Computed Tomography Coronary Angiogram (CTCA) Versus Traditional Care in Emergency Department Assessment of Potential Acute Coronary Syndromes (ACS)

NCT00933400 | Completed Results DMC

• 1 other identifier: ACRIN PA 4005
• Study Type: interventional
• Target: 1,392
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Chest Pain; Acute Coronary Syndrome; Acute Myocardial Infarction; Coronary Artery Disease

Keywords

Computed Tomography; CT Angiography (CTA); Cardiac CT; CT; Cardiac CTA (CCTA); Chest Pain; Heart Attack; Emergency Department; Myocardial Infarction; Cost Effectiveness; Acute Coronary Event; Heart Imaging

Outcome Measures

Primary Outcomes (1)

• Rates of Major Cardiac Events (AMI or Cardiac Death) Within 30 Days

  To estimate the rate of major cardiac events (AMI or cardiac death) within 30 days of discharge from Emergency Department (ED) - patient follow-up included telephone interviews 30 days and 1 year after triage/presentation. 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 were considered negative and considered discharged if they were not designated to receive an inpatient bed or formal observation status. All myocardial infarctions were reviewed by an Adjudication Committee to confirm diagnosis.

  up to 30 days of discharge from the ED

Secondary Outcomes (5)

• Significant Coronary Artery Disease Detected Within Index Hospitalization as Assessed by Medical Record Review.

  baseline

• Mean Length of Hospital Stay After Initial Visit

  1-7 days

• Health Care Utilization During the Index Hospitalization.

  1-7 Days

• Cardiac Health Care Utilization 1 Year Post Triage/Presentation.

  Through 1-yr study follow up

• Major Adverse Cardiac Event (MACE, Including Myocardial Infarction & Cardiac Death) and Revascularization for Participants Within 1 Year Post Triage/Presentation

  Through 1-yr study follow up

Study Arms (2)

Traditional Strategy [Group A]

ACTIVE COMPARATOR

In the traditional-care arm (Group A:Standard of Care (SOC)), 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 Strategy

CT Coronary Angiography (CTCA)[Group B]

EXPERIMENTAL

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.

Diagnostic Test: CT Coronary Angiography (CTCA)

Interventions

CT Coronary Angiography (CTCA) DIAGNOSTIC_TEST

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.

Also known as: CT angiography (CTA), CTCA

CT Coronary Angiography (CTCA)[Group B]

Traditional Strategy PROCEDURE

Participants randomized to traditional care will be assessed and discharged/treated according to routine standard-of-care procedures in the institution's emergency department.

Also known as: Standard of Care (SOC), Traditional, Standard of Care, Routine Care

Traditional Strategy [Group A]

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• American College of Radiology: lead
• Pennsylvania Department of Health: collaborator

Study Sites (5)

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

Penn State Hershey - Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Penn-Presbyterian Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pennsylvania Health System

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (2)

• Bittner DO, Mayrhofer T, Bamberg F, Hallett TR, Janjua S, Addison D, Nagurney JT, Udelson JE, Lu MT, Truong QA, Woodard PK, Hollander JE, Miller C, Chang AM, Singh H, Litt H, Hoffmann U, Ferencik M. Impact of Coronary Calcification on Clinical Management in Patients With Acute Chest Pain. Circ Cardiovasc Imaging. 2017 May;10(5):e005893. doi: 10.1161/CIRCIMAGING.116.005893.

  PMID: 28487318 DERIVED

• 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.

  PMID: 22449295 DERIVED

MeSH Terms

Conditions

Chest Pain; Acute Coronary Syndrome; Coronary Artery Disease; Myocardial Infarction; Emergencies

Interventions

Computed Tomography Angiography; Standard of Care

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases; Infarction; Ischemia; Pathologic Processes; Necrosis; Disease Attributes

Intervention Hierarchy (Ancestors)

Tomography, X-Ray Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Communications Director
• Organization: American College of Radiology

nfredericks@acr.org

215-574-3150

Study Officials

• Harold I Litt, PhD

  University of Pennsylvania Health System

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2009
• First Posted: July 7, 2009
• Study Start: July 1, 2009
• Primary Completion: February 1, 2012
• Study Completion: April 1, 2012
• Last Updated: March 6, 2024
• Results First Posted: March 6, 2024

Record last verified: 2024-02

Locations

US (5)