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- Ensayo clínico NCT05149846
Pre-conditioning by Balloon-inflation on Myocardial Injury (BaMI)
Effect of Pre-conditioning by Balloon-inflation on Myocardial Injury During Complex Percutaneous Coronary Intervention - a Clinical Trial
Study objectives:
To test pre-conditioning by three consecutive 60 seconds balloon inflations, spaced 120 seconds apart, followed by 10 minutes rest prior to PCI reduces the risk of myocardial injury.
Study design:
Single-center, open-label, randomized controlled trial
Study population:
Patients with indication for complex PCI. Patients will be randomized prior to PCI to pre-conditioning by intracoronary balloon inflation in the target vessel proximal to the target lesion(s) versus no pre-conditioning followed by a 10-minute waiting period prior to PCI. PCI will then be performed as per standard of care. Cardiac biomarkers will be drawn at baseline and 6, 24 and 48 hours after PCI. Cardiac magnetic resonance imaging will be performed at 48 hours and 6 months post PCI.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The primary objective of this study is to test pre-conditioning by three consecutive 60 seconds balloon inflations, spaced 120 seconds apart followed by 10 minutes rest prior to percutaneous coronary intervention (PCI) reduces the risk of myocardial injury.
Except for the extended duration of balloon inflations, no study-specific therapy will be administered to the patients. All patients will receive treatment according to current guidelines. A follow-up visit will be performed at approximately 6, 24, 48 hours and at 6 months.
The population studied are patients with indication for complex PCI. Patients will be randomized, after providing written informed consent, prior to PCI to pre-conditioning by three consecutive intracoronary balloon inflation in the target vessel proximal to the target lesion(s) versus no pre-conditioning followed by a 10-minute waiting period prior to PCI, PCI will then be performed as per standard of care. Cardiac biomarkers will be drawn at baseline and 6 hours, 24 hours and 48 hours after PCI. Cardiac magnetic resonance imaging will be performed at 48 hours and 6 months post PCI.
Three consecutive balloon occlusions performed for approximate 60 seconds and spaced approximate 120 seconds apart, followed by a 10-minute waiting period prior to PCI.
Cardiac Magnetic Resonance imaging (CMR) will be used to assess size of myocardial infarction at 48±6 hours and 6 months±30 days post PCI. CMR examination includes administration of contrast and one additional blood test (hematocrit, necessary to assess extracellular volume).
Echocardiography can be used before randomization as per standard of care before PCI. Echocardiography will be used to assess wall motion score index, left ventricular ejection fraction at 24 hours and serial examinations can be performed at the discretion of the PI 12-lead Electrocardiogram (ECG) will be used to assess at baseline, during intervention, at 48 hours and serial examinations can be performed at the discretion of the PI.
Apart from the routine laboratory tests, blood samples (troponin-I, troponin-T, creatine kinase MB fraction [CKMB]) will be collected at baseline, 6±1 hour, 24±6 hours 48±6 hours after PCI. After collection blood samples will be analyzed at hospitals clinical laboratory and destructed directly after analyses.
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Margareta Scharin Täng, PhD
- Número de teléfono: +46 700207968
- Correo electrónico: margareta.scharin.tang@vgregion.se
Copia de seguridad de contactos de estudio
- Nombre: Björn Redfors, MD, PhD
- Número de teléfono: +46 31 3427543
- Correo electrónico: Bjorn.redfors@wlab.gu.se
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Age ≥18 years.
Indication for complex PCI, defined as:
- PCI of a chronic total occlusion
- Two-stent PCI of a bifurcation lesion.
- PCI of severely calcified lesion
- Preprocedural biomarker Troponin-I within normal range
- Left ventricular ejection fraction >50%
- Written informed consent obtained
Exclusion Criteria:
- Previous randomization in the study
- Decompensated heart failure requiring inotropic /adrenergic support, invasive or non-invasive ventilation or intra-aortic balloon pump/ventricular assist device therapy less than 48 hours prior to randomization
- Recent PCI (<3 months)
- Known previous myocardial infarction in the target vessel or regional wall motion abnormalities within the myocardium subtended by the target vessel(s)
- Any contraindication for Cardiac magnetic resonance imaging
- Pregnancy
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Otro: Pre-conditioning
Pre-conditioning by three consecutive 60 seconds balloon inflations, spaced 120 seconds apart followed by 10 minutes rest prior to PCI
|
Pre-conditioning by three consecutive 60 seconds balloon inflations, spaced 120 seconds apart followed by 10 minutes rest prior to PCI
|
Sin intervención: Controll
No pre-conditioning, standard care
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Cardiac troponin-I
Periodo de tiempo: within 48 hours
|
Area-under the curve of cardiac troponin-I
|
within 48 hours
|
Infarct size
Periodo de tiempo: 48 hours
|
Procedural infarct size as assessed by cardiac magnetic resonance imaging
|
48 hours
|
Infarct size
Periodo de tiempo: 6 months
|
Procedural infarct size as assessed by cardiac magnetic resonance imaging
|
6 months
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Björn Redfors, MD, PhD, Vastra Gotaland Region
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Anticipado)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
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
- BaMI
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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