Chest Pain
Conditions
Keywords
chest pain, calcium score, coronary calcium score, coronary calcium scoring, calcium scoring, cacs, ccs
Brief summary
This research asks whether coronary calcium scoring, a non-invasive test based on computed tomography scanning, is a better way to diagnose chest pain patients than other currently used methods. Three of four patients will undergo calcium scoring and the remaining patients will receive standard care.
Interventions
DEVICECoronary Calcium Scoring
Scan with 64-detector row or better CT scanners with quantification by the Agatston method.
PROCEDUREStandard Care
Routine clinical monitoring of chest pain patients. Any of a number of non-invasive cardiac tests such as coronary CT angiography, stress echocardiography and stress radionuclide myocardial perfusion imaging may be performed.
Sponsors
Montefiore Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* complaint of chest pain or pressure * intermediate risk by HEART score * clinical indication for non-invasive cardiac imaging * free of known coronary artery disease
Exclusion criteria
* hemodynamic instability * electrocardiogram suggestive of acute ischemia or myocardial infarction * unremitting chest pain * serum troponin levels greater than three times the laboratory threshold * unable to give his/her own written, informed consent * pregnant women * weight \> 182 kg * unable to lie supine for scan * coronary calcium score, coronary CTA or non-contrast thoracic CT within the last year and available for review * unable to comply with 30 day follow-up
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major Adverse Cardiovascular Events | 30 days | number of patients with death, non-fatal heart attack, non-fatal stroke, non-fatal cardiac arrest |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of Stay | through completion of emergency department stay for each patient, an average of six hours and through completion of hospitalization, an average of two days | emergency department and inpatient |
Other
| Measure | Time frame | Description |
|---|---|---|
| Subsequent non-invasive cardiac imaging | minimum of 6 months | number of patients with subsequent stress testing and computed tomography of the heart |
| Subsequent coronary catheterization | minimum of 6 months | number of patients with subsequent conventional angiography of the heart |
| Subsequent percutaneous or surgical coronary revascularization | minimum of 6 months | number of patients with subsequent coronary angioplasty, coronary stenting and bypass surgery |
| Total effective radiation dose | minimum of 6 months | effective radiation dose estimated for procedures involving ionizing radiation |
| Subsequent Major Adverse Cardiovascular Events | minimum of 6 months | number of patients with death, non-fatal heart attack, non-fatal stroke, non-fatal cardiac arrest |
| The number of patients reporting changes in anti-lipid pharmacotherapy | minimum of 6 months | patients with new prescriptions for or increased dose of lipid lowering medication |
| The number of patients reporting persistent chest pain on telephone questionnaire | minimum of 6 months | how many patients report continued chest pain symptoms at follow-up |
| The number of patients with incidental findings due to imaging and the types of findings | minimum of 6 months | how many patients had incidental findings on their heart imaging scans |
| The number of patients reporting changes in aspirin pharmacotherapy | minimum of 6 months | patients with new prescriptions for or increased dose of aspirin |
| Repeat emergency department visits and hospitalizations | minimum of 6 months | number of patients with return visits to the emergency department and hospitalizations after the end of the recruitment visit |
Countries
United States
Outcome results
None listed