Myocardial Infarction Clinical Trial
— ODIPPOfficial 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
NCT number | NCT03342521 |
Other study ID # | 17-107 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 13, 2017 |
Est. completion date | December 31, 2018 |
Verified date | November 2017 |
Source | University Hospital, Caen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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
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 |
Country | Name | City | State |
---|---|---|---|
France | CAEN University Hospital | Caen |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Caen |
France,
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 |
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