ArticlePloS one2016
Automated Algorithm for J-Tpeak and Tpeak-Tend Assessment of Drug-Induced Proarrhythmia Risk.
Article in PloS one, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 17 papers.
What it found
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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.
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.
A Double-Blind, Randomized, Placebo-Controlled Single-Dose, Five Period Crossover Study of the Electrocardiographic Effects of Ranolazine, Dofetilide, Verapamil, and Quinidine in Healthy Subjects
Five Period Crossover Study of the Ability of Late Sodium or Calcium Current Block (Mexiletine, Lidocaine, or Diltiazem) to Balance the Electrocardiographic Effects of hERG Potassium Current Block (Dofetilide or Moxifloxacin)
Who cites it
17 citing papers in PubMed, 35 citations in OpenAlex.
- Effect of hyperglycaemia in combination with moxifloxacin on cardiac repolarization in male and female patients with type I diabetes.Clinical research in cardiology : official journal of the German Cardiac Society · 2022Trial
- Assessment of Multi-Ion Channel Block in a Phase I Randomized Study Design: Results of the CiPA Phase I ECG Biomarker Validation Study.Clinical pharmacology and therapeutics · 2019Trial
- Electrocardiographic Biomarkers for Detection of Drug-Induced Late Sodium Current Block.PloS one · 2016Trial
- Fast and accurate prediction of drug induced proarrhythmic risk with sex specific cardiac emulators.NPJ digital medicine · 2024Article
- QRS complex and T wave planarity for the efficacy prediction of automatic implantable defibrillators.Heart (British Cardiac Society) · 2024Article
- New science, drug regulation, and emergent public health issues: The work of FDA's division of applied regulatory science.Frontiers in medicine · 2022Review
- Measurement of Early and Late Repolarization Periods in Addition to QT Interval to Help Predict the Torsadogenic Risk of Donepezil Based on Reverse Translational Animal Research on Its Proarrhythmic Potential - Reply.Circulation reports · 2021Article
- Global electrical heterogeneity associated with drug-induced torsades de pointes.Heart rhythm · 2021Article
- Heart Rate Dependency and Inter-Lead Variability of the T Peak - T End Intervals.Frontiers in physiology · 2020Article
- Sex and race differences in J-Tend, J-Tpeak, and Tpeak-Tend intervals.Scientific reports · 2019Article
- Heart Rate Correction of the J-to-Tpeak Interval.Scientific reports · 2019Article
- Detection of T Wave Peak for Serial Comparisons of JTp Interval.Frontiers in physiology · 2019Article
- Comparison of Two Highly Automated ECG Algorithms for Detection of Drug-Induced Cardiac Ion Channel Block.Clinical pharmacology and therapeutics · 2018Article
- Translating New Science Into the Drug Review Process: The US FDA's Division of Applied Regulatory Science.Therapeutic innovation & regulatory science · 2018Article
- Mechanistic Model-Informed Proarrhythmic Risk Assessment of Drugs: Review of the "CiPA" Initiative and Design of a Prospective Clinical Validation Study.Clinical pharmacology and therapeutics · 2018Review
- Common Genetic Variant Risk Score Is Associated With Drug-Induced QT Prolongation and Torsade de Pointes Risk: A Pilot Study.Circulation · 2017Article
- An evaluation of multiple algorithms for the measurement of the heart rate corrected JTpeak interval.Journal of electrocardiologyArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundProlongation of the heart rate corrected QT (QTc) interval is a sensitive marker of torsade de pointes risk; however it is not specific as QTc prolonging drugs that block inward currents are often not associated with torsade. Recent work demonstrated that separate analysis of the heart rate corrected J-Tpeakc (J-Tpeakc) and Tpeak-Tend intervals can identify QTc prolonging drugs with inward current block and is being proposed as a part of a new cardiac safety paradigm for new drugs (the "CiPA" initiative).
methodsIn this work, we describe an automated measurement methodology for assessment of the J-Tpeakc and Tpeak-Tend intervals using the vector magnitude lead. The automated measurement methodology was developed using data from one clinical trial and was evaluated using independent data from a second clinical trial.
resultsComparison between the automated and the prior semi-automated measurements shows that the automated algorithm reproduces the semi-automated measurements with a mean difference of single-deltas <1 ms and no difference in intra-time point variability (p for all > 0.39). In addition, the time-profile of the baseline and placebo-adjusted changes are within 1 ms for 63% of the time-points (86% within 2 ms). Importantly, the automated results lead to the same conclusions about the electrophysiological mechanisms of the studied drugs.
conclusionsWe have developed an automated algorithm for assessment of J-Tpeakc and Tpeak-Tend intervals that can be applied in clinical drug trials. Under the CiPA initiative this ECG assessment would determine if there are unexpected ion channel effects in humans compared to preclinical studies. The algorithm is being released as open-source software.
trial registrationNCT02308748 and NCT01873950.
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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.