thrombus, Antiplatelet Pretreatment Effect and Myocardial Reperfusion

Sponsor

University Hospital, Caen (Other)

Overall Status

Completed

CT.gov ID

NCT03342521

Collaborator

(none)

Enrollment

Location

14.6

Actual Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Myocardial Infarction Thrombosis, Coronary	Diagnostic Test: optical coherence tomography and VerifyNow

Study Design

Study Type:

Observational

Actual Enrollment :

63 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

Oct 13, 2017

Actual Primary Completion Date :

Dec 31, 2018

Actual Study Completion Date :

Dec 31, 2018

Outcome Measures

Primary Outcome Measures

the volume of residual intrastent mass measured by OCT [day 0]
volume of the residual mass in mm3
the platelet reactivity assessed by VerifyNow [day 0]
P2Y12 and aspirin reaction units, assessed by VerifyNow

Secondary Outcome Measures

regression of EKG ST-segment elevation [day 0]
regression of ST-segment elevation >50% after angioplasty
Corrected Timi Frame count [day 0]
TIMI frame count (number) assessed after angioplasty
Myocardial blush grade [day 0]
Blush grade (from 0= no blush; 1=minimal; 2=moderate to 3= normal blush) assessed on angiography after angioplasty
angiographic pre-stenting thrombus grade [day 0]
angiographic thrombus grade score (from 0=no thrombus to 5=occlusive thrombus)
troponin [day 0]
biological marker (µg/L)
fibrinogen [day 0]
biological marker (in g/L)
albumin [day 0]
biological marker (in g/L)