Evidence map›Paper›PMID 26961520›Full record

Trial reportJournal of the American Heart Association2016

Sample Size in Clinical Cardioprotection Trials Using Myocardial Salvage Index, Infarct Size, or Biochemical Markers as Endpoint.

Henrik Engblom, Einar Heiberg, David Erlinge, Svend Eggert Jensen, Jan Erik Nordrehaug, Jean-Luc Dubois-Randé, Sigrun Halvorsen, Pavel Hoffmann, Sasha Koul, Marcus Carlsson and 2 more

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of the American Heart Association, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03004703 (ASSessing the Effect of Anti-IL-6 Treatment in Myocardial Infarction), which is not on this map. Cited by 21 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 2 pooled it
–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.

NCT03004703 phase2completednot on this mapstarted 2017, after this paper: background citation

ASSessing the Effect of Anti-IL-6 Treatment in Myocardial Infarction: The ASSAIL-MI Trial

TypeinterventionalSponsorOslo University HospitalRan2017 to 2021Enrolled200ConditionsCoronary Disease, Myocardial InfarctionArmsTocilizumab, Sodium chloride 0.9%
3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
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  7. Article
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  11. Subacute cardiac rubidium-82 positron emission tomography (Journal of nuclear cardiology : official publication of the American Society of Nuclear Cardiology · 2018
    Article
  12. Review
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  18. Experimental validation of contrast-enhanced SSFP cine CMR for quantification of myocardium at risk in acute myocardial infarction.Journal of cardiovascular magnetic resonance : official journal of the Society for Cardiovascular Magnetic Resonance · 2017
    Article
  19. Article
  20. The severity of post-infarction edema suggests a bimodal pattern, whereas the extent does not.Journal of cardiovascular magnetic resonance : official journal of the Society for Cardiovascular Magnetic Resonance
    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

12 authors.

Henrik EngblomDepartment of Clinical Sciences Lund, Clinical Physiology, Skane University Hospital, Lund University, Lund, Sweden.
Einar HeibergDepartment of Clinical Sciences Lund, Clinical Physiology, Skane University Hospital, Lund University, Lund, Sweden Department of Biomedical Engineering, Faculty of Engineering, Lund University, Lund, Sweden.
David ErlingeDepartment of Cardiology, Skåne University Hospital and Lund University, Lund, Sweden.
Svend Eggert JensenDepartment of Cardiology, Aalborg University Hospital, Aalborg, Denmark.
Jan Erik NordrehaugDepartment of Clinical Science, University of Bergen, Norway.
Jean-Luc Dubois-RandéDepartment of Cardiology, Henri Mondor Hospital, Creteil, France.
Sigrun HalvorsenDepartment of Cardiology B, Oslo University Hospital Ullevål, University of Oslo, Norway Faculty of Medicine, University of Oslo, Norway.
Pavel HoffmannSection for Interventional Cardiology, Department of Cardiology, Oslo University Hospital, Ullevål, Norway.
Sasha KoulDepartment of Cardiology, Skåne University Hospital and Lund University, Lund, Sweden.
Marcus CarlssonDepartment of Clinical Sciences Lund, Clinical Physiology, Skane University Hospital, Lund University, Lund, Sweden.
Dan AtarDepartment of Cardiology B, Oslo University Hospital Ullevål, University of Oslo, Norway Faculty of Medicine, University of Oslo, Norway.
Håkan ArhedenDepartment of Clinical Sciences Lund, Clinical Physiology, Skane University Hospital, Lund University, Lund, Sweden hakan.arheden@med.lu.se.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCardiac magnetic resonance (CMR) can quantify myocardial infarct (MI) size and myocardium at risk (MaR), enabling assessment of myocardial salvage index (MSI). We assessed how MSI impacts the number of patients needed to reach statistical power in relation to MI size alone and levels of biochemical markers in clinical cardioprotection trials and how scan day affect sample size. METHODS AND

resultsControls (n=90) from the recent CHILL-MI and MITOCARE trials were included. MI size, MaR, and MSI were assessed from CMR. High-sensitivity troponin T (hsTnT) and creatine kinase isoenzyme MB (CKMB) levels were assessed in CHILL-MI patients (n=50). Utilizing distribution of these variables, 100 000 clinical trials were simulated for calculation of sample size required to reach sufficient power. For a treatment effect of 25% decrease in outcome variables, 50 patients were required in each arm using MSI compared to 93, 98, 120, 141, and 143 for MI size alone, hsTnT (area under the curve [AUC] and peak), and CKMB (AUC and peak) in order to reach a power of 90%. If average CMR scan day between treatment and control arms differed by 1 day, sample size needs to be increased by 54% (77 vs 50) to avoid scan day bias masking a treatment effect of 25%.

conclusionSample size in cardioprotection trials can be reduced 46% to 65% without compromising statistical power when using MSI by CMR as an outcome variable instead of MI size alone or biochemical markers. It is essential to ensure lack of bias in scan day between treatment and control arms to avoid compromising statistical power.

Indexed as

Magnetic Resonance ImagingSample SizeBiasBiomarkersComputer SimulationCreatine Kinase, MB FormEndpoint DeterminationHumansMyocardial InfarctionMyocardiumPercutaneous Coronary InterventionPredictive Value of TestsReperfusion InjuryReproducibility of ResultsTime FactorsTreatment OutcomeBiomarkersCreatine Kinase, MB FormTroponin Tacute myocardial infarctionbiochemical markerscardioprotectionmyocardial salvage indexsample size

Identifiers

PMID26961520
PMCPMC4943247

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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.