| Primary | 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. | | Posted | | Count of Participants | | Participants | | up to 30 days of discharge from the ED | | | | ID | Title | Description |
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| OG000 | CT Coronary Angiography (Group B) | 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. | | OG001 | 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. 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. | | OG002 | 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. |
| | | Title | Denominators | Categories |
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| Death | | | | AMI | | |
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| Difference in AMI rate. NULL: equal rates of AMI in both Groups. | | | | | Percent Difference | 0.02 | | | 2-Sided | 95 | -5.6 | 5.7 | | | | | Equivalence | | |
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| Secondary | 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. | | Posted | | Count of Participants | | Participants | | baseline | | | | ID | Title | Description |
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| OG000 | CT Coronary Angiography-based Rapid "Rule Out" (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. 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. |
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| Secondary | Mean Length of Hospital Stay After Initial Visit | Compare the length of hospital stay in hours between the groups | Results report for all patient and for those with a negative index visit assessment. | Posted | | Mean | Inter-Quartile Range | hours | | 1-7 days | | | | ID | Title | Description |
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| OG000 | CT Coronary Angiography-based Rapid "Rule Out" (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. 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. |
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| Secondary | Health Care Utilization During the Index Hospitalization. | Downstream diagnostic test during the index visit including Hospital admission or observation. | | Posted | | Count of Participants | | Participants | | 1-7 Days | | | | ID | Title | Description |
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| OG000 | CT Coronary Angiography-based Rapid "Rule Out" (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. 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. |
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| Secondary | Cardiac Health Care Utilization 1 Year Post Triage/Presentation. | | Subjects with index visit and know outcome at 1-yr post ED triage | Posted | | Count of Participants | | Participants | | Through 1-yr study follow up | | | | ID | Title | Description |
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| OG000 | 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. 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. |
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| Secondary | 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 | Subject with index visit, Vital status available at 1-yr post ED triage, and known outcome | Posted | | Count of Participants | | Participants | | Through 1-yr study follow up | | | | ID | Title | Description |
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| OG000 | CT Coronary Angiography-based Rapid "Rule Out" (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. 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. |
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