Evidence map›Paper›PMID 29021091›Full record

ArticleJournal of electrocardiology

An evaluation of multiple algorithms for the measurement of the heart rate corrected JTpeak interval.

Jean-Philippe Couderc, Shiyang Ma, Alex Page, Connor Besaw, Jean Xia, W Brian Chiu, Johan de Bie, Jose Vicente, Martino Vaglio, Fabio Badilini and 3 more

Abstract read
In one paragraph

Article in Journal of electrocardiology. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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.

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

3 citing papers in PubMed.

  1. Review
  2. QT Assessment in Early Drug Development: The Long and the Short of It.International journal of molecular sciences · 2019
    Review
  3. Review
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

13 authors.

Jean-Philippe CoudercHeart Research Follow-up Program, University of Rochester Medical Center, Rochester, NY 14618, USA. Electronic address: heartjpc@heart.rochester.edu.
Shiyang MaDepartment of Biostatistics and Computational Biology, University of Rochester Medical Center, Rochester, NY 14618, USA.
Alex PageHeart Research Follow-up Program, University of Rochester Medical Center, Rochester, NY 14618, USA.
Connor BesawHeart Research Follow-up Program, University of Rochester Medical Center, Rochester, NY 14618, USA.
Jean XiaHeart Research Follow-up Program, University of Rochester Medical Center, Rochester, NY 14618, USA.
W Brian ChiuMortara Instrument Europe s.r.l., Via Cimarosa 103, 40033 Casalecchio di Reno, BO, Italy.
Johan de BieMortara Instrument Europe s.r.l., Via Cimarosa 103, 40033 Casalecchio di Reno, BO, Italy.
Jose VicenteDivision of Cardiovascular and Renal Products, Office of Drug Evaluation I, Office of New Drugs Center for Drug Evaluation and Research, U.S. Food and Drug Administration, USA.
Martino VaglioAMPS LLC, 418 Central Park W, Suite 21C, 10025 New York, NY, USA.
Fabio BadiliniAMPS LLC, 418 Central Park W, Suite 21C, 10025 New York, NY, USA.
Saeed BabaeizadehAdvanced Algorithm Research Center, Philips Healthcare, Andover, MA, USA.
Cheng-Hao Simon ChienAdvanced Algorithm Research Center, Philips Healthcare, Andover, MA, USA.
Mathias BaumertSchool of Electrical and Electronic Engineering, The University of Adelaide, SA 5005, Australia.

Funding

Center for Quantitative Electrocardiography and Cardiac SafetyU24HL096556 · NHLBI · UNIVERSITY OF ROCHESTER · PI COUDERC, JEAN-PHILIPPE Y · 2009 to 2011
$2.1M
NHLBI NIH HHS U24 HL096556
6 · The paper itself

Abstract

Interest in the effects of drugs on the heart rate-corrected JTpeak (JTpc) interval from the body-surface ECG has spawned an increasing number of scientific investigations in the field of regulatory sciences, and more specifically in the context of the Comprehensive in vitro Proarrhythmia Assay (CiPA) initiative. We conducted a novel initiative to evaluate the role of automatic JTpc measurement technologies by comparing their ability to distinguish multi- from single-channel blocking drugs. A set of 5232 ECGs was shared by the FDA (through the Telemetric and Holter ECG Warehouse) with 3 ECG device companies (AMPS, Mortara, and Philips). We evaluated the differences in drug-concentration effects on these measurements between the commercial and the FDA technologies. We provide a description of the drug-induced placebo-corrected changes from baseline for dofetilide, quinidine, ranolazine, and verapamil, and discuss the various differences across all technologies. The results revealed only small differences between measurement technologies evaluated in this study. It also confirms that, in this dataset, the JTpc interval distinguishes between multi- and single-channel (hERG) blocking drugs when evaluating the effects of dofetilide, quinidine, ranolazine, and verapamil. However, in the case of quinidine and dofetilide, we noticed a poor consistency across technologies because of the lack of standard definitions for the location of the peak of the T-wave (T-apex) when the T-wave morphology is abnormal.

Indexed as

AlgorithmsAdolescentAdultBiomarkersElectrocardiography, AmbulatoryHealthy VolunteersHeart Conduction SystemHumansIon ChannelsLong QT SyndromePhenethylaminesPotassium Channel BlockersQuinidineRanolazineSodium Channel BlockersSulfonamidesBiomarkersdofetilideIon ChannelsPhenethylaminesPotassium Channel BlockersQuinidineRanolazineSodium Channel BlockersSulfonamidesVerapamilCardiac safetyCiPAElectrocardiogramLong QT syndromeQTTorsade de pointes

Identifiers

PMID29021091
PMCPMC5699480

What OpenQuestion holds

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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.