CT Coronary Angiogram Versus Traditional Care in Emergency Department Assessment of Potential ACS

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by American College of Radiology Imaging Network.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Pennsylvania Department of Health
Information provided by (Responsible Party):
American College of Radiology Imaging Network
ClinicalTrials.gov Identifier:
NCT00933400
First received: July 2, 2009
Last updated: March 13, 2012
Last verified: March 2012

July 2, 2009
March 13, 2012
July 2009
February 2012   (final data collection date for primary outcome measure)
To estimate the rate of major cardiac events (AMI or cardiac death) within 30 days in participants in Group B who were found not to have stenosis of the main or first order coronary branches greater than or equal to 50% by CT coronary angiography. [ Time Frame: Within 30 days of discharge from the ED ] [ Designated as safety issue: Yes ]
To estimate the rate of major cardiac events (AMI or cardiac death) within 30 days in participants in Group B who were found not to have stenosis of the main or first order coronary branches greater than or equal to 50%. [ Time Frame: Within 30 days of discharge from the ED ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00933400 on ClinicalTrials.gov Archive Site
  • To estimate and compare the rates of significant CAD detected within the index visit in participants across the two study arms. [ Time Frame: 1-7 days, 30 days, and 1 year ] [ Designated as safety issue: Yes ]
  • To compare hospital length of stay across the two study groups. [ Time Frame: 1-7 days ] [ Designated as safety issue: No ]
  • To compare health care utilization and cost incurred by participants in the two study groups during the index hospitalization. [ Time Frame: 1-7 Days ] [ Designated as safety issue: No ]
  • To compare cardiac health care utilization and cost incurred by participants in the two study groups during 1 year post triage/presentation. [ Time Frame: Through 1-yr study follow up ] [ Designated as safety issue: No ]
  • To compare rates of major cardiac events (cardiac death, AMI, and revascularization for participants who were not found to have significant CAD at the index visit) among participants in the two study groups within 1 year post triage/presentation. [ Time Frame: Through 1-yr study follow up ] [ Designated as safety issue: Yes ]
  • To estimate and compare the rates of significant coronary artery disease detected within the index visit and subsequent workup, in participants across the two study arms. [ Time Frame: 1-7 days, 30 days, and 1 year ] [ Designated as safety issue: Yes ]
  • To compare hospital length of stay across the two study arms. [ Time Frame: 1-7 days ] [ Designated as safety issue: No ]
  • To compare health care utilization and cost incurred by participants in the two study groups during the index hospitalization. [ Time Frame: 1-7 Days ] [ Designated as safety issue: No ]
  • To compare cardiac health care utilization and cost incurred by participants in the two study groups during 1 year post randomization. [ Time Frame: Through 1-yr study follow up ] [ Designated as safety issue: No ]
  • To compare rates of major cardiac events (cardiac death, AMI, and revascularization for participants who were not found to have significant coronary disease at the index visit) among participants in the two study groups within 1 year post randomization. [ Time Frame: Through 1-yr study follow up ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
CT Coronary Angiogram Versus Traditional Care in Emergency Department Assessment of Potential ACS
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

This multi-center, randomized, controlled trial conducted in Emergency Departments (ED) compares computed tomography (CT) coronary angiography with the traditional approach (usual care) for low- to intermediate-risk chest pain patients. The primary objective is to estimate the rate of major cardiac events (heart attack or cardiac death) within 30 days in trial participants in Group B who were not found to have significant coronary artery disease by CT coronary angiography. Additional evaluations will comprise health care utilization assessments, including length of hospital stay and re-admissions, cost analysis, and 1-year post-triage/presentation major cardiac event rates.

In this study, participants with potential ACS will be randomized to traditional "rule out" care (Group A) or to traditional care plus CT coronary angiography (Group B) in a ratio of 1:2 traditional versus traditional plus CT coronary angiography.

In Group A, all management and disposition decisions will be made by the healthcare providers caring for the participant. Participants will be admitted to hospital, admitted to cardiac diagnostic unit, or discharged to home. Diagnostic testing and treatment will be decided by the team caring for the participant. Follow up will comprise telephone interviews after 30 days and 1 year from triage/presentation.

In Group B, participants will receive initial cardiac troponin and creatinine blood tests. Upon return of normal laboratory values, the participants will receive a CT coronary angiography an estimated 90 minutes after the initial values assessment or as soon as the CT scanner is available. Participants with negative test results will be discharged; follow up will comprise telephone interviews after 30 days and 1 year from triage/presentation. Participants with positive test results will be admitted to the hospital for further management dictated by the admitting team.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Chest Pain
  • Acute Coronary Syndrome
  • Acute Myocardial Infarction
  • Coronary Artery Disease
  • Procedure: CT Coronary Angiography
    CT coronary angiography will be performed without and with contrast in participants randomized to receive imaging as well as traditional care. (For applicable purposes, the decision to perform contrast-enhanced imaging in the presence of a large amount of calcium should be made according to procedures at each individual site.) The imaging test will be considered positive if the participant has a greater than 50% stenosis of the right coronary, left main, left anterior descending, or circumflex arteries or of their branches in contrast-enhanced CT coronary angiography. Results will be communicated to the responsible ED and treating staff immediately upon interpretation; ED staff will determine appropriate course of management. Negative results will result in patient discharge.
  • Procedure: Traditional, Standard of Care
    Participants randomized to traditional care will be assessed and discharged/treated according to routine standard-of-care procedures in the institution's emergency department.
  • Active Comparator: Traditional Strategy (Group A)
    In the traditional-care arm (Group A), all management and disposition decisions will be made by the healthcare providers caring for the participant. Participants will receive disposition (admit to hospital, admit to cardiac diagnostic unit, or discharge to home), diagnostic testing (none, stress testing, or cardiac catheterization), and treatment according to the team caring for the participant.
    Intervention: Procedure: Traditional, Standard of Care
  • Experimental: CT Coronary Angiography (Group B)
    In the study CT coronary angiography-based rapid "rule out" arm (Group B), participants will receive initial cardiac troponin and creatinine tests. Upon return of normal laboratory values (including a calculated creatinine clearance), the participants will receive a CT coronary angiography an estimated 90 minutes or as soon as the CT scanner is available following the initial values assessment. Participants with negative test results will be discharged unless other indications for admission per standard of care and follow up will comprise telephone interviews 30 days and 1 year after triage/presentation. Participants with positive test results will be admitted to the hospital for further management as dictated by the admitting team.
    Intervention: Procedure: CT Coronary Angiography
Litt HI, Gatsonis C, Snyder B, Singh H, Miller CD, Entrikin DW, Leaming JM, Gavin LJ, Pacella CB, Hollander JE. CT angiography for safe discharge of patients with possible acute coronary syndromes. N Engl J Med. 2012 Apr 12;366(15):1393-403. doi: 10.1056/NEJMoa1201163. Epub 2012 Mar 26.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1365
April 2012
February 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Participant is 30 years of age or older
  • Participant presents with complaints consistent with potential ACS (e.g., chest pain, shortness of breath, other)
  • Participant requires admission or objective testing to exclude ACS
  • Participant with initial ECG result without acute ischemia
  • Participant with an initial Thrombolysis in Myocardial Infarction (TIMI) Risk Score of 0 to 2
  • Participant is willing to provide a written informed consent

Exclusion Criteria:

  • Patients who present with symptoms that are clearly not cardiac in origin (e.g., chest pain secondary to herpes zoster, obvious pneumonia, or recent trauma);
  • Patients with no initial ECG performed in the ED
  • Patients with ST-elevation myocardial infarction (STEMI)
  • Patients with existing co-morbidity that requires admission regardless of presence of ACS (e.g., uncontrolled diabetes)
  • Patients with known contraindications to CT coronary angiography: Iodinated contrast allergic-like reaction
  • Patients who are known to have had CT coronary angiography in the year prior to presentation
  • Patients who are known to have normal catheterization results (no or minimal, < 25%, stenosis) in the year prior to presentation
  • Patients who are pregnant
  • Patients with known renal insufficiency (e.g., creatinine clearance < 60 mL/min/1.73 m2)
  • Patients with no telephone or cell phone numbers (preventing follow up)
  • Patients unwilling to provide a written informed consent
Both
30 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00933400
ACRIN PA 4005
Yes
American College of Radiology Imaging Network
American College of Radiology Imaging Network
Pennsylvania Department of Health
Study Chair: Harold I Litt, PhD University of Pennsylvania Health System
American College of Radiology Imaging Network
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP