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Related Concept Videos

Electrocardiogram01:29

Electrocardiogram

8.4K
An electrocardiogram (ECG or EKG) is a critical diagnostic tool that records the electrical signals produced by the heart during each heartbeat. This recording is achieved through electrodes placed strategically on the arms, legs, and chest. The electrocardiograph amplifies these signals and produces 12 distinct tracings, offering a comprehensive understanding of the heart's electrical activity.
Three major waveforms are present in a typical ECG recording: the P wave, the QRS complex, and...
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ECG Interpretation of Rhythms01:24

ECG Interpretation of Rhythms

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An electrocardiogram (ECG)graphically represents the heart's electrical activity on ECG paper or a monitor.
Components of the Electrocardiogram
The primary components of a normal ECG waveform in Normal sinus rhythm(NSR) include the P wave, PR interval, QRS complex, ST segment, T wave, and occasionally a U wave.
ECG waveforms are divided by vertical and horizontal lines at standard intervals.
The horizontal axis measures time and rate, and the vertical axis measures amplitude or voltage....
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Electrocardiogram Fundamentals01:28

Electrocardiogram Fundamentals

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Introduction
An electrocardiogram (ECG) is a diagnostic tool for identifying cardiac conditions such as arrhythmias, conduction abnormalities, and myocardial ischemia.
Definition
An electrocardiogram (ECG) visualizes the heart's electrical activity by tracing the electrical movement associated with each heartbeat on a graph or monitor. As the heart beats, an electrical wave passes through it, correlating with the cardiac cycle events.
Parts of an ECG
An ECG utilizes electrodes on the skin...
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Dysrhythmias V: Evaluating Dysrhythmias01:30

Dysrhythmias V: Evaluating Dysrhythmias

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Dysrhythmias, also known as arrhythmias, are disturbances in the heart's rhythm that range from benign to life-threatening. A thorough evaluation is crucial for appropriate management and involves a comprehensive medical history, physical examination, and various diagnostic tests.Medical HistorySymptoms: Collect detailed information on palpitations, dizziness, syncope, chest pain, and fatigue. Note their onset, frequency, and triggers.Previous Cardiac Issues: Document any history of heart...
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Correlation between ECG and Cardiac Cycle01:25

Correlation between ECG and Cardiac Cycle

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The electrical signals recorded on an electrocardiogram (ECG) occur before the mechanical processes of contraction and relaxation during the cardiac cycle.
A cardiac action potential originates in the SA node and spreads throughout the atria and the AV node in approximately 0.03 seconds. This results in the P wave in an ECG and triggers atrial contraction. The action potential is then briefly slowed at the AV node, allowing the atria to contract and fill the ventricles with blood before...
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Assessment of apical pulse01:17

Assessment of apical pulse

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Assessing the Apical Pulse
Assessing the apical pulse is a critical nursing procedure, particularly indicated for:
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How to Replace the TQT Study-The Use of Concentration-QTc Modeling to Exclude a Small Effect of a Novel Drug on QT Interval: Historical Perspective and Implementation.

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Thorough QT Study on the Effect of Therapeutic and Supratherapeutic Dosing of Givinostat in Healthy Volunteers.

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In Vivo Surface Electrocardiography for Adult Zebrafish
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Clinical ECG Assessment.

Borje Darpo1

  • 1Division of Cardiovascular Medicine, Department of Clinical Sciences, Karolinska Institutet, Danderyd's Hospital, Stockholm, Sweden, borje.darpo@telia.com.

Handbook of Experimental Pharmacology
|June 21, 2015
PubMed
Summary

The thorough QT/QTc (TQT) study assesses drug effects on ECGs, but resource-intensive. Early QT assessments in early development studies may replace TQT, optimizing resource use and providing confident data.

Area of Science:

  • Pharmacology
  • Clinical Trial Design
  • Cardiovascular Safety

Background:

  • The ICH E14 guidance mandates thorough QT/QTc (TQT) studies for new chemical entities (NCEs) to assess proarrhythmia risk.
  • Over 300 TQT studies conducted since 2005 have improved effectiveness and data confidence through regulatory interactions.
  • TQT studies are resource-intensive, solely focusing on NCEs' QTc interval prolongation.

Purpose of the Study:

  • To discuss technical features, design, and analysis of TQT studies.
  • To explore methods for demonstrating assay sensitivity and present recent study examples.
  • To address ECG assessment for drugs unsuitable for healthy volunteers, including tyrosine kinase inhibitors.

Main Methods:

  • Review of TQT study design, analysis, and assay sensitivity demonstration.

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  • Analysis of ECG data from studies in cancer patients and healthy volunteers with tyrosine kinase inhibitors.
  • Discussion of methods to enhance confidence in early QT assessments from single/multiple ascending dose studies.

    • Main Results:

    • TQT studies are performed effectively with high data confidence.
    • ECG assessments can be conducted in specific populations when healthy volunteers are unsuitable.
    • Early QT assessment methods show promise for replacing traditional TQT studies.

    Conclusions:

    • Optimizing human resource allocation by potentially replacing the TQT study with early QT assessments.
    • Developing approaches to increase confidence in ECG data from early development studies.
    • Outlining a pathway toward replacing the TQT study with validated early assessment methods.