Multicenter Study to Rule Out Myocardial Infarction by Cardiac Computed Tomography (ROMICAT-II)

This study has been completed.
Sponsor:
Collaborators:
Kaiser Permanente
Beth Israel Deaconess Medical Center
Bay State Clinical Trials, Inc.
Washington University School of Medicine
Tufts Medical Center
The Cleveland Clinic
Northwestern University
University of Maryland
Information provided by (Responsible Party):
Udo Hoffmann, MD MPH, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01084239
First received: January 7, 2010
Last updated: October 22, 2012
Last verified: October 2012

January 7, 2010
October 22, 2012
April 2010
January 2012   (final data collection date for primary outcome measure)
To determine whether length of hospital stay is significantly reduced in the CT arm compared to the comparator arm, that includes other commonly used risk stratification tests (ETT, SPECT, stress ECHO). [ Time Frame: Duration of stay in the hospital during the initial visit ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01084239 on ClinicalTrials.gov Archive Site
  • time to diagnosis [ Time Frame: Duration of stay in the hospital during the initial visit ] [ Designated as safety issue: Yes ]
  • healthcare utilization [ Time Frame: Duration of stay in the hospital during the initial visit and 28 days after enrollment ] [ Designated as safety issue: Yes ]
  • MACE [ Time Frame: Duration of stay in the hospital during the initial visit and 28 days after enrollment ] [ Designated as safety issue: Yes ]
  • cost-effectiveness [ Time Frame: Duration of stay in the hospital during the initial visit and 28 days after enrollment ] [ Designated as safety issue: No ]
  • Rate of ED discharge [ Time Frame: Duration of stay in the hospital during the initial visit ] [ Designated as safety issue: Yes ]
  • time to diagnosis [ Time Frame: Duration of stay in the hospital during the initial visit ] [ Designated as safety issue: Yes ]
  • healthcare utilization [ Time Frame: Duration of stay in the hospital during the initial visit and 28 days after enrollment ] [ Designated as safety issue: Yes ]
  • MACE [ Time Frame: Duration of stay in the hospital during the initial visit, 28 days, 1 year and 2 years after enrollment ] [ Designated as safety issue: Yes ]
  • cost-effectiveness [ Time Frame: Duration of stay in the hospital during the initial visit and 2 years ] [ Designated as safety issue: No ]
  • Rate of ED discharge [ Time Frame: Duration of stay in the hospital during the initial visit ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Multicenter Study to Rule Out Myocardial Infarction by Cardiac Computed Tomography
Rule Out Myocardial Ischemia/Infarction by Computer Assisted Tomography

The growing availability of cardiac computed tomography (CT)* in emergency departments (EDs) across the U.S. expands the opportunities for its clinical application, but also heightens the need to define its appropriate use in the evaluation of patients with acute chest pain. To address this need, we propose to perform a randomized diagnostic trial (RDT) to determine whether integrating cardiac CT, along with the information it provides on coronary artery disease (CAD) and left ventricular (LV) function, can improve the efficiency of the management of these patients (i.e. shorten length of hospital stay, increase direct discharge rates from the ED, decreasing healthcare costs and improving cost effectiveness while being safe).

Patients with acute chest pain and normal or non-diagnostic electrocardiograms (ECGs) represent a cohort whose management is notably inefficient and diagnostically challenging. Because in less than 30% of EDs diagnostic testing (e.g. nuclear imaging, echocardiography, and exercise treadmill ECG) that would allow physicians to rule out the occurrence of myocardial ischemia is performed as part of the initial evaluation, most of these patients are hospitalized for 24 to 36 hours to exclude the presence of acute coronary syndrome (ACS). Of the six million acute chest pain patients admitted each year in the U.S. under these conditions, less than 10% of them ultimately receive a diagnosis of ACS at discharge. Moreover, inpatient care for negative evaluations imparts an economic burden in excess of $8 billion annually.

Since acute myocardial ischemia and necrosis are rare in the absence of coronary artery disease, a technology that reliably identifies CAD may allow physicians to discharge chest pain patients directly from the ED. Cardiac CT is a safe, high-speed, noninvasive imaging technique that accurately detects coronary atherosclerotic plaque and stenosis, and also allows physicians to assess global and regional LV function.

Observational studies have demonstrated that approximately 40% of acute chest pain patients have no evidence of atherosclerosis on cardiac CT, and that an additional 30% have no evidence of hemodynamically significant (>50%) coronary artery stenosis. Both of these criteria are powerful predictors of the absence of both ACS and major adverse cardiovascular events (negative predictive value [NPV] of 98%). The specificity of cardiac CT is further increased when global and regional LV function is normal. Several studies have demonstrated that cardiac CT, with its high NPV, can be effectively used to rule out ACS, but little is known about the willingness ability of ED physicians to use this information to augment patient management.

We therefore propose to perform a trial that will mobilize seven clinical sites and randomize 1000 patients with acute chest pain and normal or non-diagnostic ECGs, to receive either standard ED evaluation (no intervention) or a cardiac CT (experimental) in the evaluation of acute chest pain in the emergency room. (Rule Out Myocardial Infarction using Computer Assisted Computed Tomography [ROMICAT II]).

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Acute Coronary Syndrome
  • Myocardial Infarction
  • Unstable Angina Pectoris
Radiation: Cardiac Computed Tomography
A contrast enhanced cardiac CT will be performed in addition to standard evaluation. Reconstructed data sets will be evaluated for the presence of coronary artery calcium, coronary atherosclerotic plaque and stenosis, LV function and incidental findings.
  • No Intervention: Standard of care
    Subjects in this arm (50% of the total cohort) will continue to receive standard non-invasive evaluation of acute chest pain symptoms in the emergency department - mostly comprising of, but not limited to - exercise treadmill test, stress test with imaging and stress echocardiography.
  • Experimental: Cardiac CT
    Subjects in this arm (50% of the total cohort) will be randomized to receive a cardiac computed tomography scan as part of the initial evaluation of acute chest pain symptoms, upon presentation to the emergency department.
    Intervention: Radiation: Cardiac Computed Tomography

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1000
March 2012
January 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Participant must have at least five minutes of chest pain or equivalent (chest tightness; pain radiating to left, right, or both arms or shoulders, back, neck, epigastrium, jaw/throat; or unexplained shortness of breath, syncope/presyncope, generalized weakness, nausea, or vomiting thought to be of cardiac origin) at rest or during exercise within 24 hours of ED presentation, warranting further risk stratification, as determined by an ED attending.
  2. Participant must have 2 or more cardiac risk factors (diabetes, hypertension, hyperlipidemia, current smoker and family history of coronary artery disease).
  3. Participant must be able to provide a written informed consent.
  4. Participants must be <75 years of age, but >40 years of age.
  5. Participant must be able to hold breath for at least 10 seconds.
  6. Patient must be in sinus rhythm.

Exclusion Criteria:

  1. New diagnostic ischemic ECG changes (ST-segment elevation or depression > 1 mm or T-wave inversion > 4 mm) in more than two anatomically adjacent leads or left bundle branch block
  2. Documented or self-reported history of CAD (MI, percutaneous coronary interventions [PCIs], coronary artery bypass graft [CABG], known significant coronary stenosis [>50%])
  3. Greater than 6 hours since presentation to ED.
  4. BMI >40 kg/m2
  5. Impaired renal function as defined by serum creatinine >1.5 mg/dL*
  6. Elevated troponin-T (> 0.09 ng/ml)
  7. Hemodynamically or clinically unstable condition (BP systolic < 80 mm Hg, atrial or ventricular arrhythmias, persistent chest pain despite adequate therapy)
  8. Known allergy to iodinated contrast agent
  9. Currently symptomatic asthma
  10. Documented or self-reported cocaine use within the past 48 hours (acute)
  11. On Metformin therapy and unable or unwilling to discontinue for 48 hours after the CT scan
  12. Contraindication to beta blockers (taking daily antiasthmatic medication): This exclusion only applies to patients with a heart rate >65 bpm at sites using a non-dual source CT scanner
  13. Participant with no telephone or cell phone numbers or no address (preventing follow-up)
  14. Participant with positive pregnancy test. Women of childbearing potential, defined as <2 years of menopause in the absence of hysterectomy or tube ligation, must have a pregnancy test performed within 24 hours before the CT scan.
  15. Participant unwilling to provide a written informed consent.
Both
40 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01084239
2009P002331
Yes
Udo Hoffmann, MD MPH, Massachusetts General Hospital
Massachusetts General Hospital
  • National Heart, Lung, and Blood Institute (NHLBI)
  • Kaiser Permanente
  • Beth Israel Deaconess Medical Center
  • Bay State Clinical Trials, Inc.
  • Washington University School of Medicine
  • Tufts Medical Center
  • The Cleveland Clinic
  • Northwestern University
  • University of Maryland
Principal Investigator: Udo Hoffmann, MD, MPH Massachusetts General Hospital
Massachusetts General Hospital
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP