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Study never initiated and formally withdrawn with the IRB on 9/14/2023.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coronary Calcium Scoring | Experimental | Coronary calcium scoring by multidetector row computed tomography (MDCT). |
|
| Standard Care | Active Comparator | Standard evaluation of chest pain patient which often includes immediate non-invasive imaging. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coronary Calcium Scoring | Device | Scan with 64-detector row or better CT scanners with quantification by the Agatston method. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Major Adverse Cardiovascular Events | number of patients with death, non-fatal heart attack, non-fatal stroke, non-fatal cardiac arrest | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Stay | emergency department and inpatient | through completion of emergency department stay for each patient, an average of six hours and through completion of hospitalization, an average of two days |
| Measure | Description | Time Frame |
|---|---|---|
| Subsequent Major Adverse Cardiovascular Events | number of patients with death, non-fatal heart attack, non-fatal stroke, non-fatal cardiac arrest | minimum of 6 months |
| Repeat emergency department visits and hospitalizations |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey M Levsky, MD, PhD | Montefiore Medical Center/Albert Einstein College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montefiore Medical Center - Einstein Division | The Bronx | New York | 10461 | United States | ||
| Montefiore Medical Center - Wakefield Division |
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| ID | Term |
|---|---|
| D002637 | Chest Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard Care | Procedure | 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. |
|
number of patients with return visits to the emergency department and hospitalizations after the end of the recruitment visit
| minimum of 6 months |
| Subsequent non-invasive cardiac imaging | number of patients with subsequent stress testing and computed tomography of the heart | minimum of 6 months |
| Subsequent coronary catheterization | number of patients with subsequent conventional angiography of the heart | minimum of 6 months |
| Subsequent percutaneous or surgical coronary revascularization | number of patients with subsequent coronary angioplasty, coronary stenting and bypass surgery | minimum of 6 months |
| Total effective radiation dose | effective radiation dose estimated for procedures involving ionizing radiation | minimum of 6 months |
| The number of patients reporting changes in aspirin pharmacotherapy | patients with new prescriptions for or increased dose of aspirin | minimum of 6 months |
| The number of patients reporting changes in anti-lipid pharmacotherapy | patients with new prescriptions for or increased dose of lipid lowering medication | minimum of 6 months |
| The number of patients reporting persistent chest pain on telephone questionnaire | how many patients report continued chest pain symptoms at follow-up | minimum of 6 months |
| The number of patients with incidental findings due to imaging and the types of findings | how many patients had incidental findings on their heart imaging scans | minimum of 6 months |
| The Bronx |
| New York |
| 10467 |
| United States |