Phase 3
N=1,000
Multicenter Study to Rule Out Myocardial Infarction by Cardiac Computed Tomography
Acute Coronary Syndrome · Myocardial Infarction · Unstable Angina Pectoris
Bottom Line
View on ClinicalTrials.gov: NCT01084239 ↗Enrolled (actual)
1,000
Serious AEs
0.0%
Results posted
May 2014
Primary outcome: Primary: Length of Hospital Stay — 23.2; 30.8 hours
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Cardiac Computed Tomography (Radiation)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Jan 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Length of Hospital Stay |
23.2; 30.8 | — |
| SECONDARY Time to Diagnosis |
10.4; 18.7 | — |
| SECONDARY Healthcare Utilization |
492; 390 | <0.001 sig |
| SECONDARY MACE |
6; 2 | — |
| SECONDARY Cost-effectiveness |
4026; 3874 | — |
| SECONDARY Rate of ED Discharge |
233; 62 | — |
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).
Eligibility Criteria
Inclusion Criteria
- 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 or more cardiac risk factors (diabetes, hypertension, hyperlipidemia, current smoker and family history of coronary artery disease).
- Able to provide a written informed consent.
- 40 years of age.
- Able to hold breath for at least 10 seconds.
- Sinus rhythm.
Exclusion Criteria
- 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
- Documented or self-reported history of CAD (MI, percutaneous coronary interventions [PCIs], coronary artery bypass graft [CABG], known significant coronary stenosis [>50%])
- Greater than 6 hours since presentation to ED.
- BMI >40 kg/m2
- Impaired renal function as defined by serum creatinine >1.5 mg/dL*
- Elevated troponin-T (> 0.09 ng/ml)
- Hemodynamically or clinically unstable condition (BP systolic 65 bpm at sites using a non-dual source CT scanner
- Participant with no telephone or cell phone numbers or no address (preventing follow-up)
- 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.
- Participant unwilling to provide a written informed consent.
Data sourced from ClinicalTrials.gov (NCT01084239). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.