Clinical trial NCT00933400: Computed Tomography Coronary Angiogram (CTCA) Versus Traditional Care in Emergency Department Assessment of Potential Acute Coronary Syndromes (ACS)
Official title: Randomized Controlled Study of a Rapid "Rule Out" Strategy Using Computed Tomography Coronary Angiogram (CTCA) Versus Traditional Care for Low- to Intermediate-Risk Emergency Department (ED) Patients With Potential Acute Coronary Syndromes (ACS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: American College of Radiology
Sponsor class: OTHER
Collaborators: name: Pennsylvania Department of Health
First posted: 2009-07-07
Enrollment: 1392
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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 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

Primary outcomes:
measure: Rates of Major Cardiac Events (AMI or Cardiac Death) Within 30 Days
timeFrame: up to 30 days of discharge from the ED
Secondary outcomes:
measure: Significant Coronary Artery Disease Detected Within Index Hospitalization as Assessed by Medical Record Review.
timeFrame: baseline
measure: Mean Length of Hospital Stay After Initial Visit
timeFrame: 1-7 days
measure: Health Care Utilization During the Index Hospitalization.
timeFrame: 1-7 Days
measure: Cardiac Health Care Utilization 1 Year Post Triage/Presentation.
timeFrame: Through 1-yr study follow up
measure: Major Adverse Cardiac Event (MACE, Including Myocardial Infarction & Cardiac Death) and Revascularization for Participants Within 1 Year Post Triage/Presentation
timeFrame: Through 1-yr study follow up
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Baptist Medical Center
state: North Carolina
city: Hershey
country: United States
facility: Penn State Hershey - Milton S. Hershey Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Penn-Presbyterian Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania Health System
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania Health System
name: Harold I Litt, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.