ACRIN 4005 Study

Penn State Milton S. Hershey Medical Center, Department of Emergency Medicine, in collaboration with the Penn State Heart and Vascular Institute and Penn State Department of Radiology will begin participation in ACRIN 4005 - A Randomized Controlled Study of a Rapid Rule out Strategy Using CT Coronary Angiogram versus Traditional Care for Low-to Intermediate Risk ED Patients with Potential Acute Coronary Syndromes.

In this study, eligible participants with potential ACS will be randomized to traditional rule out care (Group A) or a rapid rule out strategy comprising CT coronary angiography (Group B).  Patients, 30-80 years of age who present in the Emergency Department with a chief complaint consistent with potential ACS may be eligible for participation in this trial.  Participants must have initial ECG result without acute ischemia and a TIMI Risk Score of 0 to 2.

The potential benefits may include the ability for treating doctors to determine faster and accurately whether or not patients symptoms are related to heart. This may decrease both time and cost improving flow through the Emergency Department for low risk chest pain patients.

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. “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 older than 30 who present to the ED with symptoms consistent with potential ACS, TIMI Risk Scores between 0 and 2, ECG without acute ischemia, and normal cardiac troponin levels.

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. 

Study Principal Investigator:  Harold I. Litt, MD, PhD

Penn State Investigators:

  • Principal Investigator -  Harjit Singh, MD, Department of Radiology
  • coPrincipal Investigator - Steven Ettinger, MD, Heart and Vascular Institute
  • coPrincipal Investigator  - James M. Leaming, MD, Department of Emergency Medicine