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| ID | Type | Description | Link |
|---|---|---|---|
| 5R44HL062770-06 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| Yale University | OTHER |
| University of Pittsburgh | OTHER |
| University of Alabama at Birmingham |
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The purpose of this clinical trial is to study the ability of a radioactive drug called "Technetium Glucarate" to detect whether the cause of chest pain in patients entering the emergency department with no obvious signs of heart attack is due to a condition called Acute Coronary Syndrome (ACS). The drug will be injected intravenously. After one or two hours the patient will undergo an imaging procedure to detect if the drug has accumulated in the heart. Uptake of the radioactive drug in the heart is indicative of reduced blood flow to the heart.
Acute coronary syndrome encompasses a range of coronary artery diseases, including unstable angina and both ST-segment elevation and non-ST-segment elevation myocardial infarction (MI). Differentiating ACS from noncardiac chest pain remains a challenge in the emergency department (ED). Myocardial perfusion imaging (MPI) for ischemia has been used to rule ACS in or out among chest pain patients with nondiagnostic ECGs upon presentation to the ED. Several studies have shown a high negative predictive value of MPI for ruling out acute ischemia in the emergency setting. Although myocardial imaging with perfusion agents provides important information for risk-stratifying stable post-ACS patients, this method is of limited value in patients with prior history of CAD, since these patients will often have abnormal resting perfusion patterns, thereby precluding the ability to differentiate old infarcts from new ischemic events. 99mTc-glucarate does not detect old MIs and thus should provide an improvement in specificity in the imaging of ACS patients with previous CAD.
This study proposes to extend the evaluation of 99mTc-glucarate imaging by studying its ability to detect ACS in chest pain patients with no obvious signs of AMI but with known CAD, in the setting of the ED. Unlike MPI, 99mTc-glucarate imaging will not detect old MIs, thereby providing an advantage in specificity of the technique.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 99mTc-glucarate solution | Drug | Patients will receive a single 22 - 27 mCi bolus intravenous dose of 99mTc-glucarate solution, as soon as possible after their arrival in the emergency department or the chest pain center |
| Measure | Description | Time Frame |
|---|---|---|
| Readers will assess images as either positive or negative and note the location of uptake. | Immediately and end of enrolement |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Albert J. Sinusas, MD | Yale University | Principal Investigator |
| Diwakar Jain, MD | Drexel University | Study Chair |
| Prem Soman, MD, Ph.D. | University of Pittsburgh | Principal Investigator |
| Ami E Iskandrian, MD | University of Alabama at Birmingham | Principal Investigator |
| Robert S Jones, MD | University Hospitals Cleveland Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Yale University |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 11, 2019 | |
| Reset | Apr 30, 2019 | |
| Release | May 14, 2019 | |
| Reset | Jun 4, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 11, 2019 | Apr 30, 2019 | |||
| May 14, 2019 |
| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| OTHER |
| University Hospitals Cleveland Medical Center | OTHER |
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| New Haven |
| Connecticut |
| 06520 |
| United States |
| University Hospital Case Medical Center | Cleveland | Ohio | 44106 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| Jun 4, 2019 |