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A correction needs to be made to the device's algorithm.
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| Name | Class |
|---|---|
| University of Cincinnati | OTHER |
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A prospective multi-centre observational study to validate the diagnostic accuracy of a transportable magnetocardiograph device for acute coronary syndrome (ACS), focusing on rule-out capability, in patients who present to the emergency department with chest pain symptoms consistent with ACS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chest pain patients presenting to the ED | All patients that present to the emergency department with chest pain and potentially other symptoms consistent with ACS and meet all eligibility criteria will undergo VitalScan Magnetocardiograph. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VitalScan Magnetocardiograph | Device | A passive, non-contact, mobile medical device that measures, displays, stores, and retrieves magnetic fluctuations caused by heart activity at a patient's bedside. |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and specificity of MCG | Sensitivity and specificity for diagnosing ACS, focusing on rule-out, in chest pain patients with normal sinus rhythm | up to 3 month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of adverse events and types | up to 3 month follow-up | |
| All-cause mortatility (divided into CV and non-CV causes) proportion | through 1 week, 3 month follow-up | |
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Inclusion Criteria:
Exclusion Criteria:
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All patients that present to the ED with chest pain syndrome of suspected cardiac origin (i.e. symptoms consistent with ACS) who are in normal sinus rhythm
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| Name | Affiliation | Role |
|---|---|---|
| Gregory J Fermann, MD | University of Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IU Health Methodist Hospital | Indianapolis | Indiana | 46202 | United States | ||
| Wake Forest Baptist Medical Center |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| 3.Change in sensitivity and specificity for diagnosing ACS, focusing on rule-out, in chest pain patients with normal sinus rhythm, according to low, intermediate and high PTP groups |
| up to 3 months follow-up |
| MACE post-presentation to the ED (rule-out of ACS divided into MCG vs reference standard (adjudicated ACS/non-ACS diagnoses)) | through 1 week, 3 month follow-up |
| Winston-Salem |
| North Carolina |
| 27157 |
| United States |
| University of Cincinnati | Cincinnati | Ohio | 45267-0769 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37235 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |