Acute Coronary SyndromeNCT00678639
Cost Comparison of Cardiac Magnetic Resonance Imaging (MRI) Use in Emergency Department (ED) Patients With Chest Pain
A study testing Observation 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
The purpose of this study is to investigate the best way to evaluate patients with chest pain in the emergency department. It compares receiving treatment in an observation unit with admission to the hospital. Patients treated in the observation unit will undergo cardiac Magnetic Resonance Imaging (MRI) testing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome, Chest Pain
- What is being tested?
- Observation unit care, coupled with cardiac MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Mar 2009
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than or equal to 18 years of age at the time of enrollment
- Chest discomfort or other symptoms consistent with possible Acute Coronary Syndrome (ACS) as indicated by the treating physician after obtaining an Electrocardiogram (ECG) and cardiac biomarkers for the patient's evaluation
- Patient requires an inpatient evaluation for their chest pain
- The treating physician feels the patient could be discharged home if cardiac disease was excluded
- Thrombolysis in Myocardial Infarction (TIMI) risk score ≥ 2 OR physician clinical impression of intermediate or high likelihood that the symptoms represent ACS
- Negative pregnancy test (if sexually active, female, and of childbearing age)
Who cannot join
- Initial troponin I > 1.0 ng/ml
- New ST-segment elevation on any electrocardiogram (≥ 1 mV)
- New ST-segment depression on any electrocardiogram (≥ 2 mV)
- Unable to lie flat
- Hypotension (systolic < 90 mm Hg)
- Contra-indications to MRI(Pacemaker, defibrillator, cerebral aneurysm clips, metallic ocular foreign body, implanted devices, claustrophobia)
Show all 12Show fewer
- Patient refusal of medical record review and telephone follow-up at 30 days
- Terminal diagnosis with life expectancy less than 3 months
- Pregnancy per patient report or positive pregnancy test (Center for Medicare \& Medicaid Services (CMS) exclusion criteria)
- Renal insufficiency(done prior to enrollment)or end stage renal disease
- Chronic liver disease (ex. hepatitis, cirrhosis)
- History of liver, heart, or kidney transplant
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Baptist Medical Center - Emergency Department
Winston-Salem, North Carolina, 27157
About this study
Official title: Randomized Cost Comparison of Cardiac MRI Use in ED Patients With Chest Pain
The purpose of this study is to investigate the best way to evaluate patients with chest pain in the emergency department. It compares receiving treatment in an observation unit with admission to the hospital. Patients treated in the observation unit will undergo cardiac Magnetic Resonance Imaging (MRI) testing. Patients treated with hospital admission will undergo the testing their doctor determines is best for them. All patients will undergo follow up to find out if they have had any heart related events.
Read the detailed description
Almost half of patients presenting to the Emergency Department (ED) with possible cardiac chest pain are at intermediate risk for short term death or infarction. Most are admitted to the hospital for serial ECG's, cardiac biomarkers, cardiology consultation, and stress testing or coronary angiogram. However, the 2007 ACC/AHA guidelines suggest that these patients can be managed in an observation unit (OU). Recently, cardiac magnetic resonance imaging (CMR) has proven more accurate than traditional testing modalities for the diagnosis of acute coronary syndrome (ACS), and has also received endorsement from the American College of Cardiology (ACC)/American Heart Association (AHA) guidelines. Immediate application of CMR in an OU may improve health care utilization compared to standard hospital admission for intermediate risk patients.
Research hypotheses:
- Patients in an OU CMR protocol will have lower cost for the index hospitalization than standard care.
- An OU CMR protocol for patients with intermediate risk chest pain will significantly improve the frequency of correct cardiovascular admission decisions when compared to standard care.
Methods summary:
110 ED patients at intermediate risk for short-term death or infarction, with nondiagnostic Electrocardiograms (ECG) and normal initial cardiac biomarkers, will be randomized to standard care or OU CMR protocols. Subjects in the OU CMR protocol will undergo CMR perfusion and stress testing, followed by serial biomarkers. Standard care subjects will be admitted for usual cardiac testing. ACS (infarction, death, coronary revascularization, unstable angina) will be assessed by evaluation of hospital course and phone follow-up at 30 days. Cost of hospital care will be compared among groups.
- Conditions
- Acute Coronary Syndrome, Chest Pain
- Being tested
- Observation unit care, coupled with cardiac MRI
- Keywords
- ACS, Acute Coronary Syndrome, Chest pain, Cardiac MRI, CMR, 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.
Observation unit care, coupled with cardiac MRIOther
After Emergency Department (ED) evaluation, patients are randomized to Observation unit care or standard inpatient care. Patients in the observation unit will also undergo a stress cardiac MRI. Patients in the usual care arm may undergo any desired testing, including cardiac MRI, as determined by their treating physician.
| Study group | Role | What they receive |
|---|---|---|
| Emergency Department (ED) Observation unit | Experimental | Emergency Department observation unit- Cardiac Magnetic Resonance Imaging (MRI) Protocol. Patients will be transferred to the observation unit and undergo a stress cardiac MRI evaluation. Receives: Other: Observation unit care, coupled with cardiac MRI |
| Usual care | No intervention | This is the comparison arm. Patients are admitted to the hospital and undergo usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost of Index Hospitalization
Index hospitalization refers to the hospital visit during which the participant was enrolled in the trial. The primary outcome is examining the cost for this visit.
Measured: Emergency Department (ED) arrival through hospital discharge, median length of stay was 28.1 hours
Secondary outcomes (4)
Correct Admission Decision, Based Upon the Reference Standard of Acute Coronary Syndrome (ACS) at 30 Days
Participants with ACS and admitted or not experiencing ACS and discharged will be considered a correct admission decision. Remaining participants will be considered to have incorrect admission decisions.
Measured: 30 Days
The Number of Participants Randomized to the OU and Were Able to Complete CMR Imaging
The number of participants able to complete the planned imaging sequences will be measured.
Measured: Emergency Department (ED) arrival through hospital discharge
Number of Participants Who Utilized the Indicated Health Care Procedures
Measured as self report, assessed during telephone follow-up.
Measured: 30d, 3mo, 6mo, and 1 year
Adverse Events During Magnetic Resonance Imaging (MRI) Scanning
Any event leading to early termination of the MRI acquisition, or requiring intervention by a physician, will be considered an adverse event related to MRI, excluding physician termination of image acquisition due to concerns of cardiac ischemia.
Measured: Occuring in the MRI scanning suite or within 30 minutes of the last image acquisition.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2008 (estimated)
- Study startJan 2008
- Primary completionMar 2009
- Study completionMar 2009
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 (36)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
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chadwick D Miller, MD, Principal investigator, WFUBMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00678639
- Sponsor's protocol ID
- IRB00004120
- Status last verified
- Aug 2018
- First submitted
- 8 May 2008
- Last updated
- 11 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Braunwald 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 12383588Gomberg-Maitland M, Murphy SA, Moliterno DJ, Cannon CP. Are we appropriately triaging patients with unstable angina? Am Heart J. 2005 Apr;149(4):613-8. doi: 10.1016/j.ahj.2004.09.035.
PubMed 15990742Desai AS, Solomon DH, Stone PH, Avorn J. Economic consequences of routine coronary angiography in low- and intermediate-risk patients with unstable angina pectoris. Am J Cardiol. 2003 Aug 15;92(4):363-7. doi: 10.1016/s0002-9149(03)00650-7.
PubMed 12914862Tatum 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 8998090Stowers SA, Eisenstein EL, Th Wackers FJ, Berman DS, Blackshear JL, Jones AD Jr, Szymanski TJ Jr, Lam LC, Simons TA, Natale D, Paige KA, Wagner GS. An economic analysis of an aggressive diagnostic strategy with single photon emission computed tomography myocardial perfusion imaging and early exercise stress testing in emergency department patients who present with chest pain but nondiagnostic electrocardiograms: results from a randomized trial. Ann Emerg Med. 2000 Jan;35(1):17-25. doi: 10.1016/S0196-0644(00)70100-4.
PubMed 10613936Calvin 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 11092647Robinson DJ, Woods PG, Snedeker CA, Lynch JH, Chambers K. A comparison trial for stratifying intermediate-risk chest pain: benefits of emergency department observation centers. Prev Cardiol. 2002 Winter;5(1):23-30. doi: 10.1111/j.1520-037x.2002.00550.x.
PubMed 11872988Committee on the Future of Emergency Care in the United States Health System. 2006. Hospital-Based Emergency Care: At the Breaking Point. Washington, DC: The National Academies Press.
Ramakrishna G, Milavetz JJ, Zinsmeister AR, Farkouh ME, Evans RW, Allison TG, Smars PA, Gibbons RJ. Effect of exercise treadmill testing and stress imaging on the triage of patients with chest pain: CHEER substudy. Mayo Clin Proc. 2005 Mar;80(3):322-9. doi: 10.4065/80.3.322.
PubMed 15757012Conti A, Pieralli F, Sammicheli L, Camaiti A, Vanni S, Grifoni S, Dovellini E, Antoniucci D, Squillantini G, Mazzuoli F, Colombo G. Updated management of non-st-segment elevation acute coronary syndromes: selection of patients for low-cost care: an analysis of outcome and cost effectiveness. Med Sci Monit. 2005 Mar;11(3):CR100-8.
PubMed 15735561Gibbons RJ, Balady GJ, Bricker JT, Chaitman BR, Fletcher GF, Froelicher VF, Mark DB, McCallister BD, Mooss AN, O'Reilly MG, Winters WL Jr. ACC/AHA 2002 guideline update for exercise testing: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee on Exercise Testing). 2002. American College of Cardiology Web site. Available at: www.acc.org/clinical/guidelines/exercise/dirIndex.htm.
Detrano R, Gianrossi R, Froelicher V. The diagnostic accuracy of the exercise electrocardiogram: a meta-analysis of 22 years of research. Prog Cardiovasc Dis. 1989 Nov-Dec;32(3):173-206. doi: 10.1016/0033-0620(89)90025-x. No abstract available.
PubMed 2530605Gianrossi R, Detrano R, Mulvihill D, Lehmann K, Dubach P, Colombo A, McArthur D, Froelicher V. Exercise-induced ST depression in the diagnosis of coronary artery disease. A meta-analysis. Circulation. 1989 Jul;80(1):87-98. doi: 10.1161/01.cir.80.1.87.
PubMed 2661056Geleijnse ML, Fioretti PM, Roelandt JR. Methodology, feasibility, safety and diagnostic accuracy of dobutamine stress echocardiography. J Am Coll Cardiol. 1997 Sep;30(3):595-606. doi: 10.1016/s0735-1097(97)00206-4.
PubMed 9283514Klocke FJ, Baird MG, Lorell BH, Bateman TM, Messer JV, Berman DS, O'Gara PT, Carabello BA, Russell RO Jr, Cerqueira MD, St John Sutton MG, DeMaria AN, Udelson JE, Kennedy JW, Verani MS, Williams KA, Antman EM, Smith SC Jr, Alpert JS, Gregoratos G, Anderson JL, Hiratzka LF, Faxon DP, Hunt SA, Fuster V, Jacobs AK, Gibbons RJ, Russell RO; American College of Cardiology; American Heart Association; American Society for Nuclear Cardiology. ACC/AHA/ASNC guidelines for the clinical use of cardiac radionuclide imaging--executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/ASNC Committee to Revise the 1995 Guidelines for the Clinical Use of Cardiac Radionuclide Imaging). J Am Coll Cardiol. 2003 Oct 1;42(7):1318-33. doi: 10.1016/j.jacc.2003.08.011. No abstract available.
PubMed 14522503
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Cost Comparison of Cardiac MRI Use in ED Patients With Chest Pain
- ClinicalTrials.gov ID
- NCT00678639
- Acronym / sponsor ID
- IRB00004120
- Conditions
- Acute Coronary Syndrome, Chest Pain
- Keywords
- ACS, Acute Coronary Syndrome, Chest pain, Cardiac MRI, CMR, Risk Stratification, Emergency Department
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 15 May 2008 (estimated)
- Results
- Posted 28 Apr 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the best way to evaluate patients with chest pain in the emergency department. It compares receiving treatment in an observation unit with admission to the hospital. Patients treated in the observation unit will undergo cardiac Magnetic Resonance Imaging (MRI) testing. Patients treated with hospital admission will undergo the testing their doctor determines is best for them. All patients will undergo follow up to find out if they have had any heart related events.
Detailed description
Almost half of patients presenting to the Emergency Department (ED) with possible cardiac chest pain are at intermediate risk for short term death or infarction. Most are admitted to the hospital for serial ECG's, cardiac biomarkers, cardiology consultation, and stress testing or coronary angiogram. However, the 2007 ACC/AHA guidelines suggest that these patients can be managed in an observation unit (OU). Recently, cardiac magnetic resonance imaging (CMR) has proven more accurate than traditional testing modalities for the diagnosis of acute coronary syndrome (ACS), and has also received endorsement from the American College of Cardiology (ACC)/American Heart Association (AHA) guidelines. Immediate application of CMR in an OU may improve health care utilization compared to standard hospital admission for intermediate risk patients.
Research hypotheses:
- Patients in an OU CMR protocol will have lower cost for the index hospitalization than standard care.
- An OU CMR protocol for patients with intermediate risk chest pain will significantly improve the frequency of correct cardiovascular admission decisions when compared to standard care.
Methods summary:
110 ED patients at intermediate risk for short-term death or infarction, with nondiagnostic Electrocardiograms (ECG) and normal initial cardiac biomarkers, will be randomized to standard care or OU CMR protocols. Subjects in the OU CMR protocol will undergo CMR perfusion and stress testing, followed by serial biomarkers. Standard care subjects will be admitted for usual cardiac testing. ACS (infarction, death, coronary revascularization, unstable angina) will be assessed by evaluation of hospital course and phone follow-up at 30 days. Cost of hospital care will be compared among groups.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Emergency Department (ED) Observation unit | Experimental | Other: Observation unit care, coupled with cardiac MRIEmergency Department observation unit- Cardiac Magnetic Resonance Imaging (MRI) Protocol. Patients will be transferred to the observation unit and undergo a stress cardiac MRI evaluation. |
| Usual care | No intervention | –This is the comparison arm. Patients are admitted to the hospital and undergo usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age greater than or equal to 18 years of age at the time of enrollment
- Chest discomfort or other symptoms consistent with possible Acute Coronary Syndrome (ACS) as indicated by the treating physician after obtaining an Electrocardiogram (ECG) and cardiac biomarkers for the patient's evaluation
- Patient requires an inpatient evaluation for their chest pain
- The treating physician feels the patient could be discharged home if cardiac disease was excluded
- Thrombolysis in Myocardial Infarction (TIMI) risk score ≥ 2 OR physician clinical impression of intermediate or high likelihood that the symptoms represent ACS
Key exclusion criteria (12 listed)
- Initial troponin I > 1.0 ng/ml
- New ST-segment elevation on any electrocardiogram (≥ 1 mV)
- New ST-segment depression on any electrocardiogram (≥ 2 mV)
- Unable to lie flat
- Hypotension (systolic < 90 mm Hg)
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 |
|---|---|---|
| Observation unit care, coupled with cardiac MRIAfter Emergency Department (ED) evaluation, patients are randomized to Observation unit care or standard inpatient care. Patients in the observation unit will also undergo a stress cardiac MRI. Patients in the usual care arm may undergo any desired testing, including cardiac MRI, as determined by their treating physician. | Other | Emergency Department (ED) Observation unit |
Primary outcome
Cost of Index Hospitalization
Time frame: Emergency Department (ED) arrival through hospital discharge, median length of stay was 28.1 hours
Index hospitalization refers to the hospital visit during which the participant was enrolled in the trial. The primary outcome is examining the cost for this visit.
4 secondary outcomes
Correct Admission Decision, Based Upon the Reference Standard of Acute Coronary Syndrome (ACS) at 30 Days
Time frame: 30 Days
The Number of Participants Randomized to the OU and Were Able to Complete CMR Imaging
Time frame: Emergency Department (ED) arrival through hospital discharge
Number of Participants Who Utilized the Indicated Health Care Procedures
Time frame: 30d, 3mo, 6mo, and 1 year
Adverse Events During Magnetic Resonance Imaging (MRI) Scanning
Time frame: Occuring in the MRI scanning suite or within 30 minutes of the last image acquisition.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 15990742Gomberg-Maitland M, Murphy SA, Moliterno DJ, Cannon CP. Are we appropriately triaging patients with unstable angina? Am Heart J. 2005 Apr;149(4):613-8. doi: 10.1016/j.ahj.2004.09.035.
- Background: PubMed 12914862Desai AS, Solomon DH, Stone PH, Avorn J. Economic consequences of routine coronary angiography in low- and intermediate-risk patients with unstable angina pectoris. Am J Cardiol. 2003 Aug 15;92(4):363-7. doi: 10.1016/s0002-9149(03)00650-7.
- Background: PubMed 8998090Tatum 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.
- Background: PubMed 10613936Stowers SA, Eisenstein EL, Th Wackers FJ, Berman DS, Blackshear JL, Jones AD Jr, Szymanski TJ Jr, Lam LC, Simons TA, Natale D, Paige KA, Wagner GS. An economic analysis of an aggressive diagnostic strategy with single photon emission computed tomography myocardial perfusion imaging and early exercise stress testing in emergency department patients who present with chest pain but nondiagnostic electrocardiograms: results from a randomized trial. Ann Emerg Med. 2000 Jan;35(1):17-25. doi: 10.1016/S0196-0644(00)70100-4.
- Background: PubMed 11092647Calvin 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.
- Background: PubMed 11872988Robinson DJ, Woods PG, Snedeker CA, Lynch JH, Chambers K. A comparison trial for stratifying intermediate-risk chest pain: benefits of emergency department observation centers. Prev Cardiol. 2002 Winter;5(1):23-30. doi: 10.1111/j.1520-037x.2002.00550.x.
- BackgroundCommittee on the Future of Emergency Care in the United States Health System. 2006. Hospital-Based Emergency Care: At the Breaking Point. Washington, DC: The National Academies Press.
- Background: PubMed 15757012Ramakrishna G, Milavetz JJ, Zinsmeister AR, Farkouh ME, Evans RW, Allison TG, Smars PA, Gibbons RJ. Effect of exercise treadmill testing and stress imaging on the triage of patients with chest pain: CHEER substudy. Mayo Clin Proc. 2005 Mar;80(3):322-9. doi: 10.4065/80.3.322.
- Background: PubMed 15735561Conti A, Pieralli F, Sammicheli L, Camaiti A, Vanni S, Grifoni S, Dovellini E, Antoniucci D, Squillantini G, Mazzuoli F, Colombo G. Updated management of non-st-segment elevation acute coronary syndromes: selection of patients for low-cost care: an analysis of outcome and cost effectiveness. Med Sci Monit. 2005 Mar;11(3):CR100-8.
- BackgroundGibbons RJ, Balady GJ, Bricker JT, Chaitman BR, Fletcher GF, Froelicher VF, Mark DB, McCallister BD, Mooss AN, O'Reilly MG, Winters WL Jr. ACC/AHA 2002 guideline update for exercise testing: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee on Exercise Testing). 2002. American College of Cardiology Web site. Available at: www.acc.org/clinical/guidelines/exercise/dirIndex.htm.
- Background: PubMed 2530605Detrano R, Gianrossi R, Froelicher V. The diagnostic accuracy of the exercise electrocardiogram: a meta-analysis of 22 years of research. Prog Cardiovasc Dis. 1989 Nov-Dec;32(3):173-206. doi: 10.1016/0033-0620(89)90025-x. No abstract available.
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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 D Miller, MD 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 Observation 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 6 inclusion and 12 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 11 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 28 Apr 2010). 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?
Cost of Index Hospitalization (time frame: Emergency Department (ED) arrival through hospital discharge, median length of stay was 28.1 hours). 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 NCT00678639, which also lists 36 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 11 Sep 2018.