Chest Pain, Symptomatic Ischemic Equivalent
Conditions
Keywords
Hospitalized patients
Brief summary
The current study is designed to have broad generalizability and inform a potential shift toward greater utilization of stress echocardiography with UCA. This will be accomplished by comparing UCA stress echocardiography with myocardial SPECT among hospitalized patients presenting with atraumatic chest pain. This study seeks to demonstrate: clinical comparability of the 2 modalities (based on non-diagnostic test rates), improved care efficiency (based on length of stay), lower costs, improved provider satisfaction, and a presumed improved safety profile through the elimination of radiation exposure. Primary Hypothesis: A strategy of routine UCA (Optison™) enhanced stress echocardiography will result in a clinically non-diagnostic test rate comparable to myocardial SPECT among patients hospitalized (inpatient or hospital observation status) with atraumatic chest pain.
Interventions
OTHERUCA stress echocardiography or myocardial SPECT
Comparative Effectiveness of cardiac stress imaging modalities
Sponsors
General Electric
Denver Health and Hospital Authority
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients must meet all of the following inclusion criteria to be eligible for participation in this study: 1. Males or females aged ≥ 18 years 2. Evaluated for symptoms of chest discomfort or ischemic equivalent 3. Clinical indication for stress imaging, defined as one of the following clinical risk estimates for CAD based upon the Diamond and Forrester classification7: * Intermediate pretest probability of CAD and electrocardiogram (ECG) is clinically interpretable and patient is able to exercise * Intermediate pretest probability of CAD and ECG is clinically interpretable or patient is unable to exercise * High pretest probability of CAD regardless of ECG interpretability and ability to exercise 4. Willing and able to provide written informed consent to participate in this study 5. Agrees to remain under observation (e.g., inpatient or observational status) until all study procedures from the hospital stay are completed, and to complete a 30-day follow up call
Exclusion criteria
* Patients who meet any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of non-diagnostic tests between ultrasound contrast enhanced stress echocardiography and myocardial SPECT | Within 5 days of stress imaging | Non-diagnostic test rates will be the principal outcome of interest and are defined as those studies that do not allow a clinical decision for patient disposition (alternative non-invasive modality ordered, imaging inadequate to exclude ischemia, target heart rate not achieved, adverse side effects and test was terminated, discharge, further invasive testing such as coronary angiography) or require cardiology consultation for further evaluation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Similarity in rates of cardiac catheterization and acute coronary syndrome events between UCA stress echocardiography and myocardial SPECT | by 30 +/- 7 days post-discharge | * 30-day rates of cardiac catheterization between the two imaging modalities * Difference in the 30-day composite rate of acute coronary syndrome re-hospitalization, revascularization, and death between the two imaging modalities * Similarity in positive predictive value (PPV) of the two imaging modalities * Inter-rater reliability estimates for non-diagnostic echocardiogram studies |
| Shorter length of stay and lower cost of inpatient hospital care for UCA stress echocardiography than for myocardial SPECT | 30 day assesment | * Length of inpatient hospital stay of UCA stress echocardiography versus myocardial SPECT * Difference in time-to-cardiac catheterization beginning from time of admission * Differences in time-to-stress test completion beginning from time of admission30-day hospital costs of UCA stress echocardiography versus myocardial SPECT |
| Greater physician satisfaction when using UCA stress echocardiography than for myocardial SPECT | 5 days | •Physician satisfaction as assessed on questionnaire with UCA stress echocardiography versus myocardial SPECT. Physician(s) will be the provider(s) who supervised patient care during inpatient hospital stay. |
Countries
United States
Outcome results
None listed