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Randomized Investigation of Chest Pain Diagnostic Strategies

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:
Wake Forest University Baptist Medical Center
ClinicalTrials.gov Identifier:
NCT01035047
First received: December 17, 2009
Last updated: October 31, 2012
Last verified: October 2012
History of Changes
Results First Received: October 31, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Diagnostic
Conditions: Acute Coronary Syndrome
Chest Pain
Intervention: Other: Clinical decision unit care, coupled with cardiac MRI

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment occurred in the Emergency Department (ED) at Wake Forest Baptist Medical Center from March 2010 to June 2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No participants were excluded from the trial prior to treatment assignment.

Reporting Groups
  Description
CDU-CMR Protocol

Patients will be transferred to the clinical decision unit and undergo a stress cardiac MRI evaluation.

Clinical decision unit care, coupled with cardiac MRI : 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.
Inpatient Care This is the comparison arm. Patients are admitted to the hospital and undergo usual care.

Participant Flow:   Overall Study
    CDU-CMR Protocol     Inpatient Care  
STARTED     52     53  
COMPLETED     52     53  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
CDU-CMR Protocol

Patients will be transferred to the clinical decision unit and undergo a stress cardiac MRI evaluation.

Clinical decision unit care, coupled with cardiac MRI : 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.
Inpatient Care This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
Total Total of all reporting groups

Baseline Measures
    CDU-CMR Protocol     Inpatient Care     Total  
Number of Participants  
[units: participants]
 		  52     53     105  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     43     38     81  
>=65 years     9     15     24  
Age  
[units: years]
Median ( Full Range ) 		  54  
  ( 35 to 91 )   		  59  
  ( 40 to 76 )   		  56  
  ( 35 to 91 )  
Gender  
[units: participants]
 		     
Female     24     24     48  
Male     28     29     57  
Ethnicity (NIH/OMB)  
[units: participants]
 		     
Hispanic or Latino     2     0     2  
Not Hispanic or Latino     50     53     103  
Unknown or Not Reported     0     0     0  
Race (NIH/OMB)  
[units: participants]
 		     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     20     15     35  
White     30     38     68  
More than one race     2     0     2  
Unknown or Not Reported     0     0     0  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   The Composite of Revascularization, Re-hospitalization, and Recurrent Cardiac Testing Through 90 Days.   [ Time Frame: Index Hospitalization through 90 days ]
  Show Outcome Measure 1

2.  Secondary:   Length of Stay   [ Time Frame: Duration of Index Hospitalization, an average of 1-2 days ]
  Show Outcome Measure 2

3.  Secondary:   Acute Coronary Syndrome   [ Time Frame: Index Hospitalization discharge through 90 days ]
  Show Outcome Measure 3

4.  Secondary:   Mortality   [ Time Frame: Index Hospitalization through 90 days ]
  Show Outcome Measure 4

5.  Secondary:   Stress Testing-related Adverse Event   [ Time Frame: Index Hospitalization through 90 days ]
  Show Outcome Measure 5


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Erin Harper
Organization: Wake Forest Baptist Medical Center
phone: 336-716-2059
e-mail: erharper@wakehealth.edu


Publications:
Klocke 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. No abstract available.
Patel MR, Dehmer GJ, Hirshfeld JW, Smith PK, Spertus JA; American College of Cardiology Foundation Appropriateness Criteria Task Force; Society for Cardiovascular Angiography and Interventions; Society of Thoracic Surgeons; American Association for Thoracic Surgery; American Heart Association, and the American Society of Nuclear Cardiology Endorsed by the American Society of Echocardiography; Heart Failure Society of America; Society of Cardiovascular Computed Tomography. ACCF/SCAI/STS/AATS/AHA/ASNC 2009 Appropriateness Criteria for Coronary Revascularization: a report by the American College of Cardiology Foundation Appropriateness Criteria Task Force, Society for Cardiovascular Angiography and Interventions, Society of Thoracic Surgeons, American Association for Thoracic Surgery, American Heart Association, and the American Society of Nuclear Cardiology Endorsed by the American Society of Echocardiography, the Heart Failure Society of America, and the Society of Cardiovascular Computed Tomography. J Am Coll Cardiol. 2009 Feb 10;53(6):530-53.
Smith SC Jr, Feldman TE, Hirshfeld JW Jr, Jacobs AK, Kern MJ, King SB 3rd, Morrison DA, O'Neill WW, Schaff HV, Whitlow PL, Williams DO, Antman EM, Smith SC Jr, Adams CD, Anderson JL, Faxon DP, Fuster V, Halperin JL, Hiratzka LF, Hunt SA, Jacobs AK, Nishimura R, Ornato JP, Page RL, Riegel B; American College of Cardiology/American Heart Association Task Force on Practice Guidelines; ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention. ACC/AHA/SCAI 2005 guideline update for percutaneous coronary intervention: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention). J Am Coll Cardiol. 2006 Jan 3;47(1):e1-121. No abstract available.
Anderson JL, Adams CD, Antman EM, Bridges CR, Califf RM, Casey DE Jr, Chavey WE 2nd, Fesmire FM, Hochman JS, Levin TN, Lincoff AM, Peterson ED, Theroux P, Wenger NK, Wright RS, Smith SC Jr, Jacobs AK, Halperin JL, Hunt SA, Krumholz HM, Kushner FG, Lytle BW, Nishimura R, Ornato JP, Page RL, Riegel B; American College of Cardiology; American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines for the Management of Patients With Unstable Angina/Non ST-Elevation Myocardial Infarction); American College of Emergency Physicians; Society for Cardiovascular Angiography and Interventions; Society of Thoracic Surgeons; American Association of Cardiovascular and Pulmonary Rehabilitation; Society for Academic Emergency Medicine. ACC/AHA 2007 guidelines for the management of patients with unstable angina/non ST-elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines for the Management of Patients With Unstable Angina/Non ST-Elevation Myocardial Infarction): developed in collaboration with the American College of Emergency Physicians, the Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons: endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation and the Society for Academic Emergency Medicine. Circulation. 2007 Aug 14;116(7):e148-304. Epub 2007 Aug 6. No abstract available. Erratum in: Circulation. 2008 Mar 4;117(9):e180.
Miller C, Hwang W, Hoekstra J, Lefebvre C, Case D, Hundley WG. Randomized comparison of observation unit plus stress cardiac MRI and hospital admission. Journal of Cardiovascular Magnetic Resonance 2009;11(Suppl 1):O103.
Therneau TM, Grambsch PM, Fleming TR. Martingale-based residuals for survival models 10.1093/biomet/77.1.147. Biometrika 1990;77(1):147-60.


Responsible Party: Chadwick Miller, MD, Wake Forest University Baptist Medical Center
ClinicalTrials.gov Identifier: NCT01035047     History of Changes
Other Study ID Numbers: IRB00010410, 1R21HL097131-01A1
Study First Received: December 17, 2009
Results First Received: October 31, 2012
Last Updated: October 31, 2012
Health Authority: United States: Institutional Review Board
United States: Federal Government