- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02276781
BRAVO: Biomarker Risk Assessment in Vulnerable Outpatients (BRAVO)
The investigators hypothesize that among people with lower extremity peripheral artery disease (PAD), biomarker levels are higher during time periods immediately preceding an acute coronary event compared to time periods not immediately preceding an acute coronary event. Biomarkers the investigators will study are CRP, SAA, and D-dimer. Biomarkers will be measured at baseline and every two months during follow-up.
The primary aims of this study are as follows. Specific Aim #1. Among participants with PAD who experience an acute coronary event during follow-up, the investigators will determine whether biomarker levels measured immediately prior to the coronary event are higher than levels that do not immediately precede coronary events. Specific Aim #2, Part 1. The investigators will determine whether participants who experience a coronary event (cases) have higher biomarker levels at the visit immediately prior to the event than participants who have not experienced a coronary event (controls) at the time of the case event. Specific Aim #2, Part 2. The investigators will determine whether participants who experience a coronary event (cases) have a greater increase in biomarkers during the time period leading up to the event compared to participants who have not experienced a coronary event (controls).
To achieve these aims, the investigators will enroll up to 650 participants with PAD and follow them prospectively, measuring blood samples every two months, and ascertaining the presence of acute coronary events every two months.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Illinois
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Chicago, Illinois, Estados Unidos, 60637
- University of Chicago Medical Center
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Chicago, Illinois, Estados Unidos, 60611
- Northwestern University Feinberg School of Medicine
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Chicago, Illinois, Estados Unidos, 60612
- Rush Medical Center
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Chicago, Illinois, Estados Unidos, 60608
- Mt. Sinai Medical Center
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Chicago, Illinois, Estados Unidos, 60612
- Jesse Brown Veterans Administration Medical Center
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Chicago, Illinois, Estados Unidos, 60657
- St. Joseph's Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Peripheral arterial disease defined as an ABI less than or equal to 0.90 in either leg
We will also include PAD patients with an ABI > 0.90 who meet any of the following criteria:
- History of documented lower extremity revascularization. A written report from the medical record will be required as documentation
- An angiogram demonstrating >50% stenosis in one or more lower extremity arteries. Again, a written report will be required to document this. Participants with an angiogram noting moderate or greater stenosis will also be considered eligible, when a specific amount of stenosis is not denoted
- A report from the non-invasive vascular laboratory demonstrating a toe brachial pressure less than 0.60. Other criteria (i.e. PVR data) from the non-invasive vascular laboratory will not be considered sufficient for inclusion
Exclusion Criteria:
- Treatment for cancer other than non-melanoma skin cancer during the previous 2 years. (However, persons treated for non-invasive breast cancer or prostate cancer during the previous year will be potentially eligible if their physician indicates that their life expectancy is > 24 months, since non-invasive breast and prostate cancer often have an excellent prognosis)
- Unintentional weight loss of > 7.5 pounds in the last six months;
- Mini-Mental Status Exam (MMSE) score < 23 out of 30 or other history of cognitive impairment
- Communication difficulty due to language barriers
- Refusal to have regular blood draws or inability to obtain a blood sample at baseline
- Coronary or cerebrovascular event during the previous six months (these persons may become eligible at a later date)
- History of inflammatory arthritis (rheumatoid arthritis, lupus erythematosis, or polymyalgia rheumatic, gout), however participants with gouty arthritis will be eligible if the last episode was more than three months ago
- Residence more than 40 miles away from the medical center and unwillingness to travel to the medical center for every two month blood collection
- Unable to return for follow up testing for > a consecutive six month period in the next two years
- Heart transplant surgery
- Major surgery (one that required general anesthesia) within the past 3 months These persons may become eligible at a later date
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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PAD Participants
PAD participants from among consecutive patients with PAD identified from Chicago area non-invasive vascular laboratories
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
fatal and non-fatal coronary events
Periodo de tiempo: Every two months for up to three and a half years
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Our primary outcome is fatal and non-fatal coronary events.
Non-fatal coronary events will be defined as acute myocardial infarction (MI), hospitalizations for unstable angina, and new ECG findings consistent with MI
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Every two months for up to three and a half years
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Colaboradores e Investigadores
Patrocinador
Colaboradores
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
- R01HL089619 (Subvención/contrato del NIH de EE. UU.)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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