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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03342521
Acronym
ODIPP
Enrollment
63
Registered
2017-11-17
Start date
2017-10-13
Completion date
2018-12-31
Last updated
2019-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Infarction, Thrombosis, Coronary

Keywords

myocardial infarction, optical coherence tomography, intracoronary thrombus, VerifyNow

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

Interventions

DIAGNOSTIC_TESToptical coherence tomography and VerifyNow

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

Sponsors

University Hospital, Caen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
the volume of residual intrastent mass measured by OCTday 0volume of the residual mass in mm3
the platelet reactivity assessed by VerifyNowday 0P2Y12 and aspirin reaction units, assessed by VerifyNow

Secondary

MeasureTime frameDescription
Myocardial blush gradeday 0Blush grade (from 0= no blush; 1=minimal; 2=moderate to 3= normal blush) assessed on angiography after angioplasty
angiographic pre-stenting thrombus gradeday 0angiographic thrombus grade score (from 0=no thrombus to 5=occlusive thrombus)
regression of EKG ST-segment elevationday 0regression of ST-segment elevation \>50% after angioplasty
fibrinogenday 0biological marker (in g/L)
albuminday 0biological marker (in g/L)
troponinday 0biological marker (µg/L)
Corrected Timi Frame countday 0TIMI frame count (number) assessed after angioplasty

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026