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

Myocardial Infarction Clinical Trial

— ODIPP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03342521
• Other study ID #: 17-107
• Status: Completed
• Start date: October 13, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: November 2017
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Thrombosis
• Infarction
• Myocardial Infarction
• Thrombosis
• Thrombosis, Coronary

Intervention

Diagnostic Test:
• optical coherence tomography and VerifyNow
optical coherence tomography Imaging P2Y12 and Aspirin reaction units quantification by the VerifyNow

Locations

Country	Name	City	State
France	CAEN University Hospital	Caen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the volume of residual intrastent mass measured by OCT	volume of the residual mass in mm3	day 0
Primary	the platelet reactivity assessed by VerifyNow	P2Y12 and aspirin reaction units, assessed by VerifyNow	day 0
Secondary	regression of EKG ST-segment elevation	regression of ST-segment elevation >50% after angioplasty	day 0
Secondary	Corrected Timi Frame count	TIMI frame count (number) assessed after angioplasty	day 0
Secondary	Myocardial blush grade	Blush grade (from 0= no blush; 1=minimal; 2=moderate to 3= normal blush) assessed on angiography after angioplasty	day 0
Secondary	angiographic pre-stenting thrombus grade	angiographic thrombus grade score (from 0=no thrombus to 5=occlusive thrombus)	day 0
Secondary	troponin	biological marker (µg/L)	day 0
Secondary	fibrinogen	biological marker (in g/L)	day 0
Secondary	albumin	biological marker (in g/L)	day 0