Acute Myocardial Infraction/Hospitalized Angina or Chest Pain
AE / SAE Number
integer
Date of event
date
Estimated time of event
time
Was the subject hospitalized because of this event?
boolean
Date of Hospitalization
date
Time of Hospitalization
time
If Yes, was this event the primary reason for hospitalization?
boolean
If No, please specify primary reason for hospitalization:
text
AE/SAE Number
integer
Did the event occur during an ongoing hospitalization?
boolean
If Yes, please specify primary reason for hospitalization
text
AE/SAE Number
integer
if Yes, please complete the Death form
boolean
Do you consider that this event occurred as a direct consequence of any procedure/operation?
boolean
If Yes, please record AE/SAE Number
integer
Date of procedure/operation
date
Specify the procedure/operation
text
If Yes, please complete a Coronary Revascularization form
boolean
Clinical Presentation
Exercise related cardiac ischaemic-type chest pain/discomfort of new onset and duration of at least 10 minutes.
boolean
Exercise related cardiac ischaemic-type chest pain/discomfort increasing in frequency and/or severity and duration of at least 10 minutes.
boolean
Decreasing threshold for onset of exercise related cardiac ishaemic-type chest pain/discomfort.
boolean
Cardiac ischaemic-type chest pain/discomfort at rest
boolean
Severe, prolonged cardiac ischaemic-type chest pain or discomfort.
boolean
e.g., non-cardiac-type chest pain or discomfort
text
e.g., arm, throat or jaw pain/discomfort
text
Electrocardiographic Details
Were ECGs recorded in view of this event?
boolean
a. Are ECGs relating to this event (i.e during and/or after event) available?
text
record all dates here
integer
record all times here
time
if Yes, please ensure that you have provided copies of any ECG tracings that show these new changes.
boolean
New pathologic Q waves (or new R waves in V1 and V2) in 2 or more contiguous leads
boolean
If Yes, mark all that apply
text
If Other, specify
text
New ST segment elevation in 2 or more contiguous leads
boolean
If Yes, mark all that apply
text
Other, specify
text
New ST segment depression
boolean
If Yes, mark all that apply
text
Other, specify
text
New T wave changes
text
Other, specify
text
New left bundle branch block
boolean
Other new ECG changes
boolean
Other, specify
text
Cardiac Enzymes/Markers
CK-MB
Were the values taken?
boolean
Peak Value
text
Date sample taken
date
Time
time
Upper Limit of Normal
text
Enzyme Unit
text
Troponin I
Were the values taken?
boolean
Peak Value
text
Date sample taken
date
Time
time
Upper Limit of Normal
text
Enzyme Unit
text
Troponin T
Were the values taken?
text
Peak Value
text
Date sample taken
date
Time
time
Upper Limit of Normal
text
Enzyme Unit
text
Treatment Given for Acute MI/Hospitalized Angina/Chest Pain Event
check all that apply
text
If Primary or rescue percutaneous coronary intervention was prescribed, record the AE/SAE number:
integer
If Percutaneous coronary intervention for unstable angina was prescribed, record the AE/SAE number:
integer
For Other percutaneous coronary intervention record AE/SAE number
integer
Date
date
For Coronary bypass surgery record AE/SAE number
integer
For Other revascularisation procedure/operation/mechanical intervention specify the treatment type:
text
AE/SAE number
integer
Specify any additional therapies:
text
Other Investigations Undertaken in View of this Event
1. Was coronary angiography performed in view of this event?
boolean
Date of coronary angiography performed
date
Was invasive coronary angiography (i.e involving cardiac catheterization) performed?
boolean
Date of invasive coronary angiography performed
date
Was this reported to demonstrate angiographycally significant coronary artery disease thought to be responsible for the subject's presentation?
boolean
Was a stent previously placed prior to this hospitalization?
boolean
Was there evidence of stent thrombosis?
boolean
CT coronary angiography
boolean
Please submit a copy of the report, if available
date
Was this reported to demonstrate angiographically significant coronary artery disease thought to be responsible for the subject's presentation?
boolean
2. Was echocardiography performed in view of this event?
boolean
Date of echocardiography
date
Did this show evidence of a new regional wall motion abnormality?
boolean
If Yes, mark all that apply
text
If Other, specify
text
3. Was an exercise ECG test undertaken?
boolean
please submit a copy of the echocardiogram report, if available
date
Was the test positive for reversible myocardial ischaemia?
boolean
4. Was a stress myocardial perfusion scan undertaken?
boolean
please submit a copy of the stress myocardial perfusion scan report, if available
date
Test type
text
Was this test positive for reversible myocardial ischaemia?
boolean
5. Was any other investigation to test for the presence of reversible myocardial ischaemia undertaken (e.g. stress echocardiogram)?
boolean
Specify type of test
text
Please submit a copy of the other investigation report, if available
date
Was the test positive for reversible myocardial ischaemia?
boolean
Final Clinical Diagnosis
Was the final clinical diagnosis in relation to this event?
integer
mark one only
text
In case of other chest pain, specify
text
In case of other clinical diagnosis, specify
text
Narrative
include clinical presentation, treatment (including procedures or operations), results of investigations (e.g., ECGs and whether cardiac enzymes/biomarkers were elevated), and outcome, including autopsy if appropriate. Please provide sufficient information to allow the Endpoint Committee to accurately classify this event. A copy of the hospital discharge summary should be submitted.
text