OPTMIZE-OSOptimization of Pre-surgical Testing With an Intensive Multifactorial Intervention to MinimiZe Cardiovascular Events in Orthopedic Surgery
Metoprolol
+ Lisinopril
+ Atorvastatin
Enfermedades Oclusivas Arteriales+14
+ Arteriosclerosis
+ Artritis
Estudio de Prevención
Resumen
Fecha de inicio: 1 de febrero de 2014
Fecha en la que se inscribió al primer participante.OPTIMIZE - OS (Optimization of Pre-surgical Testing with an Intensive Multifactorial Intervention to MinimiZe Cardiovascular Events - Orthopedic Surgery) trial is to determine the best management strategy for patients undergoing orthopedic surgery. OPTIMIZE will be a prospective randomized trial that will enroll patients during pre-surgical testing before orthopedic surgery. This trial will investigate different strategies aimed at lowering cardiovascular events following orthopedic surgery. The study will compare an intensive multifactorial intervention comprising behavioral modification and polypharmacologic therapy aimed at several modifiable risk factors versus usual care. The trial hypothesis is that a personalized optimization approach is superior to usual care in reducing a composite of death, myocardial infarction, stroke, transient ischemic attack, myocardial necrosis, venous thromboembolism or thrombosis requiring reoperation at 30-days. Secondary endpoints include length of stay, major bleeding, each individual endpoint from the primary endpoint, and quality of life.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 198 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Prevención
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.A partir de 21 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Inclusion Criteria: • ≥ 21 years of age Subjects undergoing open orthopedic surgery of the hip, knee or spine Surgery is scheduled at least 3 days after PAT visit and no more than 14 days. High risk subject cohort Coronary artery disease, or Cerebrovascular disease (prior stroke, TIA or carotid artery disease (>70% stenosis), or Peripheral artery disease, or Prior Venous thromboembolism or arterial thromboembolism, or Age ≥ 60 years and 2 of the following Renal insufficiency (creatinine clearance < 60ml/min) Diabetes COPD Hypertension Active smoker or stopped less than 30 days prior to consent Cancer (excluding BCC) Heart Failure Exclusion Criteria: • Known intolerance to statins Subject is already on maximum dose statin (atorvastatin/Lipitor 80mg daily or rosuvastatin/crestor 40mg daily) Bilateral renal artery stenosis End stage renal disease (receiving dialysis or CrCl <30ml/min) Known allergy or intolerance to ACE-inhibitor (other than cough) or Angiotensin receptor blocker (e.g. angioedema, hyperkalemia) Known allergy or intolerance to beta blockers Known sick sinus syndrome not treated with permanent pacemaker Known greater than first degree AV block not treated with a pacemaker Excessive alcohol intake Acute Coronary Syndrome requiring hospitalization within 1 month Stroke within 1 month Known pregnancy Severe co-morbid condition with life expectancy < 6 months Inability to give informed consent or adhere to follow-up as per protocol Current participation in another investigational drug or device trial
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.2 grupos de intervención están designados en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
Comparador ActivoGrupo II
Sin IntervenciónObjetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación
NYU Hospital for Joint Diseases
New York, United StatesAbrir NYU Hospital for Joint Diseases en Google Maps