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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01734629
Pulmonary Disease in Patients Referred for Coronary CT
Pulmonary Disease in Patients Referred for Coronary CT and Association Between Spirometric Abnormalities and Coronary Calcium Score.
Several studies show an association between chronic obstructive pulmonary disease (COPD) and coronary artery disease (CAD). Besides risk factors such as smoking, both are associated with physical inactivity, advanced age and systemic inflammation The use of coronary computed tomography (CCT) with multiple detectors is a diagnostic method for coronary disease, describing the anatomy and severity of arterial obstruction. One way of estimating the cardiovascular risk is coronary calcium score (CCS). Due to the association between COPD and CAD, it is likely that many patients with IHD diagnosed by CT have reduced lung function.
The aim of this observational study is to establish the correlation between the CCS and lung function. It will also correlate the presence of irreversible airway obstruction with significant coronary lesions.
Patients over 40 years referred to CCT who agree to participate in the study will perform a spirometry with bronchodilator and collect a blood sample to measure serum markers of inflammation and cardiovascular risk (glycemia, lipid profile, C reactive protein (CRP), tumor necrosis factor-alpha (TNF-Alpha) and fibrinogen). The data will be compared in the general population and in subgroups: smokers, former smokers and nonsmokers.
One year after the CCT patients will be contacted by the investigators and accessed for emergency room visits, hospital admissions and fatal or nonfatal coronary or respiratory events.
The investigators hypothesis is that reduced lung function is independently associated with elevated CCS and is, also a risk factor for increased hospital admission and coronary events.
The concomitant assessment of lung function and CCS can contribute knowledge about the epidemiological association between pulmonary disease and CAD. This can also add to evidence for the use of spirometry as a marker of cardiovascular risk.
Descripción general del estudio
Estado
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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SP
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Sao Paulo, SP, Brasil, 05403-000
- Heart Institute (InCor) do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
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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 referred for coronary CT.
- Age greater than 40 years
Exclusion Criteria:
- History of myocardial revascularization (surgical or percutaneous)
- Cognitive-functional incapacity to perform spirometry
- Contraindication for administration of 400 mcg of albuterol
- Acute myocardial infarction or unstable angina within 2 weeks
- Angina pectoris class III or IV according to the Canadian Cardiovascular Society
- Heart failure New York Heart Association class III or IV
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
|---|
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Coronary CT Spirometry Cohort
Patients refereed to coronary CT enrolled in the study.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Coronary Calcium Score
Periodo de tiempo: Baseline
|
Coronary calcium score is a measurement obtained in coronary computer tomography.
The results will be compared between group with and without spirometric abnormalities.
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Baseline
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Coronary obstruction on CT
Periodo de tiempo: Baseline
|
Presence or absence of coronary obstruction and it´s quantification by Duke score will be compared between group with and without spirometric abnormality.
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Baseline
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Hospital Admissions
Periodo de tiempo: 1 year
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Hospital admissions will be accessed after one year from enrollment and compared between groups
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1 year
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ER visits
Periodo de tiempo: 1 year
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ER visits will be accessed after one year from enrollment and compared between groups
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1 year
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Fatal and non fatal cardiac or respiratory events
Periodo de tiempo: 1 year
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Fatal and non fatal cardiac or respiratory events will be accessed after one year from enrollment and compared between groups
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1 year
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Smoking Status
Periodo de tiempo: 1 year
|
All endpoints will be evaluated in smoking and nonsmoking subgroups.
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1 year
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Alberto Cukier, MD PHD, InCor - HCFMUSP
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2011/02814-0 FAPESP
- 0503/11 (Otro identificador: CAPPesq HCFMUSP)
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