Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Randomized Investigation of Chest Pain Diagnostic Strategies

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Wake Forest Baptist Health
ClinicalTrials.gov Identifier:
NCT01035047
First received: December 17, 2009
Last updated: October 31, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention
Acute Coronary Syndrome
Chest Pain
Other: Clinical decision unit care, coupled with cardiac MRI

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Randomized Investigation of Chest Pain Diagnostic Strategies

Resource links provided by NLM:


Further study details as provided by Wake Forest Baptist Health:

Primary Outcome Measures:
  • The Composite of Revascularization, Re-hospitalization, and Recurrent Cardiac Testing Through 90 Days. [ Time Frame: Index Hospitalization through 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Length of Stay [ Time Frame: Duration of Index Hospitalization, an average of 1-2 days ] [ Designated as safety issue: No ]
  • Acute Coronary Syndrome [ Time Frame: Index Hospitalization discharge through 90 days ] [ Designated as safety issue: Yes ]
  • Mortality [ Time Frame: Index Hospitalization through 90 days ] [ Designated as safety issue: Yes ]
  • Stress Testing-related Adverse Event [ Time Frame: Index Hospitalization through 90 days ] [ Designated as safety issue: Yes ]

Enrollment: 105
Study Start Date: January 2010
Study Completion Date: August 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Inpatient Care
This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
Experimental: CDU-CMR Protocol
Patients will be transferred to the clinical decision unit and undergo a stress cardiac MRI evaluation.
Other: 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.

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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)
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01035047

Locations
United States, North Carolina
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest Baptist Health
Investigators
Principal Investigator: Chadwick Miller, M.D. WFUBMC
  More Information

Additional Information:
Publications:
Committee 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.
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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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

Keywords provided by Wake Forest Baptist Health:
Acute Coronary Syndrome
Chest pain
Cardiac MRI
Risk Stratification
Emergency Department

Additional relevant MeSH terms:
Acute Coronary Syndrome
Chest Pain
Syndrome
Angina Pectoris
Cardiovascular Diseases
Disease
Heart Diseases
Myocardial Ischemia
Pain
Pathologic Processes
Signs and Symptoms
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014