Trial Outcomes & Findings for Computed Tomography Coronary Angiogram (CTCA) Versus Traditional Care in Emergency Department Assessment of Potential Acute Coronary Syndromes (ACS) (NCT NCT00933400)

Last Updated: 2024-03-06

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

1392 participants

Primary outcome timeframe

up to 30 days of discharge from the ED

Results posted on

2024-03-06

Participant Flow

The study recruited patients presenting to the emergency department (ED) with potential acute coronary syndromes. After the initial electrocardiogram, consenting subjects were randomization to CCTA or traditional care (2:1ratio). Subjects subsequently found to have a creatinine clearance less than 60 ml/minute or who received a pulmonary embolism protocol CT rather than a CCTA were removed from the study.

Participant milestones

Participant milestones
Measure	CT Coronary Angiography (Group B:CCTA) In the study Coronary computed tomographic angiography (CCTA) -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.	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.
Overall Study STARTED	929	463
Overall Study Index Visit	908	462
Overall Study CCTA Performed	767	0
Overall Study Vital Status Available 30 Days Post ED Triage	908	462
Overall Study 30 Day Post ED Triage Follow-up Data	898	457
Overall Study 1-year Post ED Triage Follow-up Data	907	461
Overall Study COMPLETED	908	462
Overall Study NOT COMPLETED	21	1

Reasons for withdrawal

Reasons for withdrawal
Measure	CT Coronary Angiography (Group B:CCTA) In the study Coronary computed tomographic angiography (CCTA) -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.	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.
Overall Study Withdrawal by Subject	21	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CT Coronary Angiography-based Rapid "Rule Out" Arm (Group B) n=908 Participants Participants receive initial cardiac troponin/creatinine tests. Upon return of normal laboratory values (including a calculated creatinine clearance), participants 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. CT Coronary Angiography(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 Emergency Department (ED) and treating staff immediately upon interpretation; ED staff will determine appropriate course of management. Negative results will result in patient discharge.	Traditional Strategy (Group A) n=462 Participants 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. Traditional Strategy: Participants randomized to traditional care will be assessed and discharged/treated according to routine standard-of-care (SOC) procedures in the institution's emergency department (ED).	Total n=1370 Participants Total of all reporting groups
Age, Continuous	49 years STANDARD_DEVIATION 8.9 • n=5 Participants	50 years STANDARD_DEVIATION 9.5 • n=7 Participants	49 years STANDARD_DEVIATION 9.11 • n=5 Participants
Sex: Female, Male Female	443 Participants n=5 Participants	202 Participants n=7 Participants	645 Participants n=5 Participants
Sex: Female, Male Male	465 Participants n=5 Participants	260 Participants n=7 Participants	725 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	21 Participants n=5 Participants	11 Participants n=7 Participants	32 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	867 Participants n=5 Participants	439 Participants n=7 Participants	1306 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	20 Participants n=5 Participants	12 Participants n=7 Participants	32 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Asian	11 Participants n=5 Participants	7 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	520 Participants n=5 Participants	286 Participants n=7 Participants	806 Participants n=5 Participants
Race (NIH/OMB) White	359 Participants n=5 Participants	158 Participants n=7 Participants	517 Participants n=5 Participants
Race (NIH/OMB) More than one race	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	9 Participants n=5 Participants	4 Participants n=7 Participants	13 Participants n=5 Participants
Cardiac history and risk factors Hypertension	463 Participants n=5 Participants	232 Participants n=7 Participants	695 Participants n=5 Participants
Cardiac history and risk factors Hypercholesterolemia	249 Participants n=5 Participants	118 Participants n=7 Participants	367 Participants n=5 Participants
Cardiac history and risk factors Family History of CAD	268 Participants n=5 Participants	126 Participants n=7 Participants	394 Participants n=5 Participants
Cardiac history and risk factors Diabetes Mellitus	130 Participants n=5 Participants	64 Participants n=7 Participants	194 Participants n=5 Participants
Cardiac history and risk factors Current Tobacco use	291 Participants n=5 Participants	156 Participants n=7 Participants	447 Participants n=5 Participants
Cardiac history and risk factors Cocaine use in last week	49 Participants n=5 Participants	20 Participants n=7 Participants	69 Participants n=5 Participants
Cardiac history and risk factors Myocardial infarction	10 Participants n=5 Participants	6 Participants n=7 Participants	16 Participants n=5 Participants
Cardiac history and risk factors Heart failure	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants
Presenting electrocardiogram Normal	584 Participants n=5 Participants	299 Participants n=7 Participants	883 Participants n=5 Participants
Presenting electrocardiogram Nonspecific	208 Participants n=5 Participants	111 Participants n=7 Participants	319 Participants n=5 Participants
Presenting electrocardiogram Early repolarization	24 Participants n=5 Participants	14 Participants n=7 Participants	38 Participants n=5 Participants
Presenting electrocardiogram Non-diagnostic	68 Participants n=5 Participants	24 Participants n=7 Participants	92 Participants n=5 Participants
Presenting electrocardiogram Ischemia (inadequate blood supply) known to be old	11 Participants n=5 Participants	6 Participants n=7 Participants	17 Participants n=5 Participants
Presenting electrocardiogram Ischemia (inadequate blood supply) not known to be old	10 Participants n=5 Participants	7 Participants n=7 Participants	17 Participants n=5 Participants
Presenting electrocardiogram ST Elevation consistent with Acute Myocardial Infarction (AMI)-old	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Presenting electrocardiogram Other/Unknown	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: up to 30 days of discharge from the ED

Outcome measures

Outcome measures
Measure	CT Coronary Angiography (Group B) n=908 Participants Participants randomized to CT coronary angiography with scan planned as soon as the CT scanner is available following the initial values assessment (expected within 90 minutes). Participants with negative test results will be discharged unless other indications for admission per standard of care. Participants with positive test results will be admitted to the hospital for further management as dictated by the admitting team. CT Coronary Angiography: CT coronary angiography was 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 was 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 were communicated to the responsible Emergency Department (ED) and treating staff immediately upon interpretation; ED staff will determine appropriate course of management.	Traditional Strategy (Group A) n=462 Participants 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. Traditional Strategy: Participants randomized to traditional care will be assessed and discharged/treated according to routine standard-of-care procedures in the institution's emergency department.	Negative CT Coronary Angiography-based Rapid "Rule Out" (Group B) n=640 Participants This group contains only those subjects from Group B where the imaging test was completed and negative: the participant had a \<= 50% stenosis of the right coronary, left main, left anterior descending, and circumflex arteries and of their branches in contrast-enhanced CT coronary angiography.
Rates of Major Cardiac Events (AMI or Cardiac Death) Within 30 Days Death	0 Participants	0 Participants	0 Participants
Rates of Major Cardiac Events (AMI or Cardiac Death) Within 30 Days AMI	10 Participants	5 Participants	0 Participants

SECONDARY outcome

Timeframe: baseline

The algorithm used for diagnosis of Significant coronary artery disease is provided in the Appendix of the protocol.

Outcome measures

Outcome measures
Measure	CT Coronary Angiography (Group B) n=908 Participants Participants randomized to CT coronary angiography with scan planned as soon as the CT scanner is available following the initial values assessment (expected within 90 minutes). Participants with negative test results will be discharged unless other indications for admission per standard of care. Participants with positive test results will be admitted to the hospital for further management as dictated by the admitting team. CT Coronary Angiography: CT coronary angiography was 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 was 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 were communicated to the responsible Emergency Department (ED) and treating staff immediately upon interpretation; ED staff will determine appropriate course of management.	Traditional Strategy (Group A) n=462 Participants 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. Traditional Strategy: Participants randomized to traditional care will be assessed and discharged/treated according to routine standard-of-care procedures in the institution's emergency department.	Negative CT Coronary Angiography-based Rapid "Rule Out" (Group B) This group contains only those subjects from Group B where the imaging test was completed and negative: the participant had a \<= 50% stenosis of the right coronary, left main, left anterior descending, and circumflex arteries and of their branches in contrast-enhanced CT coronary angiography.
Significant Coronary Artery Disease Detected Within Index Hospitalization as Assessed by Medical Record Review. Discharge from ED	450 Participants	105 Participants	—
Significant Coronary Artery Disease Detected Within Index Hospitalization as Assessed by Medical Record Review. Admission/observation to ED	458 Participants	357 Participants	—
Significant Coronary Artery Disease Detected Within Index Hospitalization as Assessed by Medical Record Review. Significant coronary disease	82 Participants	16 Participants	—

SECONDARY outcome

Timeframe: 1-7 days

Population: Results report for all patient and for those with a negative index visit assessment.

Compare the length of hospital stay in hours between the groups

Outcome measures

Outcome measures
Measure	CT Coronary Angiography (Group B) n=908 Participants Participants randomized to CT coronary angiography with scan planned as soon as the CT scanner is available following the initial values assessment (expected within 90 minutes). Participants with negative test results will be discharged unless other indications for admission per standard of care. Participants with positive test results will be admitted to the hospital for further management as dictated by the admitting team. CT Coronary Angiography: CT coronary angiography was 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 was 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 were communicated to the responsible Emergency Department (ED) and treating staff immediately upon interpretation; ED staff will determine appropriate course of management.	Traditional Strategy (Group A) n=462 Participants 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. Traditional Strategy: Participants randomized to traditional care will be assessed and discharged/treated according to routine standard-of-care procedures in the institution's emergency department.	Negative CT Coronary Angiography-based Rapid "Rule Out" (Group B) This group contains only those subjects from Group B where the imaging test was completed and negative: the participant had a \<= 50% stenosis of the right coronary, left main, left anterior descending, and circumflex arteries and of their branches in contrast-enhanced CT coronary angiography.
Mean Length of Hospital Stay After Initial Visit Overall	18.0 hours Interval 7.6 to 27.2	24.8 hours Interval 19.2 to 30.5	—
Mean Length of Hospital Stay After Initial Visit Subjects with negative test	12.3 hours Interval 7.0 to 24.3	24.7 hours Interval 19.7 to 29.6	—

SECONDARY outcome

Timeframe: 1-7 Days

Downstream diagnostic test during the index visit including Hospital admission or observation.

Outcome measures

Outcome measures
Measure	CT Coronary Angiography (Group B) n=908 Participants Participants randomized to CT coronary angiography with scan planned as soon as the CT scanner is available following the initial values assessment (expected within 90 minutes). Participants with negative test results will be discharged unless other indications for admission per standard of care. Participants with positive test results will be admitted to the hospital for further management as dictated by the admitting team. CT Coronary Angiography: CT coronary angiography was 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 was 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 were communicated to the responsible Emergency Department (ED) and treating staff immediately upon interpretation; ED staff will determine appropriate course of management.	Traditional Strategy (Group A) n=462 Participants 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. Traditional Strategy: Participants randomized to traditional care will be assessed and discharged/treated according to routine standard-of-care procedures in the institution's emergency department.	Negative CT Coronary Angiography-based Rapid "Rule Out" (Group B) This group contains only those subjects from Group B where the imaging test was completed and negative: the participant had a \<= 50% stenosis of the right coronary, left main, left anterior descending, and circumflex arteries and of their branches in contrast-enhanced CT coronary angiography.
Health Care Utilization During the Index Hospitalization. CCTA	767 Participants	26 Participants	—
Health Care Utilization During the Index Hospitalization. Stress testing, with or without imaging	124 Participants	267 Participants	—
Health Care Utilization During the Index Hospitalization. Cardiac catheterization	37 Participants	18 Participants	—
Health Care Utilization During the Index Hospitalization. No additional Diagnostic tests	80 Participants	167 Participants	—
Health Care Utilization During the Index Hospitalization. Hosp. Admission or observation	458 Participants	357 Participants	—

SECONDARY outcome

Timeframe: Through 1-yr study follow up

Population: Subjects with index visit and know outcome at 1-yr post ED triage

Outcome measures

Outcome measures
Measure	CT Coronary Angiography (Group B) n=852 Participants Participants randomized to CT coronary angiography with scan planned as soon as the CT scanner is available following the initial values assessment (expected within 90 minutes). Participants with negative test results will be discharged unless other indications for admission per standard of care. Participants with positive test results will be admitted to the hospital for further management as dictated by the admitting team. CT Coronary Angiography: CT coronary angiography was 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 was 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 were communicated to the responsible Emergency Department (ED) and treating staff immediately upon interpretation; ED staff will determine appropriate course of management.	Traditional Strategy (Group A) n=438 Participants 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. Traditional Strategy: Participants randomized to traditional care will be assessed and discharged/treated according to routine standard-of-care procedures in the institution's emergency department.	Negative CT Coronary Angiography-based Rapid "Rule Out" (Group B) This group contains only those subjects from Group B where the imaging test was completed and negative: the participant had a \<= 50% stenosis of the right coronary, left main, left anterior descending, and circumflex arteries and of their branches in contrast-enhanced CT coronary angiography.
Cardiac Health Care Utilization 1 Year Post Triage/Presentation. Emergency department visit	305 Participants	166 Participants	—
Cardiac Health Care Utilization 1 Year Post Triage/Presentation. Hospital admission	137 Participants	74 Participants	—
Cardiac Health Care Utilization 1 Year Post Triage/Presentation. Cardiologist office visit	148 Participants	53 Participants	—
Cardiac Health Care Utilization 1 Year Post Triage/Presentation. CCTA	2 Participants	5 Participants	—
Cardiac Health Care Utilization 1 Year Post Triage/Presentation. Stress testing without imaging	19 Participants	2 Participants	—
Cardiac Health Care Utilization 1 Year Post Triage/Presentation. Stress testing with imaging	60 Participants	33 Participants	—
Cardiac Health Care Utilization 1 Year Post Triage/Presentation. Catheterization	24 Participants	13 Participants	—
Cardiac Health Care Utilization 1 Year Post Triage/Presentation. Echocardiogram	49 Participants	26 Participants	—

SECONDARY outcome

Timeframe: Through 1-yr study follow up

Population: Subject with index visit, Vital status available at 1-yr post ED triage, and known outcome

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

Outcome measures

Outcome measures
Measure	CT Coronary Angiography (Group B) n=907 Participants Participants randomized to CT coronary angiography with scan planned as soon as the CT scanner is available following the initial values assessment (expected within 90 minutes). Participants with negative test results will be discharged unless other indications for admission per standard of care. Participants with positive test results will be admitted to the hospital for further management as dictated by the admitting team. CT Coronary Angiography: CT coronary angiography was 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 was 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 were communicated to the responsible Emergency Department (ED) and treating staff immediately upon interpretation; ED staff will determine appropriate course of management.	Traditional Strategy (Group A) n=461 Participants 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. Traditional Strategy: Participants randomized to traditional care will be assessed and discharged/treated according to routine standard-of-care procedures in the institution's emergency department.	Negative CT Coronary Angiography-based Rapid "Rule Out" (Group B) This group contains only those subjects from Group B where the imaging test was completed and negative: the participant had a \<= 50% stenosis of the right coronary, left main, left anterior descending, and circumflex arteries and of their branches in contrast-enhanced CT coronary angiography.
Major Adverse Cardiac Event (MACE, Including Myocardial Infarction & Cardiac Death) and Revascularization for Participants Within 1 Year Post Triage/Presentation All-Cause Mortality	2 Participants	3 Participants	—
Major Adverse Cardiac Event (MACE, Including Myocardial Infarction & Cardiac Death) and Revascularization for Participants Within 1 Year Post Triage/Presentation Cardiac Death	1 Participants	0 Participants	—
Major Adverse Cardiac Event (MACE, Including Myocardial Infarction & Cardiac Death) and Revascularization for Participants Within 1 Year Post Triage/Presentation AMI	11 Participants	5 Participants	—
Major Adverse Cardiac Event (MACE, Including Myocardial Infarction & Cardiac Death) and Revascularization for Participants Within 1 Year Post Triage/Presentation MACE	12 Participants	5 Participants	—
Major Adverse Cardiac Event (MACE, Including Myocardial Infarction & Cardiac Death) and Revascularization for Participants Within 1 Year Post Triage/Presentation Revascularization	25 Participants	7 Participants	—

Adverse Events

CT Coronary Angiography-based Rapid "Rule Out" (Group B)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 2 deaths

Traditional Strategy (Group A)

Serious events: 2 serious events

Other events: 0 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	CT Coronary Angiography-based Rapid "Rule Out" (Group B) n=929 participants at risk 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. 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.	Traditional Strategy (Group A) n=463 participants at risk 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. Traditional Strategy: Participants randomized to traditional care will be assessed and discharged/treated according to routine standard-of-care procedures in the institution's emergency department.
General disorders General disorders and administration site conditions (death)	0.00% 0/929 • within 30 days of study scan and at 1 year follow up (or study termination visit if occurring prior to 1 year follow up) Adverse events were assessed via record review, patient and secondary contacts, and the Social Security Death Master File was consulted for vital status (date last accessed for all patients, January 25, 2012).	0.22% 1/463 • Number of events 1 • within 30 days of study scan and at 1 year follow up (or study termination visit if occurring prior to 1 year follow up) Adverse events were assessed via record review, patient and secondary contacts, and the Social Security Death Master File was consulted for vital status (date last accessed for all patients, January 25, 2012).
Cardiac disorders 10040741 - Sinus Bradycardia	0.00% 0/929 • within 30 days of study scan and at 1 year follow up (or study termination visit if occurring prior to 1 year follow up) Adverse events were assessed via record review, patient and secondary contacts, and the Social Security Death Master File was consulted for vital status (date last accessed for all patients, January 25, 2012).	0.22% 1/463 • Number of events 1 • within 30 days of study scan and at 1 year follow up (or study termination visit if occurring prior to 1 year follow up) Adverse events were assessed via record review, patient and secondary contacts, and the Social Security Death Master File was consulted for vital status (date last accessed for all patients, January 25, 2012).

Other adverse events

Adverse event data not reported

Additional Information

Communications Director

American College of Radiology

Phone: 215-574-3150

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place