PROTOCOL SPECIFIC MATERIALS Minimize
PROTOCOL ACRIN PA 4005

Randomized Controlled Study of a Rapid “Rule Out” Strategy 
Using CT Coronary Angiogram Versus Traditional Care for 
Low-Risk ED Patients with Potential Acute Coronary Syndromes

Note: Funded by the PA Department of Health and carried out by ACRIN PA Network institutions

Protocol Documents

Protocol-ACRIN PA 4005 Amendment 4 with Administrative Update, 3.9.11 [PDF]

SOC-ACRIN PA 4005 Amendment 4 with Administrative Update, 3.9.11 [PDF]

Informed Consent-ACRIN PA 4005 [DOC]

Principal Co-Investigators:  Harold I. Litt, MD, PhD, and Judd Hollander, MD

Status:  In Follow Up

Main Objective: The objective of this study is to estimate the rate of
major cardiac events (AMI or cardiac death) within 30 days in participants
randomized to CT coronary angiography (Group B) who were found not 
to have significant coronary artery disease on CT coronary angiography. 
“Significant” coronary artery disease is defined as great than or equal to 
50% stenosis of the left main, left anterior descending (LAD), left circumflex, 
right coronary artery (RCA), or their first order branches.

Participants: People 30 years and older who present to the ED with symptoms
consistent with potential ACS, TIMI Risk Scores between 0 and 2, and ECG without
acute ischemia.

Study Design Summary: A total of 1,365 participants will be recruited for this trial;
455 will be randomized to the traditional standard-of-care “rule out” treatment
and 910 will be randomized to the experimental “rule out” strategy of CT
coronary angiography.  Accrual will be accomplished in 24 months.