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In non-ST-elevation the optimal time of percutaneous coronary intervention (PCI) is unclear.
Some studies showed benefit of very early PCI, some others early PCI between 12-48 hours and others even showed a benefit of a selective invasive approach only in case of recurrence of symptoms or a positive stress test.
The optimal timing of intervention is still matter of debate as a result of a randomized clinical trial.
In this randomized, controlled, open-label clinical trial we compare a very early cardiac catheterization (< 2,5 hours after randomization) similar to ST-elevation myocardial infarction treatment, versus an early invasive approach (within 2-48 hours after randomization) versus a selective invasive approach in patients with non-ST-elevation myocardial infarction.
All patients are treated with heparin, ASA, Clopidogrel loading dose (600 mg) with subsequent 75 mg/d and tirofiban for 24 hours.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate Intervention | Active Comparator | Patients with NSTEMI undergo immediate invasive angiography (< 2 hours) |
|
| Early Intervention | Active Comparator | Patients with NSTEMI undergo early invasive angiography (12-48 hours) |
|
| Selective invasive angiography | Active Comparator | Patients with NSTEMI undergo selective invasive angiography |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Timing of percutaneous coronary intervention | Procedure | Immediate, early or selective invasive angiography |
|
| Measure | Description | Time Frame |
|---|---|---|
| peak creatine kinase- MB level | 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Major bleeding complications (GUSTO definition) | 30 days | |
| Composite: death, re-myocardial infarction, recurrent unstable angina | 6 months |
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Inclusion Criteria:
Clinical symptoms:
Instable angina pectoris:
Troponin T:
Troponin T-elevation ≥ 0,03 μg/l
Informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Holger Thiele | Heart Center Leipzig - University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum Links der Weser | Bremen | 28277 | Germany | |||
| Städt. Klinikum St. Georg |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22108830 | Derived | Thiele H, Rach J, Klein N, Pfeiffer D, Hartmann A, Hambrecht R, Sick P, Eitel I, Desch S, Schuler G; LIPSIA-NSTEMI Trial Group. Optimal timing of invasive angiography in stable non-ST-elevation myocardial infarction: the Leipzig Immediate versus early and late PercutaneouS coronary Intervention triAl in NSTEMI (LIPSIA-NSTEMI Trial). Eur Heart J. 2012 Aug;33(16):2035-43. doi: 10.1093/eurheartj/ehr418. Epub 2011 Nov 21. |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D000072658 | Non-ST Elevated Myocardial Infarction |
| D007238 | Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| Leipzig |
| 04129 |
| Germany |
| University of Leipzig - Heart Center | Leipzig | 04289 | Germany |
| University of Leipzig | Leipzig | 12103 | Germany |
| Krankenhaus der Barmherzigen BrĂ¼der | Regensburg | 93049 | Germany |
| D007511 |
| Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |