ACRIN PA 4005 CRF COMPLETION INSTRUCTIONS
D1 Completion Instructions
The D1 form is essential to the 4005 study secondary endpoints for participant’s time accounted in the ED
and hospital. All time is to be documented in military/24 hr clock format. This form should be completed by
authorized RA’s or PI’s.
Note: These completion instructions only include questions that may need further clarification.
Question 1/1a:
Note: Not all sites have an Observation Unit specific for chest pain patients. All participants’ must have the
date and time they left ED regardless of disposition from the ED.
If the patient died in the ED or during visit one stay, record time and date of death on the DS (End of Study)
form.
Question 2/2a:
If participant was admitted to Observation Unit, select patient disposition from the unit. Also Document Date
and time (24 hr clock) participant was discharged from the unit.
Question 3/ 3a
If participant was admitted to the Hospital as an inpatient, select the unit where the patient was sent. Also
Document Date and time (24 hr clock) participant was discharged from the hospital.
This should be the time that the discharge order was written, not necessarily the time when the patient
subsequently left the hospital premises (as they could be waiting for a ride, etc.)
Question 4: What was the Primary Cardiac diagnosis for this visit?
Note: This question pertains to standardized cardiac diagnosis seen in the ED.
Refer to page 2 for definitions to the SAEM/ACEP/AHA and ACC standards of cardiac diagnosis.
A primary cardiac diagnosis must be determined at discharge for the index visit. If a cardiac diagnosis was
not recorded in the participant’s chart, consult with the treating ED physician or PI for clarification.
Chest pain NOS (not otherwise specified/studied) is a term used if a participant received no testing for
coronary disease, regardless of any other diagnosis given.
Question 4a: Select Other Diagnosis, not recorded above
Record all other diagnosis of cardiac or any non-cardiac diagnosis determined upon discharge.
The same diagnosis should not be marked in both Q4 (Primary diagnosis) and Q4a (Other diagnosis).
D1 Completion Instructions for v.1.0
01-26-2010
page 1 of 2
ACRIN PA 4005 CRF COMPLETION INSTRUCTIONS
Standardized Cardiac Diagnoses’ agreed upon by the SAEM/ACEP/AHA and ACC. (A Guide of
definitions)
AMI (Acute Myocardial Infarction)
Elevated cardiac troponin above lab threshold for normal (0.4) in setting of symptoms with or without
ECG changes
STEMI (ST segment elevation MI)
AMI subcategory where the patient has new ST segment elevation on the ECG at the time of
presentation to the ED (ECG impression of c/w AMI or ST elevation greater than 1mm on ECG form)
NSTEMI (non ST segment elevation MI)
AMI subcategory where the patient does NOT have ST segment elevation on the ECG at the time of
presentation to the ED (ECG impression of c/w AMI or ST elevation greater than 1mm on ECG form)
Unstable Angina (UA)
Stress test with reversible ischemia
o reversible perfusion defect on nuclear imaging;
o reversible wall motion abnormality on stress echocardiography
o or transient ECG changes alone, if no imaging performed
Cardiac catheterization with a lesion > 70%
CT Angiography with a lesion > 70%
Acute Coronary Syndrome (ACS)
Anyone with AMI (STEMI or NSTEMI) or UA
Stable Angina
Patients with known AMI, UA, ACS who have symptoms less severe than their typical regular
symptoms
Coronary Disease without ACS
Known disease from prior CABG (bypass), catheterization, coronary CTA, PCI without an evaluation
for ischemia (no stress, etc.) during this visit.
Known disease from prior CABG (bypass), catheterization, coronary CTA, PCI with a negative
evaluation for ischemia during this visit.
Had coronary CTA or catheterization with disease 50% to 69% during this visit without a positive
stress test (can be negative or not done).
Non-Ischemic Chest Pain/Symptoms
Stress test without reversible ischemia or transient ECG changes
Cardiac catheterization with the maximal lesion < 70%
CT Angiography with the maximal lesion < 70%
Chest Pain/Symptoms NOS (not otherwise specified/ studied)
Received no testing for coronary disease, regardless of other diagnosis given by the hospital team.
D1 Completion Instructions for v.1.0
01-26-2010
page 2 of 2