Myocardial InfarctionODIPPNCT03342521
OFDI-Quantified Intracoronary Thrombus, Antiplatelet Pretreatment Effect and Myocardial Reperfusion
An observational study of Myocardial Infarction and Thrombosis, Coronary, run by University Hospital, Caen at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction, Thrombosis, Coronary
- What is being tested?
- optical coherence tomography and VerifyNow
- How many people
- 63 participants
- Where
- 1 siteFrance
- Study dates
- 13 Oct 2017to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older 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
Who may be able to join
- primary PCI with successful stenting for ST-elevation myocardial infarction
- pretreated with ticagrelor, aspirin and enoxaparin
- OCT and verifyNow performed in the acute phase
Who cannot join
- stent thrombosis
- known coagulation disorder
- clinical instability
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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
- Conditions
- Myocardial Infarction, Thrombosis, Coronary
- Being tested
- optical coherence tomography and VerifyNow
- Keywords
- myocardial infarction, optical coherence tomography, intracoronary thrombus, VerifyNow
- Medical subject headings
- Myocardial Infarction, Coronary Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
optical coherence tomography and VerifyNowDiagnostic test
optical coherence tomography Imaging P2Y12 and Aspirin reaction units quantification by the VerifyNow
What is being measured
The primary outcome is the main question the study is designed to answer.
the volume of residual intrastent mass measured by OCT
volume of the residual mass in mm3
Measured: day 0
the platelet reactivity assessed by VerifyNow
P2Y12 and aspirin reaction units, assessed by VerifyNow
Measured: day 0
Secondary outcomes (7)
regression of EKG ST-segment elevation
regression of ST-segment elevation >50% after angioplasty
Measured: day 0
Corrected Timi Frame count
TIMI frame count (number) assessed after angioplasty
Measured: day 0
Myocardial blush grade
Blush grade (from 0= no blush; 1=minimal; 2=moderate to 3= normal blush) assessed on angiography after angioplasty
Measured: day 0
angiographic pre-stenting thrombus grade
angiographic thrombus grade score (from 0=no thrombus to 5=occlusive thrombus)
Measured: day 0
troponin
biological marker (µg/L)
Measured: day 0
fibrinogen
biological marker (in g/L)
Measured: day 0
albumin
biological marker (in g/L)
Measured: day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start13 Oct 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- vincent ROULE, MD, Principal investigator, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03342521
- Sponsor's protocol ID
- 17-107
- Acronym
- ODIPP
- Status last verified
- Nov 2017
- First submitted
- 19 Oct 2017
- Last updated
- 22 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03342521
- Acronym / sponsor ID
- ODIPP / 17-107
- Conditions
- Myocardial Infarction, Thrombosis, Coronary
- Keywords
- myocardial infarction, optical coherence tomography, intracoronary thrombus, VerifyNow
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 13 Oct 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 17 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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
Key inclusion criteria (3 listed)
- primary PCI with successful stenting for ST-elevation myocardial infarction
- pretreated with ticagrelor, aspirin and enoxaparin
- OCT and verifyNow performed in the acute phase
Key exclusion criteria (4 listed)
- stent thrombosis
- known coagulation disorder
- clinical instability
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| optical coherence tomography and VerifyNowoptical coherence tomography Imaging P2Y12 and Aspirin reaction units quantification by the VerifyNow | Diagnostic test | – |
Primary outcome
the volume of residual intrastent mass measured by OCT
Time frame: day 0
volume of the residual mass in mm3
the platelet reactivity assessed by VerifyNow
Time frame: day 0
P2Y12 and aspirin reaction units, assessed by VerifyNow
7 secondary outcomes
regression of EKG ST-segment elevation
Time frame: day 0
Corrected Timi Frame count
Time frame: day 0
Myocardial blush grade
Time frame: day 0
angiographic pre-stenting thrombus grade
Time frame: day 0
troponin
Time frame: day 0
fibrinogen
Time frame: day 0
albumin
Time frame: day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
vincent ROULE, MD principal investigator
University Hospital, Caen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Infarction and Thrombosis, Coronary, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the volume of residual intrastent mass measured by OCT (time frame: day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2019.