Evidence map›Paper›PMID 25239436›Full record

ArticleCirculation2014

Clinical trials in peripheral vascular disease: pipeline and trial designs: an evaluation of the ClinicalTrials.gov database.

Sumeet Subherwal, Manesh R Patel, Karen Chiswell, Beth A Tidemann-Miller, W Schuyler Jones, Michael S Conte, Christopher J White, Deepak L Bhatt, John R Laird, William R Hiatt and 2 more

Open access · bronzeAbstract readEvaluation Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Circulation, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 2 pooled it
5.6field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 2 syntheses or guidelines pooled it, 48 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors at 5 institutions in 1 country.

Sumeet SubherwalFrom 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 (C.J.W.); Brigham and Women's Hospital and Harvard Medical School, Boston, MA (D.L.B.); University of California, Davis, Sacramento (J.R.L.); and University of Colorado School of Medicine and CPC Clinical Research, Aurora (W.R.H.).
Manesh R PatelFrom 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 (C.J.W.); Brigham and Women's Hospital and Harvard Medical School, Boston, MA (D.L.B.); University of California, Davis, Sacramento (J.R.L.); and University of Colorado School of Medicine and CPC Clinical Research, Aurora (W.R.H.). manesh.patel@duke.edu.
Karen ChiswellFrom 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 (C.J.W.); Brigham and Women's Hospital and Harvard Medical School, Boston, MA (D.L.B.); University of California, Davis, Sacramento (J.R.L.); and University of Colorado School of Medicine and CPC Clinical Research, Aurora (W.R.H.).
Beth A Tidemann-MillerFrom 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 (C.J.W.); Brigham and Women's Hospital and Harvard Medical School, Boston, MA (D.L.B.); University of California, Davis, Sacramento (J.R.L.); and University of Colorado School of Medicine and CPC Clinical Research, Aurora (W.R.H.).
W Schuyler JonesFrom 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 (C.J.W.); Brigham and Women's Hospital and Harvard Medical School, Boston, MA (D.L.B.); University of California, Davis, Sacramento (J.R.L.); and University of Colorado School of Medicine and CPC Clinical Research, Aurora (W.R.H.).
Michael S ConteFrom 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 (C.J.W.); Brigham and Women's Hospital and Harvard Medical School, Boston, MA (D.L.B.); University of California, Davis, Sacramento (J.R.L.); and University of Colorado School of Medicine and CPC Clinical Research, Aurora (W.R.H.).
Christopher J WhiteFrom 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 (C.J.W.); Brigham and Women's Hospital and Harvard Medical School, Boston, MA (D.L.B.); University of California, Davis, Sacramento (J.R.L.); and University of Colorado School of Medicine and CPC Clinical Research, Aurora (W.R.H.).
Deepak L BhattFrom 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 (C.J.W.); Brigham and Women's Hospital and Harvard Medical School, Boston, MA (D.L.B.); University of California, Davis, Sacramento (J.R.L.); and University of Colorado School of Medicine and CPC Clinical Research, Aurora (W.R.H.).
John R LairdFrom 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 (C.J.W.); Brigham and Women's Hospital and Harvard Medical School, Boston, MA (D.L.B.); University of California, Davis, Sacramento (J.R.L.); and University of Colorado School of Medicine and CPC Clinical Research, Aurora (W.R.H.).
William R HiattFrom 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 (C.J.W.); Brigham and Women's Hospital and Harvard Medical School, Boston, MA (D.L.B.); University of California, Davis, Sacramento (J.R.L.); and University of Colorado School of Medicine and CPC Clinical Research, Aurora (W.R.H.).
Asba TasneemFrom 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 (C.J.W.); Brigham and Women's Hospital and Harvard Medical School, Boston, MA (D.L.B.); University of California, Davis, Sacramento (J.R.L.); and University of Colorado School of Medicine and CPC Clinical Research, Aurora (W.R.H.).
Robert M CaliffFrom 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 (C.J.W.); Brigham and Women's Hospital and Harvard Medical School, Boston, MA (D.L.B.); University of California, Davis, Sacramento (J.R.L.); and University of Colorado School of Medicine and CPC Clinical Research, Aurora (W.R.H.).
Harvard University · USUniversity of California, Davis · USUniversity of California, San Francisco · USBrigham and Women's Hospital · USNorth Carolina State University · US

Funding

Clinical Trials Transformation InitiativeU19FD003800 · FDA · DUKE UNIVERSITY · PI CALIFF, ROBERT · 2009 to 2013
$8.5M
Postdoctoral Training in Cardiovascular Clinical ResearchT32HL069749 · NHLBI · DUKE UNIVERSITY · PI MARK, DANIEL B · 2003 to 2023
$6.7M
Integrated Biostatistical Training for CVD ResearchT32HL079896 · NHLBI · NORTH CAROLINA STATE UNIVERSITY RALEIGH · PI Sean M O'Brien, Ana-Maria Staicu · 2006 to 2026
$4.1M
FDA HHS U19 FD003800NHLBI NIH HHS T32 HL069749NHLBI NIH HHS T32 HL079896
6 · The paper itself

Abstract

backgroundTremendous 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

resultsWe 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.

conclusionsPVD 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.

Indexed as

Databases, FactualInternetAmputation, SurgicalClinical Trials as TopicDevice ApprovalDouble-Blind MethodGeographic MappingHealth Services AccessibilityHumansPatient SelectionPeripheral Arterial DiseasePeripheral Vascular DiseasesPlacebosResearch DesignResearch Support as TopicStrokePlacebosclinical trials as topicperipheral vascular diseasesprevention and controlregistries

Identifiers

PMID25239436
PMCPMC4362518
OpenAlexW2137391829

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.