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

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

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

Study Overview

• Status: Completed
• Conditions: Myocardial Infarction; Thrombosis, Coronary
• Intervention / Treatment: Diagnostic test: optical coherence tomography and VerifyNow

• Study Type: Observational
• Enrollment (Actual): 63

Contacts and Locations

Study Locations

• France
  • Caen, France, 14000
    • Caen University hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the volume of residual intrastent mass measured by OCT	volume of the residual mass in mm3	day 0
the platelet reactivity assessed by VerifyNow	P2Y12 and aspirin reaction units, assessed by VerifyNow	day 0

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Caen
• Investigators: Principal Investigator: vincent ROULE, MD, University Hospital, Caen

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2017
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: October 19, 2017
• First Submitted That Met QC Criteria: November 13, 2017
• First Posted (Actual): November 17, 2017

Study Record Updates

• Last Update Posted (Actual): April 22, 2019
• Last Update Submitted That Met QC Criteria: April 19, 2019
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: myocardial infarction; optical coherence tomography; VerifyNow; intracoronary thrombus
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Coronary Disease; Myocardial Infarction; Infarction; Thrombosis; Coronary Thrombosis
• Other Study ID Numbers: 17-107

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No