Evidence mapPaperPMID 20921541Full record

Trial reportAnnals of internal medicine2010

Multicenter validation of the diagnostic accuracy of a blood-based gene expression test for assessing obstructive coronary artery disease in nondiabetic patients.

Steven Rosenberg, Michael R Elashoff, Philip Beineke, Susan E Daniels, James A Wingrove, Whittemore G Tingley, Philip T Sager, Amy J Sehnert, May Yau, William E Kraus and 12 more

3 registry-linked trialsOpen access · greenAbstract readClinical TrialMulticenter StudyValidation Study
In one paragraph

Trial report in Annals of internal medicine, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 83 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
83citing papers in PubMed, 4 pooled it
16.4field-weighted citation impact, top 1% 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.

NCT01334684 naunknown statusstarted 2011, after this paper: background citation

White Blood Cells Gene Expression Profiles as a Tool for Predicting Metformin Efficacy in Patients With Type 2 Diabetes Mellitus

Ran2011Enrolled100Registered outcomes2Posted comparisons0ConditionsType 2 DiabetesArmsMetformin
Open the trial in the graph
NCT00500617 completednot on this map

Identification of Gene Expression Patterns in Circulating Cells That Predict the Presence of Coronary Artery Disease

TypeobservationalSponsorCardioDxRan2007 to 2011Enrolled4,350ConditionsCoronary Artery Disease, Angina Pectoris, Chest Pain, Cardiovascular DiseasesArmsCorus CAD (ASGES)
NCT05687578 enrolling by invitationnot on this mapstarted 2023, after this paper: background citation

A Prospective, Non-Randomized, Multi-Center Observational Study to Establish a Physical Baseline Profile for Individual Study Subjects Using Various Modalities and Identify Deviations Via Longitudinal Monitoring That May Develop Over Time

TypeobservationalSponsorPuer Research, LLCRan2023 to 2030Enrolled10,000ConditionsAgingArmsMeasurements Only
3 · Its place in the literature

Who cites it

83 citing papers in PubMed, 4 syntheses or guidelines pooled it, 177 citations in OpenAlex.

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  17. Gene Expression Signature in Patients With Symptomatic Peripheral Artery Disease.Arteriosclerosis, thrombosis, and vascular biology · 2021
    Article
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23 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

22 authors at 10 institutions in 1 country.

Steven RosenbergCardioDx, Palo Alto, California, USA.
Michael R Elashoff
Philip Beineke
Susan E Daniels
James A Wingrove
Whittemore G Tingley
Philip T Sager
Amy J Sehnert
May Yau
William E Kraus
L Kristin Newby
Robert S Schwartz
Szilard Voros
Stephen G Ellis
Naeem Tahirkheli
Ron Waksman
John McPherson
Alexandra Lansky
Mary E Winn
Nicholas J Schork
Eric J Topol
PREDICT (Personalized Risk Evaluation and Diagnosis in the Coronary Tree) Investigators
Minneapolis Heart Institute Foundation · USCardioDx (United States) · USArtemis (United States) · USDuke University · USGilead Sciences (United States) · USMedStar Washington Hospital Center · USPiedmont Atlanta Hospital · USScripps Research Institute · USUniversity of California, Los Angeles · USYale University · US

Funding

NCRR NIH HHS UL1 RR025774NCRR NIH HHS UL1RR025774
6 · The paper itself

Abstract

backgroundDiagnosing obstructive coronary artery disease (CAD) in at-risk patients can be challenging and typically requires both noninvasive imaging methods and coronary angiography, the gold standard. Previous studies have suggested that peripheral blood gene expression can indicate the presence of CAD.

objectiveTo validate a previously developed 23-gene, expression-based classification test for diagnosis of obstructive CAD in nondiabetic patients.

designMulticenter prospective trial with blood samples obtained before coronary angiography. (ClinicalTrials.gov registration number: NCT00500617)

setting39 centers in the United States. PATIENTS: An independent validation cohort of 526 nondiabetic patients with a clinical indication for coronary angiography. MEASUREMENTS: Receiver-operating characteristic (ROC) analysis of classifier score measured by real-time polymerase chain reaction, additivity to clinical factors, and reclassification of patient disease likelihood versus disease status defined by quantitative coronary angiography. Obstructive CAD was defined as 50% or greater stenosis in 1 or more major coronary arteries by quantitative coronary angiography.

resultsThe area under the ROC curve (AUC) was 0.70 ± 0.02 (P < 0.001); the test added to clinical variables (Diamond-Forrester method) (AUC, 0.72 with the test vs. 0.66 without; P = 0.003) and added somewhat to an expanded clinical model (AUC, 0.745 with the test vs. 0.732 without; P = 0.089). The test improved net reclassification over both the Diamond-Forrester method and the expanded clinical model (P < 0.001). At a score threshold that corresponded to a 20% likelihood of obstructive CAD (14.75), the sensitivity and specificity were 85% and 43% (yielding a negative predictive value of 83% and a positive predictive value of 46%), with 33% of patient scores below this threshold. LIMITATION: Patients with chronic inflammatory disorders, elevated levels of leukocytes or cardiac protein markers, or diabetes were excluded.

conclusionA noninvasive whole-blood test based on gene expression and demographic characteristics may be useful for assessing obstructive CAD in nondiabetic patients without known CAD. PRIMARY FUNDING SOURCE: CardioDx.

Indexed as

Gene ExpressionAdultAgedAged, 80 and overAge FactorsAlgorithmsArea Under CurveChest PainCoronary AngiographyCoronary Artery DiseaseDiabetes MellitusFemaleHumansMaleMiddle AgedProspective Studies

Identifiers

PMID20921541
PMCPMC3786733
OpenAlexW2117052877

What Socratic holds

Textmetadata
LicenceTDM
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Registered trials

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 Socratic graph.