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Sponsors and Collaborators: |
Molecular Targeting Technologies, Inc. National Heart, Lung, and Blood Institute (NHLBI) Yale University University of Pittsburgh |
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Information provided by: | Molecular Targeting Technologies, Inc. |
ClinicalTrials.gov Identifier: | NCT00614354 |
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.
Condition | Intervention | Phase |
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Acute Coronary Syndrome |
Drug: 99mTc-glucarate solution |
Phase II |
Study Type: | Interventional |
Study Design: | Diagnostic, Open Label, Single Group Assignment |
Official Title: | Phase II Study of 99mTc-Glucarate in Chest Pain Patients Suspected With ACS With no Obvious Signs of AMI and With Known Previous CAD. |
Estimated Enrollment: | 100 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: 99mTc-glucarate solution
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
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jeffrey A Mattis, Ph.D. | 610-738-7938 ext 106 | jmattis@mtarget.com |
United States, Connecticut | |
Yale University | Recruiting |
New Haven, Connecticut, United States, 06520 | |
Contact: Albert J. Sinusas, MD 203-785-3155 albert.sinusas@yale.edu | |
Contact: Ajay V. Srivastava, MD 203-412-9571 ajay.v.srivastava@yale.edu | |
Principal Investigator: Albert J. Sinusas, mD | |
Sub-Investigator: Ajay V. Srivastava, MD | |
Sub-Investigator: Raymond Russell, MD, Ph.D. | |
Sub-Investigator: Eli Levine, MD | |
United States, Pennsylvania | |
University of Pittsburgh Medical Center | Recruiting |
Pittsburgh, Pennsylvania, United States, 15213 | |
Contact: Prem Soman, MD, Ph.D. 412-647-3435 somanp@upmc.edu | |
Contact: Aryan Aiyer, MD 412-802-3014 aiyeran@upmc.edu | |
Principal Investigator: Prem Soman, MD, Ph.D. | |
Sub-Investigator: Aryan Aiyer, MD | |
Sub-Investigator: Ferhaan Ahmad, MD, Ph.D. | |
Sub-Investigator: Dustin Kliner, MD |
Principal Investigator: | Albert J. Sinusas, MD | Yale University |
Study Chair: | Diwakar Jain, MD | Drexel University |
Principal Investigator: | Prem Soman, MD, Ph.D. | University of Pittsburgh |
Responsible Party: | Molecular Targeting Technologies, Inc. ( Jeffrey A. Mattis / Sr. VP Scientific and Regulatory Affairs ) |
Study ID Numbers: | MTTI ACS 201 |
Study First Received: | January 30, 2008 |
Last Updated: | December 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00614354 |
Health Authority: | United States: Food and Drug Administration |
99mTc-glucarate imaging to detect acute coronary syndrome |
Heart Diseases Myocardial Ischemia Acute Coronary Syndrome Vascular Diseases |
Pain Ischemia Coronary Artery Disease Chest Pain |
Pathologic Processes Disease Syndrome Cardiovascular Diseases |