- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00622024
Perioperative Depression and Postoperative Arrhythmia in Elective Coronary Bypass Graft Surgery
Postoperative arrhythmias (heart irregularities) are one of the most common complications after cardiac surgery and are associated with increased morbidity and mortality. Preoperative depression may be an important co-factor in the generation of postoperative arrhythmias due to sympathetic hyperactivity evident in patients with depression.
Objectives: To determine the effect of preoperative depression on postoperative arrhythmia in patients undergoing elective coronary artery bypass graft (CABG) surgery.
Prospective observational study, 120 patients undergoing elective CABG surgery ECG will be preformed preoperatively on all patients. All patients will be assessed for signs of depression using the Prime MD Patient Health Questionnaire (Prime MD PHQ) one week before surgery and 6 weeks postoperatively.Based on the Prime MD PHQ results, patients will be divided into two groups: those with or without signs of depression. Heart rate and rhythm monitoring with Holter will be performed for 3 days postoperatively in order to compare the incidence of postoperative arrhythmias between groups.
The primary outcome is the number of patients with and without depression suffering from ventricular and/or supraventricular arrhythmias. Secondary outcomes include all cause mortality, non-fatal myocardial infarction, cardiac arrest, and congestive heart failure.
CABG surgery is the most common operative procedure in North America and arrhythmias are one of the most common postoperative complication. It is estimated that about a third of these cardiac patients suffer from preoperative depression and therefore may be exposed to a higher risk of perioperative morbidity and mortality. If an association between preoperative depression and postoperative arrhythmia is found, treatment modalities may be indicated to reduce the prevalence of perioperative arrhythmia in patients with preoperative depression undergoing cardiac surgery.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Ontario
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Toronto, Ontario, Canadá, M5G 2C4
- Toronto General Hospital, UHN
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Patients between 18-75 years of age undergoing elective CABG surgery.
- Patients must provide informed consent
Exclusion Criteria:
- Patients with a history of arrhythmias (AF, supraventricular tachycardia, ventricular tachycardia, ventricular fibrillation, permanent pacemaker and/or defibrillator).
- Patients who are unable to read.
- Patients with significant psychiatric disorders other than depression.
- Patients with a history of pulmonary hypertension.
- Patients with a left ventricular ejection fraction < 40%.
- Patients with cognitive impairment as measured by the MMSE.
- Patients on antidepressants at the time of assessment
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Number of patients with and without depression suffering from ventricular and/or supraventricular arrhythmias
Periodo de tiempo: Depression assessment and holter monitor 3days postop
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Depression assessment and holter monitor 3days postop
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Rita Katznelson, MD, Toronto General Hospital, UHN
Publicaciones y enlaces útiles
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Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
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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
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Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- REB#06-0116-AE
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