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 Early Recognition Center
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: April 8, 2014
Last verified: April 2014
  Purpose

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 performed 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).


Condition Intervention Phase
Acute Coronary Syndrome
Myocardial Infarction
Unstable Angina Pectoris
Radiation: Cardiac Computed Tomography
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Rule Out Myocardial Ischemia/Infarction by Computer Assisted Tomography

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Length of Hospital Stay [ Time Frame: Duration of stay in the hospital during the initial visit ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time to Diagnosis [ Time Frame: Time from ED arrival to first positive test (all tests except Echocardiography Rest and including troponins ) if discharge diagnosis is ACS, otherwise time to performance of last test (all tests except Echocardiography Rest and including troponins ). ] [ Designated as safety issue: No ]
  • Healthcare Utilization [ Time Frame: Duration of stay in the hospital during the initial visit ] [ Designated as safety issue: Yes ]
    Number of patients with diagnostic testing (CCTA, ETT, SPECT, stress echocardiography, and invasive coronary angiography)

  • MACE [ Time Frame: 72 hours after discharge up to 28 days after enrollment. ] [ Designated as safety issue: No ]
    Major Adverse Cardiovascular Events, All though these events are called MACE they do not qualify as adverse or serious adverse events. As these events are expected in some individuals in this population. Only MACE that occured within 72 hours after hospital discharge were considered serious adverse events in this trial. There were no such events.

  • Cost-effectiveness [ Time Frame: Duration of stay in the hospital during the initial visit ] [ Designated as safety issue: No ]
    Total cost during index hospitalization

  • Rate of ED Discharge [ Time Frame: Duration of stay in the hospital during the initial visit ] [ Designated as safety issue: Yes ]
    Direct discharge from Emergency Department


Enrollment: 1000
Study Start Date: April 2010
Study Completion Date: March 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Standard of care
Subjects in this arm (50% of the total cohort) continued 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) were 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.
Radiation: Cardiac Computed Tomography
A contrast enhanced cardiac CT was performed in addition to standard evaluation. Reconstructed data sets were evaluated for the presence of coronary artery calcium, coronary atherosclerotic plaque and stenosis, LV function and incidental findings.

Detailed Description:

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 performed a trial at 9 clinical sites and randomized 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]).

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Participant had 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. 2 or more cardiac risk factors (diabetes, hypertension, hyperlipidemia, current smoker and family history of coronary artery disease).
  3. Able to provide a written informed consent.
  4. <75 years of age, but >40 years of age.
  5. Able to hold breath for at least 10 seconds.
  6. 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.
  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: NCT01084239

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Kaiser Permanente
Beth Israel Deaconess Medical Center
Bay State Clinical Trials, Inc.
Washington University Early Recognition Center
Tufts Medical Center
The Cleveland Clinic
Northwestern University
University of Maryland
Investigators
Principal Investigator: Udo Hoffmann, MD, MPH Massachusetts General Hospital
  More Information

No publications provided by Massachusetts General Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Udo Hoffmann, MD MPH, Director of Cardiac Imaging, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01084239     History of Changes
Other Study ID Numbers: 2009P002331
Study First Received: January 7, 2010
Results First Received: September 9, 2013
Last Updated: April 8, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
acute chest pain
emergency department
cardiac computed tomography

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

ClinicalTrials.gov processed this record on August 20, 2014