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Clinical trials in peripheral vascular disease: pipeline and trial designs: an evaluation of the ClinicalTrials.gov database.
Subherwal, Sumeet; Patel, Manesh R; Chiswell, Karen; Tidemann-Miller, Beth A; Jones, W Schuyler; Conte, Michael S; White, Christopher J; Bhatt, Deepak L; Laird, John R; Hiatt, William R; Tasneem, Asba; Califf, Robert M.
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  • Subherwal S; From the Duke Clinical Research Institute, Duke University, Durham, NC (S.S., M.R.P., K.C., B.A.T.-M., W.S.J., A.T., R.M.C.); North Carolina State University, Raleigh (B.A.T.-M.); University of California, San Francisco, San Francisco (M.S.C.); Ochsner Heart & Vascular Institute, New Orleans, LA
  • Patel MR; From the Duke Clinical Research Institute, Duke University, Durham, NC (S.S., M.R.P., K.C., B.A.T.-M., W.S.J., A.T., R.M.C.); North Carolina State University, Raleigh (B.A.T.-M.); University of California, San Francisco, San Francisco (M.S.C.); Ochsner Heart & Vascular Institute, New Orleans, LA
  • Chiswell K; From the Duke Clinical Research Institute, Duke University, Durham, NC (S.S., M.R.P., K.C., B.A.T.-M., W.S.J., A.T., R.M.C.); North Carolina State University, Raleigh (B.A.T.-M.); University of California, San Francisco, San Francisco (M.S.C.); Ochsner Heart & Vascular Institute, New Orleans, LA
  • Tidemann-Miller BA; From the Duke Clinical Research Institute, Duke University, Durham, NC (S.S., M.R.P., K.C., B.A.T.-M., W.S.J., A.T., R.M.C.); North Carolina State University, Raleigh (B.A.T.-M.); University of California, San Francisco, San Francisco (M.S.C.); Ochsner Heart & Vascular Institute, New Orleans, LA
  • Jones WS; From the Duke Clinical Research Institute, Duke University, Durham, NC (S.S., M.R.P., K.C., B.A.T.-M., W.S.J., A.T., R.M.C.); North Carolina State University, Raleigh (B.A.T.-M.); University of California, San Francisco, San Francisco (M.S.C.); Ochsner Heart & Vascular Institute, New Orleans, LA
  • Conte MS; From the Duke Clinical Research Institute, Duke University, Durham, NC (S.S., M.R.P., K.C., B.A.T.-M., W.S.J., A.T., R.M.C.); North Carolina State University, Raleigh (B.A.T.-M.); University of California, San Francisco, San Francisco (M.S.C.); Ochsner Heart & Vascular Institute, New Orleans, LA
  • White CJ; From the Duke Clinical Research Institute, Duke University, Durham, NC (S.S., M.R.P., K.C., B.A.T.-M., W.S.J., A.T., R.M.C.); North Carolina State University, Raleigh (B.A.T.-M.); University of California, San Francisco, San Francisco (M.S.C.); Ochsner Heart & Vascular Institute, New Orleans, LA
  • Bhatt DL; From the Duke Clinical Research Institute, Duke University, Durham, NC (S.S., M.R.P., K.C., B.A.T.-M., W.S.J., A.T., R.M.C.); North Carolina State University, Raleigh (B.A.T.-M.); University of California, San Francisco, San Francisco (M.S.C.); Ochsner Heart & Vascular Institute, New Orleans, LA
  • Laird JR; From the Duke Clinical Research Institute, Duke University, Durham, NC (S.S., M.R.P., K.C., B.A.T.-M., W.S.J., A.T., R.M.C.); North Carolina State University, Raleigh (B.A.T.-M.); University of California, San Francisco, San Francisco (M.S.C.); Ochsner Heart & Vascular Institute, New Orleans, LA
  • Hiatt WR; From the Duke Clinical Research Institute, Duke University, Durham, NC (S.S., M.R.P., K.C., B.A.T.-M., W.S.J., A.T., R.M.C.); North Carolina State University, Raleigh (B.A.T.-M.); University of California, San Francisco, San Francisco (M.S.C.); Ochsner Heart & Vascular Institute, New Orleans, LA
  • Tasneem A; From the Duke Clinical Research Institute, Duke University, Durham, NC (S.S., M.R.P., K.C., B.A.T.-M., W.S.J., A.T., R.M.C.); North Carolina State University, Raleigh (B.A.T.-M.); University of California, San Francisco, San Francisco (M.S.C.); Ochsner Heart & Vascular Institute, New Orleans, LA
  • Califf RM; From the Duke Clinical Research Institute, Duke University, Durham, NC (S.S., M.R.P., K.C., B.A.T.-M., W.S.J., A.T., R.M.C.); North Carolina State University, Raleigh (B.A.T.-M.); University of California, San Francisco, San Francisco (M.S.C.); Ochsner Heart & Vascular Institute, New Orleans, LA
Circulation ; 130(20): 1812-9, 2014 Nov 11.
Article en En | MEDLINE | ID: mdl-25239436
ABSTRACT

BACKGROUND:

Tremendous advances have occurred in therapies for peripheral vascular disease (PVD); until recently, however, it has not been possible to examine the entire clinical trial portfolio of studies for the treatment of PVD (both arterial and venous disease). METHODS AND

RESULTS:

We examined interventional trials registered in ClinicalTrials.gov from October 2007 through September 2010 (n=40,970) and identified 676 (1.7%) PVD trials (n=493 arterial only, n=170 venous only, n=13 both arterial and venous). Most arterial studies investigated lower-extremity peripheral artery disease and acute stroke (35% and 24%, respectively), whereas most venous studies examined deep vein thrombosis/pulmonary embolus prevention (42%) or venous ulceration (25%). A placebo-controlled trial design was used in 27% of the PVD trials, and 4% of the PVD trials excluded patients >65 years of age. Enrollment in at least 1 US site decreased from 51% of trials in 2007 to 41% in 2010. Compared with noncardiology disciplines, PVD trials were more likely to be double-blinded, to investigate the use of devices and procedures, and to have industry sponsorship and assumed funding source, and they were less likely to investigate drug and behavioral therapies. Geographic access to PVD clinical trials within the United States is limited to primarily large metropolitan areas.

CONCLUSIONS:

PVD studies represent a small group of trials registered in ClinicalTrials.gov, despite the high prevalence of vascular disease in the general population. This low number, compounded by the decreasing number of PVD trials in the United States, is concerning and may limit the ability to inform current clinical practice of patients with PVD.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Ensayos Clínicos como Asunto / Bases de Datos Factuales / Enfermedades Vasculares Periféricas / Internet Tipo de estudio: Clinical_trials / Evaluation_studies / Prognostic_studies / Risk_factors_studies Límite: Humans País/Región como asunto: America do norte Idioma: En Revista: Circulation Año: 2014 Tipo del documento: Article País de afiliación: Laos Pais de publicación: EEUU / ESTADOS UNIDOS / ESTADOS UNIDOS DA AMERICA / EUA / UNITED STATES / UNITED STATES OF AMERICA / US / USA
Texto completo
Añadir a Mi BVS
Imprimir
XML
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Ensayos Clínicos como Asunto / Bases de Datos Factuales / Enfermedades Vasculares Periféricas / Internet Tipo de estudio: Clinical_trials / Evaluation_studies / Prognostic_studies / Risk_factors_studies Límite: Humans País/Región como asunto: America do norte Idioma: En Revista: Circulation Año: 2014 Tipo del documento: Article País de afiliación: Laos Pais de publicación: EEUU / ESTADOS UNIDOS / ESTADOS UNIDOS DA AMERICA / EUA / UNITED STATES / UNITED STATES OF AMERICA / US / USA