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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Anticipé)
Phase
- Phase 4
Contacts et emplacements
Lieux d'étude
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Emilia Romagna
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Ferrara, Emilia Romagna, Italie, 44100
- Recrutement
- U.O. Cardiologia
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Contact:
- Alessandro Dal Monte, MD
- Numéro de téléphone: +39 3487243479
- E-mail: dalmo_it@yahoo.it
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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)
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur actif: 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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Expérimental: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Myocardial blush grade (MBG) equal or greater than 2
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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ST segment elevation resolution
Délai: 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
Délai: 90 minutes after the procedure
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90 minutes after the procedure
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infarct size
Délai: 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
Délai: 6 months
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Infarct size will be quantified by MRI
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6 months
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microvascular obstruction
Délai: 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
Délai: 6 months
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microvascular obstruction will be quantified by MRI
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6 months
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Mortality
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- TRAPS-09-I
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