Chest PainNCT00933400
Computed Tomography Coronary Angiogram (CTCA) Versus Traditional Care in Emergency Department Assessment of Potential Acute Coronary Syndromes (ACS)
A study testing CT Coronary Angiography (CTCA) and Traditional Strategy in people with Chest Pain and Acute Coronary Syndrome, run by American College of Radiology at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Chest Pain, Acute Coronary Syndrome, Acute Myocardial Infarction
- What is being tested?
- CT Coronary Angiography (CTCA) and Traditional Strategy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,392 participants
- Where
- 5 sitesUnited States
- Study dates
- Jul 2009to Apr 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Penn State Hershey - Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
Penn-Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19104
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27157
About this study
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)
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.
Read the 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.
- Being tested
- CT Coronary Angiography (CTCA), Traditional Strategy
- 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
- Medical subject headings
- Chest Pain, Acute Coronary Syndrome, Coronary Artery Disease, Myocardial Infarction, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT Coronary Angiography (CTCA)Diagnostic test
Also called CT angiography (CTA), CTCA
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.
Traditional StrategyProcedure or surgery
Also called Standard of Care (SOC), Traditional, Standard of Care, Routine 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: CT Coronary Angiography (CTCA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
The algorithm used for diagnosis of Significant coronary artery disease is provided in the Appendix of the protocol.
Measured: baseline
Mean Length of Hospital Stay After Initial Visit
Compare the length of hospital stay in hours between the groups
Measured: 1-7 days
Health Care Utilization During the Index Hospitalization.
Downstream diagnostic test during the index visit including Hospital admission or observation.
Measured: 1-7 Days
Cardiac Health Care Utilization 1 Year Post Triage/Presentation.
Measured: 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
MACE at 1 year was determined by Patient telephone contact Medical record review Records at the presenting and neighboring hospitals were reviewed for repeat visits When these methods failed to provide survival information, we searched the Social Security Death Master File
Measured: Through 1-yr study follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionFeb 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chest PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,392 participants (actual)
Sponsor and investigators
- Lead sponsor
- American College of Radiology
- Sponsor type
- University, hospital or other
- Collaborators
- Pennsylvania Department of Health
- Responsible party
- Sponsor
- Investigators
- Harold I Litt, PhD, Study chair, University of Pennsylvania Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00933400
- Sponsor's protocol ID
- ACRIN PA 4005
- Status last verified
- Feb 2024
- First submitted
- 2 Jul 2009
- Last updated
- 6 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 28487318Litt 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.
PubMed 22449295
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00933400
- Acronym / sponsor ID
- ACRIN PA 4005
- Keywords
- Computed Tomography, CT Angiography (CTA), Cardiac CT, CT, Cardiac CTA (CCTA), Chest Pain, Heart Attack, Emergency Department
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,392 participants (actual)
- Lead sponsor
- American College of RadiologyUniversity, hospital or other
- Collaborators
- Pennsylvania Department of Health
- Study start
- Jul 2009
- Primary completion
- Feb 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 7 Jul 2009 (estimated)
- Results
- Posted 6 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional Strategy [Group A] | Active comparator | Procedure: Traditional StrategyIn 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. |
| CT Coronary Angiography (CTCA)[Group B] | Experimental | Diagnostic Test: CT Coronary Angiography (CTCA)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. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT Coronary Angiography (CTCA)Also: CT angiography (CTA), CTCACT 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. | Diagnostic test | CT Coronary Angiography (CTCA)[Group B] |
| Traditional StrategyAlso: Standard of Care (SOC), Traditional, Standard of Care, Routine CareParticipants randomized to traditional care will be assessed and discharged/treated according to routine standard-of-care procedures in the institution's emergency department. | Procedure or surgery | Traditional Strategy [Group A] |
Primary outcome
Rates of Major Cardiac Events (AMI or Cardiac Death) Within 30 Days
Time frame: up to 30 days of discharge from the ED
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.
5 secondary outcomes
Significant Coronary Artery Disease Detected Within Index Hospitalization as Assessed by Medical Record Review.
Time frame: baseline
Mean Length of Hospital Stay After Initial Visit
Time frame: 1-7 days
Health Care Utilization During the Index Hospitalization.
Time frame: 1-7 Days
Cardiac Health Care Utilization 1 Year Post Triage/Presentation.
Time frame: 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
Time frame: Through 1-yr study follow up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28487318Bittner 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.
- Derived from this study: PubMed 22449295Litt 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harold I Litt, PhD study chair
University of Pennsylvania Health System
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT Coronary Angiography (CTCA) and Traditional Strategy in people with Chest Pain and Acute Coronary Syndrome, run by American College of Radiology at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of Major Cardiac Events (AMI or Cardiac Death) Within 30 Days (time frame: up to 30 days of discharge from the ED). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00933400, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024.