Evidence map›Paper›PMID 26683627›Full record

Trial reportCardiovascular ultrasound2015

The value of core lab stress echocardiography interpretations: observations from the ISCHEMIA Trial.

Akihisa Kataoka, Marielle Scherrer-Crosbie, Roxy Senior, Gilbert Gosselin, Denis Phaneuf, Gabriela Guzman, Gian Perna, Alfonso Lara, Sasko Kedev, Andrea Mortara and 4 more

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Cardiovascular ultrasound, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01471522 (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches), which is not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
–field-weighted citation impact
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.

NCT01471522 nacompletednot on this map

International Study of Comparative Health Effectiveness With Medical and Invasive Approaches (ISCHEMIA)

TypeinterventionalSponsorNYU Langone HealthRan2012 to 2023Enrolled5,179ConditionsCardiovascular Diseases, Coronary Disease, Coronary Artery Disease, Heart DiseasesArmscardiac catheterization, coronary artery bypass graft surgery, percutaneous coronary intervention, Lifestyle, Medication
3 · Its place in the literature

Who cites it

9 citing papers in PubMed.

  1. Trial
  2. Observational
  3. Review
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Akihisa KataokaCardiac Ultrasound Laboratory, Massachusetts General Hospital and Harvard Medical School, 55 Fruit Street Yawkey 5E, Boston, MA, 02114, USA. kataoaki@sd5.so-net.ne.jp.
Marielle Scherrer-CrosbieCardiac Ultrasound Laboratory, Massachusetts General Hospital and Harvard Medical School, 55 Fruit Street Yawkey 5E, Boston, MA, 02114, USA. marielle@crosbie.com.
Roxy SeniorDepartment of Cardiovascular Medicine, Division of Cardiology, National Heart and Lung Institute, Imperial College, Sydney Street, London, SW3 6NP, UK. roxysenior@cardiac-research.org.
Gilbert GosselinDepartment of Medicine, Montreal Heart Institute, 5000 Belanger St, Montreal, QC H1T 1C8, Canada. g.gosselin@videotron.ca.
Denis PhaneufDepartment of Cardiology Research, CSSS du Sud de Lanaudiere, 911 Montee des Pionniers, Terrebonne, QC J6V 2H2, Canada. deniscphaneuf@hotmail.com.
Gabriela GuzmanDepartamento de Cardiologia, Hospital Universitario La Paz, Paseo de la Castellana, 261, Madrid, 28046, Spain. gabrielaguzman.ny@hotmail.com.
Gian PernaCardiologia Riabilitativa e Preventiva, Ospedali Riuniti of Ancona, via Conca 71, Ancona, Marche, 60020, Italy. gp.perna@ospedaliriuniti.marche.it.
Alfonso LaraHospital de Especialidades, Centro Medico Nacional 'La Raza', CRC IMSS, Gabriel Mancera 222 Col. del Valle, Benito Juarez, DF, 3100, Mexico. jorgeep@unam.mx.
Sasko KedevInterventional Cardiology, University Clinic of Cardiology, Vodnjanska 17, Skopje, Macedonia. skedev@mt.net.mk.
Andrea MortaraDepartment of Clinical Cardiology and Heart Failure, Policlinico de Monza, Via Amati 111, Monza, MB, 20900, Italy. andreamortara@libero.it.
Mohammad El-HajjarDivision of Cardiology, Internal Medicine, Albany Medical College and Stratton VA Medical Center, 47 New Scotland Ave. MC 44, Albany, NY, 12208, USA. el-hajm@mail.amc.edu.
Leslee J ShawDepartment of Medicine, Division of Cardiology, Emory University School of Medicine, 1462 Clifton Road, Atlanta, GA, 30322, USA. lshaw3@emory.edu.
Harmony R ReynoldsDepartment of Medicine, Division of Cardiology, New York University Langone Medical Center, 423 East 23rd Street 15150 N, New York, NY, 10010, USA. Harmony.Reynolds@nyumc.org.
Michael H PicardCardiac Ultrasound Laboratory, Massachusetts General Hospital and Harvard Medical School, 55 Fruit Street Yawkey 5E, Boston, MA, 02114, USA. MHPICARD@mgh.harvard.edu.

Funding

THE ISCHEMIA TRIAL - IICCU01HL105561 · NHLBI · WEILL MEDICAL COLL OF CORNELL UNIV · PI SHAW, LESLEE J · 2011 to 2018
$6.5M
NHLBI NIH HHS 1U01HL10556-01NHLBI NIH HHS 5U01HL105561-02NHLBI NIH HHS U01 HL105561
6 · The paper itself

Abstract

backgroundStress echocardiography (SE) is dependent on subjective interpretations. As a prelude to the International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) Trial, potential sites were required to submit two SE, one with moderate or severe left ventricular (LV) myocardial ischemia and one with mild ischemia. We evaluated the concordance of site and core lab interpretations.

methodsEighty-one SE were submitted from 41 international sites. Ischemia was classified by the number of new or worsening segmental LV wall motion abnormalities (WMA): none, mild (1 or 2) or moderate or severe (3 or more) by the sites and the core lab.

resultsCore lab classified 6 SE as no ischemia, 35 mild and 40 moderate or greater. There was agreement between the site and core in 66 of 81 total cases (81%, weighted kappa coefficient [K] =0.635). Agreement was similar for SE type - 24 of 30 exercise (80%, K = 0.571) vs. 41 of 49 pharmacologic (84%, K = 0.685). The agreement between poor or fair image quality (27 of 36 cases, 75%, K = 0.492) was not as good as for the good or excellent image quality cases (39 of 45 cases, 87%, K = 0.755). Differences in concordance were noted for degree of ischemia with the majority of discordant interpretations (87%) occurring in patients with no or mild LV myocardial ischemia.

conclusionsWhile site SE interpretations are largely concordant with core lab interpretations, this appears dependent on image quality and the extent of WMA. Thus core lab interpretations remain important in clinical trials where consistency of interpretation across a range of cases is critical.

trial registrationClinicalTrials.gov NCT01471522.

Indexed as

AgedClinical Laboratory TechniquesDiagnostic Tests, RoutineEchocardiography, StressFemaleHumansMaleMiddle AgedMyocardial IschemiaObserver VariationReproducibility of ResultsSensitivity and SpecificitySingle-Blind MethodVentricular Dysfunction, Left

Identifiers

PMID26683627
PMCPMC4683787

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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 OpenQuestion graph.