OFDI-Quantified Intracoronary Thrombus, Antiplatelet Pret... | NCT03342521

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

NCT03342521

Sponsor

University Hospital, Caen

Status

Completed

Last Update Posted

Apr 22, 2019Actual

Enrollment

63Actual

Phase

Not provided

Conditions

Myocardial Infarction
Thrombosis, Coronary

Interventions

optical coherence tomography and VerifyNow

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 13, 2017Actual

Primary Completion Date

Dec 31, 2018Actual

Completion Date

Dec 31, 2018Actual

First Submitted Date

Oct 19, 2017

First Submission Date that Met QC Criteria

Nov 13, 2017

First Posted Date

Nov 17, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 19, 2019

Last Update Posted Date

Apr 22, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

63Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
optical coherence tomography and VerifyNow	Diagnostic Test	optical coherence tomography Imaging P2Y12 and Aspirin reaction units quantification by the VerifyNow

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
vincent ROULE, MD	University Hospital, Caen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CAEN University Hospital		Caen		14000	France

Condition Browse Module

MeSH Terms

ID	Term
D009203	Myocardial Infarction
D003328	Coronary Thrombosis

Ancestor Terms

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D041623	Tomography, Optical Coherence

Ancestor Terms

ID	Term
D041622	Tomography, Optical
D061848	Optical Imaging
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures

Browse Leaves

Not provided

Browse Branches

Not provided