Acute Coronary SyndromeNCT01035047
Randomized Investigation of Chest Pain Diagnostic Strategies
A study testing Clinical decision unit care, coupled with cardiac MRI in people with Acute Coronary Syndrome and Chest Pain, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
Clinical decision units (CDUs) improve resource utilization and are a recommended care option by the American College of Cardiology / American Heart Association, but are underutilized in non-low risk chest pain patients due to weaknesses of traditional cardiac testing. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Acute Coronary Syndrome, Chest Pain
- What is being tested?
- Clinical decision unit care, coupled with cardiac MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Aug 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than or equal to 21 years of age at the time of enrollment
- Chest discomfort or other symptoms consistent with possible ACS as indicated by the treating physician after obtaining an ECG and cardiac biomarkers for the patient's evaluation
- Thrombolysis in myocardial infarction (TIMI) risk score >/= 2 or physician impression of intermediate or high likelihood symptoms represent ACS
- Patient requires an inpatient or CDU evaluation for their chest pain
- The treating physician feels the patient could be discharged home if cardiac disease was excluded
- The treating physician feels the patient is safe for CDU care
- Pretest probability assessment The assessment of intermediate risk for developing ACS will be based on a TIMI risk score >/= 2 and / or a board certified / board eligible emergency physician clinical impression of intermediate or high likelihood that the symptoms represent ACS. Physicians are encouraged to use the 2007 American College of Cardiology (ACC)/American Heart Association (AHA) guidelines as a framework for this assessment.
Who cannot join
- Elevated cardiac biomarkers
- New ST-segment elevation on any electrocardiogram (>/= 1 mV)
- New ST-segment depression on any electrocardiogram (>/= 2 mV)
- Known inducible cardiac ischemia without subsequent revascularization
- Unable to lie flat
- Symptomatic hypotension at the time of enrollment (systolic < 90 mm Hg)
Show all 15Show fewer
- Contra-indications to MRI (examples: Pacemaker, defibrillator, cerebral aneurysm clips, metallic ocular foreign body, implanted devices, severe claustrophobia)
- Patient refusal or inability to comply with medical record review and follow up
- Terminal diagnosis with life expectancy less than 3 months
- Currently Pregnant
- Creatinine clearance < 45 ml/min at the time of enrollment or clinical concern for acute kidney injury
- Chronic liver disease with a creatinine clearance of <60 ml/min at the time of enrollment
- Hepato-renal syndrome
- History of liver, heart, or kidney transplant
- Confirmed angioplasty, stent placement, or coronary artery bypass grafting (CABG) within the last 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27157
About this study
Clinical decision units (CDUs) improve resource utilization and are a recommended care option by the American College of Cardiology / American Heart Association, but are underutilized in non-low risk chest pain patients due to weaknesses of traditional cardiac testing. Cardiac magnetic resonance imaging (CMR) is sensitive and specific for ischemia, can simultaneously assess cardiac function and myocardial perfusion, and could revolutionize the diagnostic process for intermediate risk patients with chest pain. The primary objective of this trial is to measure the efficiency and safety of a combined CDU-CMR care pathway compared to inpatient care among patients with non-low risk acute chest pain.
Read the detailed description
Despite spending $12 billion annually on the emergency evaluation of chest pain in the US, only 15% of admitted patients have a cardiac cause of their presenting symptoms. Clinical decision units (CDUs) improve resource utilization and are a recommended care option by the American College of Cardiology / American Heart Association, but are underutilized in non-low risk chest pain patients due to weaknesses of traditional cardiac testing. Cardiac magnetic resonance imaging (CMR) is sensitive and specific for ischemia, can simultaneously assess cardiac function and myocardial perfusion, and could revolutionize the diagnostic process for intermediate risk patients with chest pain. The superior accuracy of CMR could decrease testing and invasive procedures. The high sensitivity for ongoing ischemia could allow imaging in parallel with cardiac markers. As a result, CMR could improve the care of emergency department (ED) patients with intermediate risk chest pain. However, the efficiency and safety of CMR has not been extensively tested in the CDU setting.
Primary Hypothesis: A CDU-CMR strategy will reduce the occurrence of the composite of revascularization, re-hospitalization, and recurrent cardiac testing at 90 days when compared to an inpatient care strategy.
Methods: Participants (n=146) at intermediate risk for acute coronary syndrome (ACS) will be recruited into a clinical trial from Wake Forest University Baptist Medical Center (WFUBMC) ED. Participants will be equally randomized to CDU-CMR or inpatient care. CDU-CMR participants will undergo resting and stress CMR imaging in parallel with serial cardiac markers. Inpatient care participants will undergo serial cardiac markers followed by existing cardiac testing as determined by their care providers. The primary outcome is the composite of 90 day revascularization, re-hospitalization, and recurrent cardiac testing. The secondary outcome is index hospitalization length of stay. Safety events include ACS after discharge, mortality, and stress testing-related adverse events.
- Conditions
- Acute Coronary Syndrome, Chest Pain
- Being tested
- Clinical decision unit care, coupled with cardiac MRI
- Keywords
- Acute Coronary Syndrome, Chest pain, Cardiac MRI, Risk Stratification, Emergency Department
- Medical subject headings
- Acute Coronary Syndrome, Chest Pain, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical decision unit care, coupled with cardiac MRIOther
After ED evaluation, patients are randomized to clinical decision unit care or inpatient care. Patients in the clinical decision unit will also undergo a stress cardiac MRI. Patients in the inpatient care arm may undergo any desired testing, including cardiac MRI, as determined by their treating physician.
| Study group | Role | What they receive |
|---|---|---|
| Inpatient Care | No intervention | This is the comparison arm. Patients are admitted to the hospital and undergo usual care. |
| CDU-CMR Protocol | Experimental | Patients will be transferred to the clinical decision unit and undergo a stress cardiac MRI evaluation. Receives: Other: Clinical decision unit care, coupled with cardiac MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Composite of Revascularization, Re-hospitalization, and Recurrent Cardiac Testing Through 90 Days.
Measured: Index Hospitalization through 90 days
Secondary outcomes (4)
Length of Stay
Measured: Duration of Index Hospitalization, an average of 1-2 days
Acute Coronary Syndrome
Measured: Index Hospitalization discharge through 90 days
Mortality
Measured: Index Hospitalization through 90 days
Stress Testing-related Adverse Event
Measured: Index Hospitalization through 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2009 (estimated)
- Study startJan 2010
- Primary completionOct 2011
- Study completionAug 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 (56)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Chadwick Miller, M.D., Principal investigator, WFUBMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01035047
- Sponsor's protocol ID
- IRB00010410
- Other IDs
- 1R21HL097131-01A1
- Status last verified
- Aug 2018
- First submitted
- 17 Dec 2009
- Last updated
- 10 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Rosamond W, Flegal K, Friday G, Furie K, Go A, Greenlund K, Haase N, Ho M, Howard V, Kissela B, Kittner S, Lloyd-Jones D, McDermott M, Meigs J, Moy C, Nichol G, O'Donnell CJ, Roger V, Rumsfeld J, Sorlie P, Steinberger J, Thom T, Wasserthiel-Smoller S, Hong Y; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2007 update: a report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation. 2007 Feb 6;115(5):e69-171. doi: 10.1161/CIRCULATIONAHA.106.179918. Epub 2006 Dec 28. No abstract available.
PubMed 17194875McCaig LF, Nawar EW. National Hospital Ambulatory Medical Care Survey: 2004 emergency department summary. Adv Data. 2006 Jun 23;(372):1-29.
PubMed 16841785Christenson J, Innes G, McKnight D, Thompson CR, Wong H, Yu E, Boychuk B, Grafstein E, Rosenberg F, Gin K, Anis A, Singer J. A clinical prediction rule for early discharge of patients with chest pain. Ann Emerg Med. 2006 Jan;47(1):1-10. doi: 10.1016/j.annemergmed.2005.08.007. Epub 2005 Oct 19.
PubMed 16387209Goldstein JA, Gallagher MJ, O'Neill WW, Ross MA, O'Neil BJ, Raff GL. A randomized controlled trial of multi-slice coronary computed tomography for evaluation of acute chest pain. J Am Coll Cardiol. 2007 Feb 27;49(8):863-71. doi: 10.1016/j.jacc.2006.08.064. Epub 2007 Feb 12.
PubMed 17320744Farkouh ME, Smars PA, Reeder GS, Zinsmeister AR, Evans RW, Meloy TD, Kopecky SL, Allen M, Allison TG, Gibbons RJ, Gabriel SE. A clinical trial of a chest-pain observation unit for patients with unstable angina. Chest Pain Evaluation in the Emergency Room (CHEER) Investigators. N Engl J Med. 1998 Dec 24;339(26):1882-8. doi: 10.1056/NEJM199812243392603.
PubMed 9862943Heller GV, Stowers SA, Hendel RC, Herman SD, Daher E, Ahlberg AW, Baron JM, Mendes de Leon CF, Rizzo JA, Wackers FJ. Clinical value of acute rest technetium-99m tetrofosmin tomographic myocardial perfusion imaging in patients with acute chest pain and nondiagnostic electrocardiograms. J Am Coll Cardiol. 1998 Apr;31(5):1011-7. doi: 10.1016/s0735-1097(98)00057-6.
PubMed 9562001Sprivulis PC, Da Silva JA, Jacobs IG, Frazer AR, Jelinek GA. The association between hospital overcrowding and mortality among patients admitted via Western Australian emergency departments. Med J Aust. 2006 Mar 6;184(5):208-12. doi: 10.5694/j.1326-5377.2006.tb00416.x.
PubMed 16515429Miro O, Antonio MT, Jimenez S, De Dios A, Sanchez M, Borras A, Milla J. Decreased health care quality associated with emergency department overcrowding. Eur J Emerg Med. 1999 Jun;6(2):105-7. doi: 10.1097/00063110-199906000-00003.
PubMed 10461551Pope JH, Aufderheide TP, Ruthazer R, Woolard RH, Feldman JA, Beshansky JR, Griffith JL, Selker HP. Missed diagnoses of acute cardiac ischemia in the emergency department. N Engl J Med. 2000 Apr 20;342(16):1163-70. doi: 10.1056/NEJM200004203421603.
PubMed 10770981Braunwald E, Antman EM, Beasley JW, Califf RM, Cheitlin MD, Hochman JS, Jones RH, Kereiakes D, Kupersmith J, Levin TN, Pepine CJ, Schaeffer JW, Smith EE 3rd, Steward DE, Theroux P, Gibbons RJ, Alpert JS, Faxon DP, Fuster V, Gregoratos G, Hiratzka LF, Jacobs AK, Smith SC Jr; American College of Cardiology; American Heart Association. Committee on the Management of Patients With Unstable Angina. ACC/AHA 2002 guideline update for the management of patients with unstable angina and non-ST-segment elevation myocardial infarction--summary article: a report of the American College of Cardiology/American Heart Association task force on practice guidelines (Committee on the Management of Patients With Unstable Angina). J Am Coll Cardiol. 2002 Oct 2;40(7):1366-74. doi: 10.1016/s0735-1097(02)02336-7. No abstract available.
PubMed 12383588Hoffmann U, Nagurney JT, Moselewski F, Pena A, Ferencik M, Chae CU, Cury RC, Butler J, Abbara S, Brown DF, Manini A, Nichols JH, Achenbach S, Brady TJ. Coronary multidetector computed tomography in the assessment of patients with acute chest pain. Circulation. 2006 Nov 21;114(21):2251-60. doi: 10.1161/CIRCULATIONAHA.106.634808. Epub 2006 Oct 30.
PubMed 17075011Hollander JE, Litt HI, Chase M, Brown AM, Kim W, Baxt WG. Computed tomography coronary angiography for rapid disposition of low-risk emergency department patients with chest pain syndromes. Acad Emerg Med. 2007 Feb;14(2):112-6. doi: 10.1197/j.aem.2006.09.051.
PubMed 17267528Katz DA, Griffith JL, Beshansky JR, Selker HP. The use of empiric clinical data in the evaluation of practice guidelines for unstable angina. JAMA. 1996 Nov 20;276(19):1568-74.
PubMed 8918854Calvin JE, Klein LW, VandenBerg EJ, Meyer P, Parrillo JE. Validated risk stratification model accurately predicts low risk in patients with unstable angina. J Am Coll Cardiol. 2000 Nov 15;36(6):1803-8. doi: 10.1016/s0735-1097(00)00977-3.
PubMed 11092647Tatum JL, Jesse RL, Kontos MC, Nicholson CS, Schmidt KL, Roberts CS, Ornato JP. Comprehensive strategy for the evaluation and triage of the chest pain patient. Ann Emerg Med. 1997 Jan;29(1):116-25. doi: 10.1016/s0196-0644(97)70317-2.
PubMed 8998090
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Investigation of Chest Pain Diagnostic Strategies
- ClinicalTrials.gov ID
- NCT01035047
- Acronym / sponsor ID
- IRB00010410
- Conditions
- Acute Coronary Syndrome, Chest Pain
- Keywords
- Acute Coronary Syndrome, Chest pain, Cardiac MRI, Risk Stratification, Emergency Department
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jan 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 18 Dec 2009 (estimated)
- Results
- Posted 29 Nov 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Clinical decision units (CDUs) improve resource utilization and are a recommended care option by the American College of Cardiology / American Heart Association, but are underutilized in non-low risk chest pain patients due to weaknesses of traditional cardiac testing. Cardiac magnetic resonance imaging (CMR) is sensitive and specific for ischemia, can simultaneously assess cardiac function and myocardial perfusion, and could revolutionize the diagnostic process for intermediate risk patients with chest pain. The primary objective of this trial is to measure the efficiency and safety of a combined CDU-CMR care pathway compared to inpatient care among patients with non-low risk acute chest pain.
Detailed description
Despite spending $12 billion annually on the emergency evaluation of chest pain in the US, only 15% of admitted patients have a cardiac cause of their presenting symptoms. Clinical decision units (CDUs) improve resource utilization and are a recommended care option by the American College of Cardiology / American Heart Association, but are underutilized in non-low risk chest pain patients due to weaknesses of traditional cardiac testing. Cardiac magnetic resonance imaging (CMR) is sensitive and specific for ischemia, can simultaneously assess cardiac function and myocardial perfusion, and could revolutionize the diagnostic process for intermediate risk patients with chest pain. The superior accuracy of CMR could decrease testing and invasive procedures. The high sensitivity for ongoing ischemia could allow imaging in parallel with cardiac markers. As a result, CMR could improve the care of emergency department (ED) patients with intermediate risk chest pain. However, the efficiency and safety of CMR has not been extensively tested in the CDU setting.
Primary Hypothesis: A CDU-CMR strategy will reduce the occurrence of the composite of revascularization, re-hospitalization, and recurrent cardiac testing at 90 days when compared to an inpatient care strategy.
Methods: Participants (n=146) at intermediate risk for acute coronary syndrome (ACS) will be recruited into a clinical trial from Wake Forest University Baptist Medical Center (WFUBMC) ED. Participants will be equally randomized to CDU-CMR or inpatient care. CDU-CMR participants will undergo resting and stress CMR imaging in parallel with serial cardiac markers. Inpatient care participants will undergo serial cardiac markers followed by existing cardiac testing as determined by their care providers. The primary outcome is the composite of 90 day revascularization, re-hospitalization, and recurrent cardiac testing. The secondary outcome is index hospitalization length of stay. Safety events include ACS after discharge, mortality, and stress testing-related adverse events.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inpatient Care | No intervention | –This is the comparison arm. Patients are admitted to the hospital and undergo usual care. |
| CDU-CMR Protocol | Experimental | Other: Clinical decision unit care, coupled with cardiac MRIPatients will be transferred to the clinical decision unit and undergo a stress cardiac MRI evaluation. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age greater than or equal to 21 years of age at the time of enrollment
- Chest discomfort or other symptoms consistent with possible ACS as indicated by the treating physician after obtaining an ECG and cardiac biomarkers for the patient's evaluation
- Thrombolysis in myocardial infarction (TIMI) risk score >/= 2 or physician impression of intermediate or high likelihood symptoms represent ACS
- Patient requires an inpatient or CDU evaluation for their chest pain
- The treating physician feels the patient could be discharged home if cardiac disease was excluded
Key exclusion criteria (15 listed)
- Elevated cardiac biomarkers
- New ST-segment elevation on any electrocardiogram (>/= 1 mV)
- New ST-segment depression on any electrocardiogram (>/= 2 mV)
- Known inducible cardiac ischemia without subsequent revascularization
- Unable to lie flat
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 |
|---|---|---|
| Clinical decision unit care, coupled with cardiac MRIAfter ED evaluation, patients are randomized to clinical decision unit care or inpatient care. Patients in the clinical decision unit will also undergo a stress cardiac MRI. Patients in the inpatient care arm may undergo any desired testing, including cardiac MRI, as determined by their treating physician. | Other | CDU-CMR Protocol |
Primary outcome
The Composite of Revascularization, Re-hospitalization, and Recurrent Cardiac Testing Through 90 Days.
Time frame: Index Hospitalization through 90 days
4 secondary outcomes
Length of Stay
Time frame: Duration of Index Hospitalization, an average of 1-2 days
Acute Coronary Syndrome
Time frame: Index Hospitalization discharge through 90 days
Mortality
Time frame: Index Hospitalization through 90 days
Stress Testing-related Adverse Event
Time frame: Index Hospitalization through 90 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17194875Rosamond W, Flegal K, Friday G, Furie K, Go A, Greenlund K, Haase N, Ho M, Howard V, Kissela B, Kittner S, Lloyd-Jones D, McDermott M, Meigs J, Moy C, Nichol G, O'Donnell CJ, Roger V, Rumsfeld J, Sorlie P, Steinberger J, Thom T, Wasserthiel-Smoller S, Hong Y; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2007 update: a report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation. 2007 Feb 6;115(5):e69-171. doi: 10.1161/CIRCULATIONAHA.106.179918. Epub 2006 Dec 28. No abstract available.
- Background: PubMed 16841785McCaig LF, Nawar EW. National Hospital Ambulatory Medical Care Survey: 2004 emergency department summary. Adv Data. 2006 Jun 23;(372):1-29.
- Background: PubMed 16387209Christenson J, Innes G, McKnight D, Thompson CR, Wong H, Yu E, Boychuk B, Grafstein E, Rosenberg F, Gin K, Anis A, Singer J. A clinical prediction rule for early discharge of patients with chest pain. Ann Emerg Med. 2006 Jan;47(1):1-10. doi: 10.1016/j.annemergmed.2005.08.007. Epub 2005 Oct 19.
- Background: PubMed 17320744Goldstein JA, Gallagher MJ, O'Neill WW, Ross MA, O'Neil BJ, Raff GL. A randomized controlled trial of multi-slice coronary computed tomography for evaluation of acute chest pain. J Am Coll Cardiol. 2007 Feb 27;49(8):863-71. doi: 10.1016/j.jacc.2006.08.064. Epub 2007 Feb 12.
- Background: PubMed 9862943Farkouh ME, Smars PA, Reeder GS, Zinsmeister AR, Evans RW, Meloy TD, Kopecky SL, Allen M, Allison TG, Gibbons RJ, Gabriel SE. A clinical trial of a chest-pain observation unit for patients with unstable angina. Chest Pain Evaluation in the Emergency Room (CHEER) Investigators. N Engl J Med. 1998 Dec 24;339(26):1882-8. doi: 10.1056/NEJM199812243392603.
- Background: PubMed 9562001Heller GV, Stowers SA, Hendel RC, Herman SD, Daher E, Ahlberg AW, Baron JM, Mendes de Leon CF, Rizzo JA, Wackers FJ. Clinical value of acute rest technetium-99m tetrofosmin tomographic myocardial perfusion imaging in patients with acute chest pain and nondiagnostic electrocardiograms. J Am Coll Cardiol. 1998 Apr;31(5):1011-7. doi: 10.1016/s0735-1097(98)00057-6.
- Background: PubMed 16515429Sprivulis PC, Da Silva JA, Jacobs IG, Frazer AR, Jelinek GA. The association between hospital overcrowding and mortality among patients admitted via Western Australian emergency departments. Med J Aust. 2006 Mar 6;184(5):208-12. doi: 10.5694/j.1326-5377.2006.tb00416.x.
- Background: PubMed 10461551Miro O, Antonio MT, Jimenez S, De Dios A, Sanchez M, Borras A, Milla J. Decreased health care quality associated with emergency department overcrowding. Eur J Emerg Med. 1999 Jun;6(2):105-7. doi: 10.1097/00063110-199906000-00003.
- Background: PubMed 10770981Pope JH, Aufderheide TP, Ruthazer R, Woolard RH, Feldman JA, Beshansky JR, Griffith JL, Selker HP. Missed diagnoses of acute cardiac ischemia in the emergency department. N Engl J Med. 2000 Apr 20;342(16):1163-70. doi: 10.1056/NEJM200004203421603.
- Background: PubMed 12383588Braunwald E, Antman EM, Beasley JW, Califf RM, Cheitlin MD, Hochman JS, Jones RH, Kereiakes D, Kupersmith J, Levin TN, Pepine CJ, Schaeffer JW, Smith EE 3rd, Steward DE, Theroux P, Gibbons RJ, Alpert JS, Faxon DP, Fuster V, Gregoratos G, Hiratzka LF, Jacobs AK, Smith SC Jr; American College of Cardiology; American Heart Association. Committee on the Management of Patients With Unstable Angina. ACC/AHA 2002 guideline update for the management of patients with unstable angina and non-ST-segment elevation myocardial infarction--summary article: a report of the American College of Cardiology/American Heart Association task force on practice guidelines (Committee on the Management of Patients With Unstable Angina). J Am Coll Cardiol. 2002 Oct 2;40(7):1366-74. doi: 10.1016/s0735-1097(02)02336-7. No abstract available.
- Background: PubMed 17075011Hoffmann U, Nagurney JT, Moselewski F, Pena A, Ferencik M, Chae CU, Cury RC, Butler J, Abbara S, Brown DF, Manini A, Nichols JH, Achenbach S, Brady TJ. Coronary multidetector computed tomography in the assessment of patients with acute chest pain. Circulation. 2006 Nov 21;114(21):2251-60. doi: 10.1161/CIRCULATIONAHA.106.634808. Epub 2006 Oct 30.
- Background: PubMed 17267528Hollander JE, Litt HI, Chase M, Brown AM, Kim W, Baxt WG. Computed tomography coronary angiography for rapid disposition of low-risk emergency department patients with chest pain syndromes. Acad Emerg Med. 2007 Feb;14(2):112-6. doi: 10.1197/j.aem.2006.09.051.
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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.
Chadwick Miller, M.D. principal investigator
WFUBMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical decision unit care, coupled with cardiac MRI in people with Acute Coronary Syndrome and Chest Pain, run by Wake Forest University Health Sciences at 1 site 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 7 inclusion and 15 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 10 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 29 Nov 2012). 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?
The Composite of Revascularization, Re-hospitalization, and Recurrent Cardiac Testing Through 90 Days. (time frame: Index Hospitalization through 90 days). 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 NCT01035047, which also lists 56 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 10 Sep 2018.