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
  Purpose

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.


Condition Intervention Phase
Chest Pain
Acute Coronary Syndrome
Acute Myocardial Infarction
Coronary Artery Disease
Procedure: CT Coronary Angiography
Procedure: Traditional, Standard of Care
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: 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

Resource links provided by NLM:


Further study details as provided by American College of Radiology Imaging Network:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 1365
Study Start Date: July 2009
Estimated Study Completion Date: April 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00933400

Locations
United States, North Carolina
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
United States, Pennsylvania
Penn State Hershey - Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States, 19104
Penn-Presbyterian Medical Center
Philadelphia, Pennsylvania, United States, 19104
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
American College of Radiology Imaging Network
Pennsylvania Department of Health
Investigators
Study Chair: Harold I Litt, PhD University of Pennsylvania Health System
  More Information

Additional Information:
No publications provided by American College of Radiology Imaging Network

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: American College of Radiology Imaging Network
ClinicalTrials.gov Identifier: NCT00933400     History of Changes
Other Study ID Numbers: ACRIN PA 4005
Study First Received: July 2, 2009
Last Updated: March 13, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by American College of Radiology Imaging Network:
Computed Tomography
CTA
Cardiac CT
CT
Cardiac CTA
Chest Pain
Heart Attack
Emergency Department
Myocardial Infarction
Cost Effectiveness
Acute Coronary Event
Heart Imaging

Additional relevant MeSH terms:
Chest Pain
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Infarction
Myocardial Infarction
Acute Coronary Syndrome
Pain
Signs and Symptoms
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Ischemia
Pathologic Processes
Necrosis
Angina Pectoris

ClinicalTrials.gov processed this record on August 28, 2014