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Release of troponin evaluated by the peak of troponin during the hospital phase.Because of its sensitivity and specificity as well as its widespread use in routine practice, rise in troponin levels is the main assessment criteria of this study. We plan to demonstrate a significantly altered distribution of the troponin release as evaluated by the peak of troponin for each patient during the hospitalization period (from randomization to cardiologic unit discharge), in the two arms of the trial.
We propose to evaluate the optimal moment for catheterization in patients presenting with acute coronary syndromes by comparing rapid catheterization on the day of admission (within 8 hours of admission, with an average time close to 3 hours, as in the rapid strategy arm of the ISAR-COOL trial) with a slower approach where the examination is scheduled for the next working day (8 to 60 hours post admission, with an average close to 24 hours). Patients included will present with severe unstable angina defined as a TIMI score > 3 All patients must present with an indication for catheterization and they will receive the same optimal pharmacological treatment including abciximab (ReoPro*) when undergoing PCI and started just before the procedure as indicated in the label of the drug (substitution by another drug of the class, eptifibatide or tirofiban, is not possible in the catheterization laboratory according to the labels of these two other drugs). Randomization will evaluate only time to catheterization: rapidly, as soon as possible following admission (within 8 hours of admission) versus a delayed approach (8 to 60 hours following admission). The goal of randomization is to determine the ideal time to catheterization while indications for catheterization, pharmacological treatment, and patient care remain constant. This is a pragmatic study aiming to compare 2 different strategies in the management of ACS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2 | Active Comparator | Catheterization immediate PCI |
|
| 1 | Experimental | delayed PCI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Catheterization immediate PCI | Procedure | Catheterization immediate PCI |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Release of troponin evaluated by the peak of troponin during the hospital phase | during the hospital phase |
| Measure | Description | Time Frame |
|---|---|---|
| Death, MIs and urgent revascularizations will be recorded as ischemic events during 1month following randomization. | during 1month following randomization |
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Inclusion Criteria:
Man over 18 or non-pregnant woman over 18.
Patient hospitalized for severe acute coronary syndrome. To be selected patients will need to have at least 2 criteria for acute coronary syndrome AND a TIMI score > 3 for severity of ACS.
ACS is defined by at least two of the following diagnostic criteria :
Severity of ACS is defined by a TIMI score > 3
indication for catheterization agreed and possible within the following 8 hours.
signed consent form
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gilles MONTALESCOT, Professor | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut de Cardiologie - Hôpital Pitié-Salpétrière | Paris | 75013 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22795712 | Derived | Barthelemy O, Cayla G, Silvain J, O'Connor SA, Bellemain-Appaix A, Beygui F, Sideris G, Varenne O, Collet JP, Vicaut E, Montalescot G; ABOARD Investigators. Optimal time for catheterization in NSTE-ACS patients with impaired renal function: insights from the ABOARD Study. Int J Cardiol. 2013 Sep 10;167(6):2646-52. doi: 10.1016/j.ijcard.2012.06.126. Epub 2012 Jul 12. | |
| 19724041 |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| delayed PCI |
| Procedure |
delayed PCI |
|
| Montalescot G, Cayla G, Collet JP, Elhadad S, Beygui F, Le Breton H, Choussat R, Leclercq F, Silvain J, Duclos F, Aout M, Dubois-Rande JL, Barthelemy O, Ducrocq G, Bellemain-Appaix A, Payot L, Steg PG, Henry P, Spaulding C, Vicaut E; ABOARD Investigators. Immediate vs delayed intervention for acute coronary syndromes: a randomized clinical trial. JAMA. 2009 Sep 2;302(9):947-54. doi: 10.1001/jama.2009.1267. |