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

Primary Purpose

Chest Pain, Acute Coronary Syndrome, Acute Myocardial Infarction

Status

Unknown status

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

CT Coronary Angiography

Traditional, Standard of Care

About this trial

This is an interventional diagnostic trial for Chest Pain focused on measuring Computed Tomography, CTA, Cardiac CT, CT, Cardiac CTA, Chest Pain, Heart Attack, Emergency Department, Myocardial Infarction, Cost Effectiveness, Acute Coronary Event, Heart Imaging

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Wake Forest University Baptist Medical Center
Penn State Hershey - Milton S. Hershey Medical Center
Penn-Presbyterian Medical Center
University of Pennsylvania Health System
University of Pittsburgh Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Traditional Strategy (Group A)

CT Coronary Angiography (Group B)

Arm Description

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.

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.

Outcomes

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.

Secondary Outcome Measures

To estimate and compare the rates of significant CAD detected within the index visit in participants across the two study arms.

To compare hospital length of stay across the two study groups.

To compare health care utilization and cost incurred by participants in the two study groups during the index hospitalization.

To compare cardiac health care utilization and cost incurred by participants in the two study groups during 1 year post triage/presentation.

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.

Full Information

NCT ID

NCT00933400

First Posted

July 2, 2009

Last Updated

March 13, 2012

Sponsor

American College of Radiology Imaging Network

Collaborators

Pennsylvania Department of Health

1. Study Identification

Unique Protocol Identification Number

NCT00933400

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2012

Overall Recruitment Status

Unknown status

Study Start Date

July 2009 (undefined)

Primary Completion Date

February 2012 (Actual)

Study Completion Date

April 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

American College of Radiology Imaging Network

Collaborators

Pennsylvania Department of Health

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Computed Tomography, CTA, Cardiac CT, CT, Cardiac CTA, Chest Pain, Heart Attack, Emergency Department, Myocardial Infarction, Cost Effectiveness, Acute Coronary Event, Heart Imaging

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1365 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Traditional Strategy (Group A)

Arm Type

Active Comparator

Arm Description

Arm Title

CT Coronary Angiography (Group B)

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

CT Coronary Angiography

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Traditional, Standard of Care

Intervention Description

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

Primary Outcome Measure Information:

Title

Time Frame

Within 30 days of discharge from the ED

Secondary Outcome Measure Information:

Title

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

Title

To compare hospital length of stay across the two study groups.

Time Frame

1-7 days

Title

To compare health care utilization and cost incurred by participants in the two study groups during the index hospitalization.

Time Frame

1-7 Days

Title

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

Title

Time Frame

Through 1-yr study follow up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Harold I Litt, PhD

Organizational Affiliation

University of Pennsylvania Health System

Official's Role

Study Chair

Facility Information:

Facility Name

Wake Forest University Baptist Medical Center

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27157

Country

United States

Facility Name

Penn State Hershey - Milton S. Hershey Medical Center

City

Hershey

State/Province

Pennsylvania

ZIP/Postal Code

17033

Country

United States

Facility Name

Penn-Presbyterian Medical Center

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

University of Pennsylvania Health System

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

University of Pittsburgh Medical Center

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

28487318

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.

Results Reference

derived

PubMed Identifier

22449295

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.

Results Reference

derived

Links:

URL

http://www.acrin.org/4005_protocol.aspx

Description

Click here for more information about this study: ACRIN PA 4005, CT Coronary Angiography Versus Traditional Care for Low-Risk ED Patients With ACS.

Learn more about this trial

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

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