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- Essai clinique NCT00351247
Postconditioning in Primary PCI and Direct Stenting
Clinical and MRI Evaluation of 2 Vs 4 Cycles of Postconditioning During Primary PCI With Direct Stenting
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Sample size: 45 subjects
Site Locations: Sheba medical center
Patients: Patients presenting with an acute MI with onset of symptoms 6h, and planned to undergo primary PCI will be included. The target lesion should be located in the proximal or middle segment of a main native coronary artery, and should be suitable for percutaneous intervention.
Primary Objective: To determine the safety and efficacy of 2 vs 4 cycles of postconditioning method during primary PCI and direct stenting in acute MI, and to compared to primary PCI and direct stenting without the postconditioning.
Primary Endpoint:
- ST segment resolution.
- Segmental wall motion score, resolution of edema and wall thickness by echocardiography.
- Infarct size estimation by cardiac enzymes and cardiac MRI.
Secondary endpoints:
- Composite endpoint of Major Adverse Cardiac Events (MACE) at 30 and 90 days
Methods:
- ECG at baseline, immediately after procedure, 90 and 180 minutes after the procedure and 6-24 hours after intervention.
- Core laboratory angiography measurements of TIMI flow, corrected TIMI Frame count, myocardial blush score and left ventricular angiography.
- Myocardial enzymes measurements: every 4 hours in the first 24 hours and every 6 hours in the following 48 hours.
- Left ventricular ejection fraction and wall motion score determined by echocardiography.
- Cardiac MRI estimation of infarct size. • Clinical follow-up at 30 and 90 days post procedure.
Follow-up:
- Follow up at 30 days: Clinical.
- Clinical Follow up & Cardiac MRI at 90 days.
Type d'étude
Inscription
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Tel Hashomer, Israël
- Sheba Medical Center
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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:
- Patient is > 21 years of age and provides informed consent.
- Evidence of AMI as indicated by signs and symptoms. Diagnosis of ST-segment elevation AMI will be based on chest pain for >30 minutes and ST-segment elevation of >1mV in 2 limb lead or >2mV in 2 anterior leads contiguous leads on the 12-lead ECG.
- Eligible to undergo primary PCI.
- Symptom duration is < 6 hours prior to primary PCI.
- Angiographic: The target lesion in the infarct related artery (IRA) should be occluded (TIMI).
- Angiographic: The target lesion in the proximal or middle segment of a native major coronary artery (LAD, RCA or dominant CX).
- Angiographic: The target lesion should be suitable for PTCA or stenting.
- Angiographic: The IRA occlusion will be successfully opened by stenting with TIMI 2-3
Exclusion Criteria:
- Unwillingness to participate.
- Prior Acute MI
- Cardiac arrest or Killip score III-IV
- Women with known pregnancy.
- Active significant bleeding.
- Known allergy for aspirin, ticlopidine and clopidogrel, or heparin.
- Chronic renal failure with creatinine > 2 mg/dl
- Other medical illness associated with limited life expectancy or that may cause the patient to be non-compliant with the protocol.
- Current participation in other trials using investigational drugs or devices.
- Contraindications to MRI including: arrythmias, cardiac pacer, brain aneurysm clips, cochlear implants, nerve stimulator.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
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ST segment resolution.
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Segmental wall motion score, resolution of edema and wall thickness by echocardiography.
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Infarct size estimation by cardiac enzymes and cardiac MRI.
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Mesures de résultats secondaires
Mesure des résultats |
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Composite endpoint of Major Adverse Cardiac Events (MACE) at 30 and 90 days
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Victor Guetta, MD, Sheba Medical Center
- Chercheur principal: Jonathan Leor, MD, Neufeld Cardiac Research Center
- Chercheur principal: Elad Maor, MD, Neufeld Cardiac Research Center
Publications et liens utiles
Publications générales
- Staat P, Rioufol G, Piot C, Cottin Y, Cung TT, L'Huillier I, Aupetit JF, Bonnefoy E, Finet G, Andre-Fouet X, Ovize M. Postconditioning the human heart. Circulation. 2005 Oct 4;112(14):2143-8. doi: 10.1161/CIRCULATIONAHA.105.558122. Epub 2005 Sep 26.
- Zhao ZQ, Corvera JS, Halkos ME, Kerendi F, Wang NP, Guyton RA, Vinten-Johansen J. Inhibition of myocardial injury by ischemic postconditioning during reperfusion: comparison with ischemic preconditioning. Am J Physiol Heart Circ Physiol. 2003 Aug;285(2):H579-88. doi: 10.1152/ajpheart.01064.2002. Erratum In: Am J Physiol Heart Circ Physiol. 2004 Jan;286(1):H477.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement de l'étude
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
- SHEBA-06-4066-VG-CTIL
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