Evidence map›Paper›PMID 27784272›Full record

Observational studyBMC nephrology2016

Rationale and study design of the prospective, longitudinal, observational cohort study "rISk strAtification in end-stage renal disease" (ISAR) study.

Christoph Schmaderer, Susanne Tholen, Anna-Lena Hasenau, Christine Hauser, Yana Suttmann, Siegfried Wassertheurer, Christopher C Mayer, Axel Bauer, Kostantinos D Rizas, Stephan Kemmner and 6 more

Registry-linked trialAbstract readObservational Study
In one paragraph

Observational study in BMC nephrology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01152892 (Risk Stratification in End Stage Renal Disease), which is not on this map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing 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.

NCT01152892 unknown statusnot on this map

Risk Stratification in End Stage Renal Disease (ISAR)

TypeobservationalSponsorTechnical University of MunichRan2010 to 2020Enrolled500ConditionsEnd Stage Renal Disease, Chronic Kidney Disease, Cardiovascular Event, Sudden Cardiac Death
3 · Its place in the literature

Who cites it

11 citing papers in PubMed.

  1. Observational
  2. Article
  3. Article
  4. Cognitive impairment and microvascular function in end-stage renal disease.International journal of methods in psychiatric research · 2022
    Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Observational
  10. Article
  11. 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

16 authors.

Christoph SchmadererDepartment of Nephrology, Klinikum rechts der Isar, Technische Universität München, Ismaninger Straße 22, 81675, Munich, Germany. christoph.schmaderer@mri.tum.de.
Susanne TholenDepartment of Nephrology, Klinikum rechts der Isar, Technische Universität München, Ismaninger Straße 22, 81675, Munich, Germany.
Anna-Lena HasenauDepartment of Nephrology, Klinikum rechts der Isar, Technische Universität München, Ismaninger Straße 22, 81675, Munich, Germany.
Christine HauserDepartment of Nephrology, Klinikum rechts der Isar, Technische Universität München, Ismaninger Straße 22, 81675, Munich, Germany.
Yana SuttmannDepartment of Nephrology, Klinikum rechts der Isar, Technische Universität München, Ismaninger Straße 22, 81675, Munich, Germany.
Siegfried WassertheurerHealth & Environment Department, AIT Austrian Institute of Technology GmbH, Biomedical Systems, Donau-City-Str. 1, 1220, Vienna, Austria.
Christopher C MayerHealth & Environment Department, AIT Austrian Institute of Technology GmbH, Biomedical Systems, Donau-City-Str. 1, 1220, Vienna, Austria.
Axel BauerMedizinische Klinik und Poliklinik I, Department of Cardiology, Klinikum Großhadern, Ludwig-Maximilians-Universität München, Marchioninistr. 15, 81377, Munich, Germany.
Kostantinos D RizasMedizinische Klinik und Poliklinik I, Department of Cardiology, Klinikum Großhadern, Ludwig-Maximilians-Universität München, Marchioninistr. 15, 81377, Munich, Germany.
Stephan KemmnerDepartment of Nephrology, Klinikum rechts der Isar, Technische Universität München, Ismaninger Straße 22, 81675, Munich, Germany.
Konstantin KotliarFH Aachen, University of applied sciences, Heinrich-Mussmann-Str. 1, 52428, Jülich, Germany.
Bernhard HallerInstitute of medical statistics and epidemiology (IMSE), Klinikum rechts der Isar, Technische Universität München, Ismaninger Straße 22, 81675, Munich, Germany.
Johannes MannStädtisches Klinikum Schwabing, KFH Dialysezentrum Schwabing, Kölner Platz 1, 80804, Munich, Germany.
Lutz RendersDepartment of Nephrology, Klinikum rechts der Isar, Technische Universität München, Ismaninger Straße 22, 81675, Munich, Germany.
Uwe HeemannDepartment of Nephrology, Klinikum rechts der Isar, Technische Universität München, Ismaninger Straße 22, 81675, Munich, Germany.
Marcus BaumannDepartment of Nephrology, Klinikum rechts der Isar, Technische Universität München, Ismaninger Straße 22, 81675, Munich, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe ISAR study is a prospective, longitudinal, observational cohort study to improve the cardiovascular risk stratification in endstage renal disease (ESRD). The major goal is to characterize the cardiovascular phenotype of the study subjects, namely alterations in micro- and macrocirculation and to determine autonomic function. METHODS/

designWe intend to recruit 500 prevalent dialysis patients in 17 centers in Munich and the surrounding area. Baseline examinations include: (1) biochemistry, (2) 24-h Holter Electrocardiography (ECG) recordings, (3) 24-h ambulatory blood pressure measurement (ABPM), (4) 24 h pulse wave analysis (PWA) and pulse wave velocity (PWV), (5) retinal vessel analysis (RVA) and (6) neurocognitive testing. After 24 months biochemistry and determination of single PWA, single PWV and neurocognitive testing are repeated. Patients will be followed up to 6 years for (1) hospitalizations, (2) cardiovascular and (3) non-cardiovascular events and (4) cardiovascular and (5) all-cause mortality. DISCUSSION/

conclusionWe aim to create a complex dataset to answer questions about the insufficiently understood pathophysiology leading to excessively high cardiovascular and non-cardiovascular mortality in dialysis patients. Finally we hope to improve cardiovascular risk stratification in comparison to the use of classical and non-classical (dialysis-associated) risk factors and other models of risk stratification in ESRD patients by building a multivariable Cox-Regression model using a combination of the parameters measured in the study. CLINICAL TRIALS IDENTIFIER: ClinicalTrials.gov NCT01152892 (June 28, 2010).

Indexed as

Research DesignCardiovascular DiseasesCause of DeathElectrocardiographyGastrointestinal DiseasesHospitalizationHumansInfectionsKidney Failure, ChronicLongitudinal StudiesLung DiseasesNeoplasmsNeuropsychological TestsPhenotypeProspective StudiesPulse Wave AnalysisAmbulatory blood pressure monitoring (ABPM)DialysisEnd stage renal diseaseHemodialysisISARMontreal Cognitive Assessment (MoCA)Pulse wave analysis (PWA)Pulse wave velocity (PWV)retinal vessel analysis (RVA)Risk stratification

Identifiers

PMID27784272
PMCPMC5080708

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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.