Download Pulmonary Hypertension_FINAL_2-Dec-2013

PULMONARY HYPERTENSION
Protocol Identifier
Subject Identifier
Visit Description
Treatment Period
Visit XYZ
Upload the source documents for all data requested in this eCRF (e.g., labs, study results) as well as
the admission History and Physical Examination findings and the Discharge Summary.
HISTORY
[Y]
Shortness of breath
If Yes, record details below:
Mild
Yes [N]
No [NK]
Moderate
Not Known
Severe
Underlying disorder predisposing to pulmonary hypertension
Chronic obstructive pulmonary disease
[Y]
Yes [N]
No [NK]
Not Known
Mitral stenosis
[Y]
Yes [N]
No [NK]
Not Known
History of pulmonary emboli
[Y]
Yes [N]
No [NK]
Not Known
Current acute pulmonary emboli
[Y]
Yes [N] No [NK]
If Yes, complete the Deep Vein Thrombosis (DVT) Pulmonary Embolism (PE) from.
Not Known
History of medication know to cause pulmonary
hypertension (e.g., fenfluramine, amphetamine,
ergotamine)
[Y]
Yes [N]
No [NK]
Not Known
Other
[Y]
Yes [N]
No [NK]
Not Known
If Yes,
specify______________________________________________________________________________
PHYSICAL
Clinical signs of right ventricular hypertrophy
[Y]
Yes [N]
Blood pressure
CHEST X-RAY
Was a chest x-ray performed?
If Yes, complete the following:
N
/
[Y]
mmHg
Yes [N]
N
Date and time of chest x-ray
Day
Month
Year
Hrs:Mins
(00:00-23:59)
PULMONARY HYPERTENSION Page 1 of 4
PULMONARY HYPERTENSION
Protocol Identifier
Subject Identifier
Visit Description
Treatment Period
Visit XYZ
ECHOCARDIOGRAM
Was an Echocardiogram performed?
[Y]
Yes [N]
No [NK]
Not Known
If Yes, complete the following:
Date and time of
Echocardiography:
Day
Was echocardiography consistent with pulmonary
hypertension?
Month
[Y]
Year
Yes [N]
No [NK]
Hrs:Mins
(00:00-23:59)
Not Known
mmHg
Right ventricular systolic blood pressure
%
Left ventricular ejection fraction
VENTILATION/PERFUSION SCAN
Was a ventilation/perfusion scan performed?
[Y]
Yes [N]
No [NK]
Not Known
If Yes, complete the following:
Date and time of most recent
ventilation/perfusion scan:
Day
Was ventilation/perfusion consistent with
pulmonary hypertension?
Month
Year
Hrs:Mins
(00:00-23:59)
[Y]
Yes [N]
No [NK]
Not Known
Acute pulmonary embolism
[Y]
Yes [N]
No [NK]
Not Known
Acute massive pulmonary embolism
[Y]
Yes [N]
No [NK]
Not Known
Chronic pulmonary embolism syndrome
[Y]
Yes [N]
No [NK]
Not Known
[Y]
Yes [N]
No [NK]
Not Known
If Yes, complete the following:
PULMONARY FUNCTION TEST
Were pulmonary function tests performed?
If Yes, complete the following:
PULMONARY HYPERTENSION Page 2 of 4
PULMONARY HYPERTENSION
Protocol Identifier
Subject Identifier
Visit Description
Treatment Period
Visit XYZ
Date and time of Chest X-ray:
Day
Evidence of obstructive disease?
Evidence of restrictive disease?
Month
Year
Hrs:Mins
(00:00-23:59)
[Y]
Yes [N]
No [NK]
Not Known
[Y]
Yes [N]
No [NK]
Not Known
[Y]
Yes [N]
6 MINUTE WALK TEST
Was a 6 minute walk test performed?
No [NK]
Not Known
If Yes, complete the following:
Date and time of walk test:
Day
Month
Year
Total distance walked in 6 minutes
Hrs:Mins
(00:00-23:59)
meters
RIGHT HEART CATHETERIZATION
Was a right heart catheterization performed?
[Y]
Yes [N]
No [NK]
Not Known
Year
If Yes, complete the following:
Date and time of walk test:
Day
[Y]
Yes [N]
No [NK]
Hrs:Mins
(00:00-23:59)
Not Known
[Y]
Yes [N]
No [NK]
Not Known
Systolic (increased relative to normal pressure)
[Y]
Yes [N]
No [NK]
Not Known
Diastolic (increased relative to normal pressure)
[Y]
Yes [N]
No [NK]
Not Known
Mean ((increased relative to normal pressure)
[Y]
Yes [N]
No [NK]
Not Known
Was right heart catheterization consistent with
pulmonary hypertension?
Was pulmonary vascular resistance consistent with
pulmonary hypertension?
Month
If Yes, complete the following:
Pulmonary artery pressure:
PULMONARY HYPERTENSION Page 3 of 4
PULMONARY HYPERTENSION
Protocol Identifier
Subject Identifier
Visit Description
Treatment Period
Visit XYZ
Right ventricular systolic blood pressure
mmHg
Was left ventricular end diastolic pressure
increased?
[Y]
Yes [N]
No [NK]
Not Known
If Yes, complete the following:
Left ventricular end diastolic blood
mmHg
OTHER MEANS OF LEFT VENTRICULAR ASSESSMENTS
Was a study other than echocardiogram
performed that reported left ventricular
function?
[Y]
Yes [N]
No [NK]
Not Known
LEFT HEART CATHERIZATION
[Y]
Yes [N]
No [NK]
Not Known
If Yes, date and time of study:
Day
MUGA
[Y]
Yes [N]
Month
Year
No [NK]
Not Known
Month
Year
No [NK]
Not Known
Hrs:Mins
(00:00-23:59)
If Yes, date and time of study:
Day
MRI
[Y]
Yes [N]
Hrs:Mins
(00:00-23:59)
If Yes, date and time of study:
Day
Left ventricular end diastolic blood
Month
Year
Hrs:Mins
(00:0023:59)
mmHg
PULMONARY HYPERTENSION Page 4 of 4