Optimizing Infarct Size by Transforming Emergent Stenting Into an Elective Procedure Study (OPTIMASTRATEGY)
Immediate Versus Delayed Stenting in Patients With ST-Elevation Myocardial Infarction Undergoing Mechanical Intervention
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
In the setting of largely thrombotic lesions such as those treated in the context of primary PCI, stenting often results in distal micro and macro-embolisation which hampers coronary flow and microvascular recovery. Interestingly in some of these studies comparing BMS versus balloon angioplasty an early hazard associated to the use of stent has been reported.
Thus, investigators hypothesize in this protocol that refraining from stenting during the acute phase of ST segment myocardial infarction is safe and associated to improved myocardial recovery as compared to acute stenting.
Studietyp
Inskrivning (Förväntat)
Fas
- Fas 4
Kontakter och platser
Studieorter
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Emilia Romagna
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Ferrara, Emilia Romagna, Italien, 44100
- Rekrytering
- U.O. Cardiologia
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Kontakt:
- Alessandro Dal Monte, MD
- Telefonnummer: +39 3487243479
- E-post: dalmo_it@yahoo.it
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- chest pain for >30 min with ST-segment elevation of one mm or more in 2 or more contiguous ECG leads or with presumably new left bundle-branch block
- admission either within 12 h of symptom onset or between 12 and 24 h with evidence of continuing ischaemia
Exclusion Criteria:
- the exclusion criteria will include history of bleeding diathesis or documented allergy/intolerance or contraindication to clopidogrel or ticlopidine or prasugrel
- inability to assume an oral P2Y12 receptor blocker on a consecutive daily basis for a minimum of 6 months, or to heparin or aspirin
- uncontrolled hypertension (systolic or diastolic arterial pressure >180 mmHg or 120, respectively, despite medical therapy)
- limited life expectancy, e.g. neoplasms, others
- inability to obtain informed consent
- pregnancy
- patients were not enrolled if they were clinically unstable, presented with severe arrhythmia, or had known contraindications to CMR (claustrophobia, pacemakers, or implantable defibrillator devices)
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: Immediate stenting
Patients being randomized to the immediate stenting arm will be managed according to the guidelines.
Irrespective of TIMI flow at presentation, investigators will be requested to thrombus aspirate immediately after successful wiring of the culprit vessel followed by direct stenting.
In cases where insertion of thrombus removal catheter and/or direct stenting is not successful, balloon angioplasty will be allowed.
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Primary coronary stenting
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Experimentell: Delayed stenting
Patients being randomized to the delayed/staged stenting arm will be managed with the aim to obtain stable TIMI 3 flow with no considerations given at the percentage of residual stenosis at the culprit lesion. In patients presenting with TIMI 3 flow, investigators will be left free to wire the vessel and proceed to thrombus aspiration to decrease thrombus burden in the culprit lesion or to leave the vessel untreated at the time of index PCI. Patients presenting with suboptimal TIMI flow (i.e. less than 3), investigators are required to wire the vessel and thrombus aspirate. If stable (persisting for at least 5 minutes) TIMI 3 flow is obtained, investigators are requested to stop the procedure. The goal is to achieve s table TIMI 3 flow with no considerations given to the percentage of residual stenosis. Stenting in this arm will be allowed only on a bail-out strategy. |
Coronary stenting 3 to 7 days after having reopened the vessel in the acute phase
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Myocardial blush grade (MBG) equal or greater than 2
Tidsram: post-procedure
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The MBG will be estimated visually by 2 experienced observers, as previously described.
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post-procedure
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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ST segment elevation resolution
Tidsram: 30 minutes after the procedure
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Cumulative ST segment elevation in all leads will be quantified before and after the procedure and expressed as percentage
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30 minutes after the procedure
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ST segment elevation Resolution
Tidsram: 90 minutes after the procedure
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90 minutes after the procedure
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infarct size
Tidsram: 5 days
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Infarct size will be quantified by MRI
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5 days
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Infarct size
Tidsram: 6 months
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Infarct size will be quantified by MRI
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6 months
|
|
microvascular obstruction
Tidsram: 5 days
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microvascular obstruction will be quantified by MRI
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5 days
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microvascular obstruction
Tidsram: 6 months
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microvascular obstruction will be quantified by MRI
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6 months
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Mortality
Tidsram: 6 months
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overall and cardiac mortality will be assessed up to 6 months
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6 months
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Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- TRAPS-09-I
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