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Multicenter Study to Rule Out Myocardial Infarction by Cardiac Computed Tomography

Rule Out Myocardial Ischemia/Infarction by Computer Assisted Tomography

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01084239
Acronym
ROMICAT-II
Enrollment
1000
Registered
2010-03-10
Start date
2010-04-30
Completion date
2012-03-31
Last updated
2014-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome, Myocardial Infarction, Unstable Angina Pectoris

Keywords

acute chest pain, emergency department, cardiac computed tomography

Brief summary

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).

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 \[ROMICAT II\]).

Interventions

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.

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
Kaiser Permanente
CollaboratorOTHER
Beth Israel Deaconess Medical Center
CollaboratorOTHER
Bay State Clinical Trials, Inc.
CollaboratorOTHER
Washington University School of Medicine
CollaboratorOTHER
Tufts Medical Center
CollaboratorOTHER
The Cleveland Clinic
CollaboratorOTHER
Northwestern University
CollaboratorOTHER
University of Maryland
CollaboratorOTHER
Massachusetts General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Length of Hospital StayDuration of stay in the hospital during the initial visit

Secondary

MeasureTime frameDescription
Time to DiagnosisTime 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 ).
Healthcare UtilizationDuration of stay in the hospital during the initial visitNumber of patients with diagnostic testing (CCTA, ETT, SPECT, stress echocardiography, and invasive coronary angiography)
MACE72 hours after discharge up to 28 days after enrollment.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-effectivenessDuration of stay in the hospital during the initial visitTotal cost during index hospitalization
Rate of ED DischargeDuration of stay in the hospital during the initial visitDirect discharge from Emergency Department

Countries

United States

Participant flow

Recruitment details

Patient enrollment began on April 23, 2010, and ended on January 30, 2012, at nine hospitals in the United States.

Participants by arm

ArmCount
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. 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.
501
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.
499
Total1,000

Withdrawals & dropouts

PeriodReasonFG000FG001
28-Day Follow-upLost to Follow-up49

Baseline characteristics

CharacteristicStandard of CareCardiac CTTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
59 Participants68 Participants127 Participants
Age, Categorical
Between 18 and 65 years
440 Participants433 Participants873 Participants
Age, Continuous54 years
STANDARD_DEVIATION 8
54 years
STANDARD_DEVIATION 8
54 years
STANDARD_DEVIATION 8
Region of Enrollment
United States
499 participants501 participants1000 participants
Sex: Female, Male
Female
229 Participants239 Participants468 Participants
Sex: Female, Male
Male
270 Participants262 Participants532 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
5 / 5011 / 499
serious
Total, serious adverse events
0 / 5010 / 499

Outcome results

Primary

Length of Hospital Stay

Time frame: Duration of stay in the hospital during the initial visit

ArmMeasureValue (MEAN)Dispersion
Cardiac CTLength of Hospital Stay23.2 hoursStandard Deviation 37
Standard of CareLength of Hospital Stay30.8 hoursStandard Deviation 28
Secondary

Cost-effectiveness

Total cost during index hospitalization

Time frame: Duration of stay in the hospital during the initial visit

ArmMeasureValue (MEAN)Dispersion
Cardiac CTCost-effectiveness4026 US DollarsStandard Deviation 6792
Standard of CareCost-effectiveness3874 US DollarsStandard Deviation 5298
Secondary

Healthcare Utilization

Number of patients with diagnostic testing (CCTA, ETT, SPECT, stress echocardiography, and invasive coronary angiography)

Time frame: Duration of stay in the hospital during the initial visit

ArmMeasureValue (NUMBER)
Cardiac CTHealthcare Utilization492 participants
Standard of CareHealthcare Utilization390 participants
p-value: <0.001Fisher Exact
Secondary

MACE

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.

Time frame: 72 hours after discharge up to 28 days after enrollment.

ArmMeasureValue (NUMBER)
Cardiac CTMACE6 events
Standard of CareMACE2 events
Secondary

Rate of ED Discharge

Direct discharge from Emergency Department

Time frame: Duration of stay in the hospital during the initial visit

ArmMeasureValue (NUMBER)
Cardiac CTRate of ED Discharge233 participants
Standard of CareRate of ED Discharge62 participants
Secondary

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 ).

ArmMeasureValue (MEAN)Dispersion
Cardiac CTTime to Diagnosis10.4 hoursStandard Deviation 12.6
Standard of CareTime to Diagnosis18.7 hoursStandard Deviation 11.8

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026