An observational study in Myocardial Infarction and Thrombosis, Coronary, sponsored by University Hospital, Caen. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-22.
Sponsored by University Hospital, Caen · Observational
Among 168 studies in Myocardial Infarction with a site in France — 22 open to participants now, 31 under way, 7 of them phase 3. Myocardial Infarction · France.
Among the 168 studies in Myocardial Infarction with a site in France, this one is the 47th largest by enrollment of the 54 observational ones that give a count, is one of 10 that started in 2017, is one of 54 observational ones, and was the 102nd registered.
2,270 studies on the registry are indexed under Myocardial Infarction; 371 are open to participants now.
Browse Myocardial Infarction studies →22 of the 168 studies in Myocardial Infarction with a site in France are open now. Recruiting first, the newest first:
University Hospital, Clermont-Ferrand · Sites in France
Ages 18–80
French Cardiology Society · Sites in France
Ages 18–60 · Women only
Centre Hospitalier Universitaire, Amiens · Sites in France
Ages 18+
CellProthera · Sites in France, United Kingdom
Ages 18+
University Hospital, Angers · Sites in France
Ages 18+
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 255 Myocardial Infarction studies recruiting now, 172 (67%) set no upper age limit and 26 (10%) stop at 75 or younger; 16 take children under 18; 27 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
168 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 14 · Phase 3 42 · Phase 4 14
First in 2002; this study’s year is marked. 10 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 63 is below the median of 568 across 814 observational studies indexed under Myocardial Infarction.
Median enrollment 332 across the 114 interventional studies, 756 across the 54 observational. Of the 124 that completed or were terminated, 24 (19%) have results posted.
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45 of 168 have an industry lead sponsor. The 10 most frequent:
University Hospital, Caen is the lead sponsor of 513 studies on the registry; 83 are open to participants now.
University Hospital, Caen has 5 studies filed under Myocardial Infarction — fewer than ten, so there is no comparison to draw.
8 of the studies in Myocardial Infarction with a site in France that are under way reach primary completion within a year, 4 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06118281Phase 3Novo Nordisk A/SARTEMIS - A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With a Heart Attack | 2027-01-29 |
| NCT05577988Phase 3Assistance Publique - Hôpitaux de ParisAssessment of an Early De-Escalation to a Low-potency Single Antiplatelet Therapy Guided by Genetics Versus a Systematic High-Potency Single Antiplatelet Therapy to Neutralize Bleeding Complications in Patients With High Bleeding Risk Beyond One Month After an Acute Coronary Syndrome | 2027-06 |
| NCT04957719Phase 3Viatris Innovation GmbHSelatogrel Outcome Study in Suspected Acute Myocardial Infarction | 2027-07 |
| NCT05476991Phase 3Assistance Publique - Hôpitaux de ParisEvaluation of Low Dose Colchicine and Ticagrelor in Prevention of Ischemic Stroke in Patients With Stroke Due to Atherosclerosis | 2027-09-01 |
| NCT02762162Action, FranceRegistry of Coronary Artery Ill Patients With Platelet Test Results | 2027-01 |
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Among the 168 studies in Myocardial Infarction with a site in France, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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:
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
optical coherence tomography Imaging P2Y12 and Aspirin reaction units quantification by the VerifyNow
the volume of residual intrastent mass measured by OCT
volume of the residual mass in mm3
Time frame: day 0
the platelet reactivity assessed by VerifyNow
P2Y12 and aspirin reaction units, assessed by VerifyNow
Time frame: day 0
regression of EKG ST-segment elevation
regression of ST-segment elevation \>50% after angioplasty
Time frame: day 0
Corrected Timi Frame count
TIMI frame count (number) assessed after angioplasty
Time frame: day 0
Myocardial blush grade
Blush grade (from 0= no blush; 1=minimal; 2=moderate to 3= normal blush) assessed on angiography after angioplasty
Time frame: day 0
angiographic pre-stenting thrombus grade
angiographic thrombus grade score (from 0=no thrombus to 5=occlusive thrombus)
Time frame: day 0
troponin
biological marker (µg/L)
Time frame: day 0
fibrinogen
biological marker (in g/L)
Time frame: day 0
albumin
biological marker (in g/L)
Time frame: day 0
Ran from Oct 2017 to primary completion in Dec 2018, 14 months.
Of 296 non-industry observational studies under Myocardial Infarction, half reached primary completion within 54 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 140. This study's 14 months is below that.
Counting every sponsor, half of 333 studies reached it within 48 months; a quarter within 17 and three quarters within 114.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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