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CLNE0019 - Experimental Neurology > ECG and Safety Biomarkers > Flashcards

ECG and Safety Biomarkers Flashcards

1
Q

What are the normal values for an adult resting heart rate?

A

60-100 bpm.

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2
Q

What is the normal value for the PR interval on an ECG?

A

0.12-0.2 seconds.

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3
Q

What is a normal value for the QRS complex on an ECG?

A

<0.12 seconds.

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4
Q

What is the normal QT interval for female patients on an ECG?

A

< half of RR
< 0.44 seconds

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5
Q

What is the normal QT interval for male patients on an ECG?

A

< half of RR
< 0.40 seconds

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6
Q

What does the large box represent on a standard ECG output?

A

Width = 0.2 seconds
Height = 0.5 mV amplitude

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7
Q

What does the small box represent on a standard ECG output?

A

Width = 0.04 seconds
Height = 0.1 mV amplitude

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8
Q

How do you calculate HR from an ECG?

A

Multiply the number of R waves in 10 seconds by 6 to get the number of beats per minute.

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9
Q

What are the vital signs monitored during a clinical trial?

A
  1. Heart rate (HR)
  2. Blood pressure (BP)
  3. Respiratory rate (RR)
  4. Body temperature
  5. Pulse oximetry
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10
Q

What is the normal blood pressure for an adult and when may this differ?

A

120/80 mmHg. This will increase in older patients as their blood vessels lose elasticity, leading to increased pressure in the vessels.

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11
Q

What does systolic pressure represent?

A

The maximum pressure recorded during contraction of the ventricles.

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12
Q

What does diastolic pressure represent?

A

The minimum pressure recorded during relaxation (prior to the next contraction of the ventricles).

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13
Q

What is a typical resting heart rate and when does this differ?

A

60-100 bpm. Young adults tend to have higher resting heart rates due to them having stronger adrenergic activity - this can also be visualised as a stronger wave on ECG. Neonates also have a much higher resting heart rate.

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14
Q

What is tachycardia?

A

A fast heart rate, typically > 100 bpm.

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15
Q

What is bradycardia?

A

A slow heart rate, typically <60 bpm.

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16
Q

What is a typical adult resting respiratory rate?

A

12-20 breaths per minute. This value can vary with age.

17
Q

What is pulse oximetry?

A

A measure of oxygen saturation in the blood which acts as a proxy for the amount of oxygen in the blood.

18
Q

What are normal values for pulse oximetry and when does this differ?

A

Healthy adults should have a value of 95-100. Adults with COPD may have a lower value due to blood being inadequately oxygenated due to the lung disease.

19
Q

What value on pulse oximetry is a cause for concern in healthy adults?

A

Below 95.

20
Q

What are common laboratory tests performed in clinical trials?

A
  1. Haematology
  2. Blood glucose
  3. Electrolytes
  4. Liver function test
  5. Lipids
  6. Creatine kinase
  7. Others including thyroid, amylase, troponin
21
Q

What is urinalysis used for?

A

To look at the composition of the urine and monitor for nephrotoxicity. Key things to check are blood, protein, glucose and infection.

22
Q

What does P represent on an ECG?

A

Depolarisation and contraction of the atria.

23
Q

What does the PR interval on an ECG represent?

A

The time taken from initiation of contraction of the atria to the end of the contraction
A delay may mean that blood is leaving the heart too slowly.

24
Q

What does the QRS interval on an ECG represent?

A

The time taken for the depolarisation and contraction of the ventricles. The amplitude of R gives the strength of the contraction.

25
Q

What does the T wave on an ECG represent?

A

The repolarisation and relaxation of the ventricles.

26
Q

What does the QT interval on an ECG represent?

A

The time period from the beginning of ventricular contraction to the time when it can begin again.

27
Q

What does the ST segment on an ECG represent?

A

The period in which the ventricles are not receptive to another electrical signal as they have not yet repolarised.
Extra systole occurs when there is an extra beat during this segment.

28
Q

What is pharmacovigilance?

A

Monitoring the safety aspects of a clinical trial to determine whether or not adverse events are deemed acceptable.

29
Q

Who is responsible for pharmacovigilance?

A

It is the ultimate responsibility of the Sponsor, but it can be delegated to a person, institution or research organisation.

30
Q

What is electrocardiography (ECG)?

A

ECGs are a recording of the electrical activity of the heart. They are useful for detecting conduction abnormalities.

31
Q

What are the 2 natural pacemakers in the heart?

A
  1. Sinoatrial node - input for contraction of the atria.
  2. Atrioventricular node - input for the contraction of the ventricles.
32
Q

What is the pattern of electrical activity in the heart?

A

Depolarisation is initiated in the SA node. There is slow conduction through the AV node then rapid conduction through Purkinje fibres.

33
Q

How many leads does a typical ECG have?

A

12 - 6 leads applied to the chest (in the direction of electrical activity) and 4 leads applied to the limbs.

34
Q
A
35
Q

How can you determine what region of the heart the abnormality is in?

A

Each ECG derivative is representative of a different view of the heart - if a beat is abnormal in one derivative but not in the others, that is the region where the issue is.

36
Q

What is seen on an ECG in atrial fibrillation?

A
  1. An atrial rate of 400-650 bpm.
  2. A lack of P wave (QRS is normal).
  3. A wandering baseline.
  4. Irregularly irregular rhythm.
37
Q

What is seen on an ECG in a myocardial infarction or ischaemia?

A
  1. Abnormalities in the ST segment or T wave.
  2. ST elevation - the ST segment will not fall on the iso-electric line.
38
Q

What is a prolonged QT interval and what is it associated with?

A

A QT interval > 0.44 sec in males and > 0.46 sec in females is a marker of myocardial electrical instability. This is associated with ventricular arrhythmia, syncope and sudden death.
At > 0.5 sec, there is a risk of Torsade des Pointes which can escalate to VF and death.

CLNE0019 - Experimental Neurology (6 decks)

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