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- Ensayo clínico 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
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Tel Hashomer, Israel
- Sheba Medical Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
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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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Medidas de resultado secundarias
Medida de resultado |
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Composite endpoint of Major Adverse Cardiac Events (MACE) at 30 and 90 days
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Victor Guetta, MD, Sheba Medical Center
- Investigador principal: Jonathan Leor, MD, Neufeld Cardiac Research Center
- Investigador principal: Elad Maor, MD, Neufeld Cardiac Research Center
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- SHEBA-06-4066-VG-CTIL
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