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

NCT ID: NCT03342521

Last Updated: 2019-04-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 63 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-10-13
• Study Completion Date: 2018-12-31

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

Conditions

Myocardial Infarction; Thrombosis, Coronary

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

optical coherence tomography and VerifyNow

optical coherence tomography Imaging P2Y12 and Aspirin reaction units quantification by the VerifyNow

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Caen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

vincent ROULE, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Caen

Locations

CAEN University Hospital

Caen, , France

Countries

France

Other Identifiers

17-107

Identifier Type: -

Identifier Source: org_study_id