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+<?xml version="1.0" encoding="UTF-8"?>
+<clinical_study rank="188159">
+  <!-- This xml conforms to an XML Schema at:
+    https://clinicaltrials.gov/ct2/html/images/info/public.xsd
+ and an XML DTD at:
+    https://clinicaltrials.gov/ct2/html/images/info/public.dtd -->
+  <required_header>
+    <download_date>ClinicalTrials.gov processed this data on December 16, 2015</download_date>
+    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
+    <url>https://clinicaltrials.gov/show/NCT00162344</url>
+  </required_header>
+  <id_info>
+    <org_study_id>CARDIOLITE-404</org_study_id>
+    <nct_id>NCT00162344</nct_id>
+  </id_info>
+  <brief_title>A Study of Stress Heart Imaging in Patients With Diabetes at Risk for Coronary Disease.</brief_title>
+  <official_title>AceP-D: Non-invasive Assessment of Atypical Chest Pain in Patients With Diabetes</official_title>
+  <sponsors>
+    <lead_sponsor>
+      <agency>Lantheus Medical Imaging</agency>
+      <agency_class>Industry</agency_class>
+    </lead_sponsor>
+  </sponsors>
+  <source>Lantheus Medical Imaging</source>
+  <oversight_info>
+    <authority>United States: Food and Drug Administration</authority>
+  </oversight_info>
+  <brief_summary>
+    <textblock>
+      The study is designed to see if stress heart imaging can be used as a screening exam in
+      patients with diabetes and risk factors of developing of coronary artery disease and
+      experiencing future cardiac events.
+    </textblock>
+  </brief_summary>
+  <overall_status>Completed</overall_status>
+  <start_date>December 2003</start_date>
+  <completion_date type="Actual">December 2005</completion_date>
+  <primary_completion_date type="Actual">December 2005</primary_completion_date>
+  <phase>Phase 4</phase>
+  <study_type>Interventional</study_type>
+  <study_design>Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic</study_design>
+  <primary_outcome>
+    <measure>Examine the prevalence of ischemic heart disease in population of patients with diabetes mellitus and atypical chest pain.</measure>
+  </primary_outcome>
+  <secondary_outcome>
+    <measure>Determine the accuracy of myocardial perfusion imaging (MPI) and exercise tolerance testing (ETT) for the detection of coronary artery disease (CAD) in a subset of patients undergoing clinically indicated coronary angiography.</measure>
+  </secondary_outcome>
+  <secondary_outcome>
+    <measure>Determine the relative value of ETT, Duke Treadmill Score (DTS), MPI, ejection fraction (EF), clinical risk factors, and C-Reactive Protein (CRP) values for identifying patients at risk for cardiac events.</measure>
+  </secondary_outcome>
+  <number_of_arms>1</number_of_arms>
+  <enrollment type="Actual">205</enrollment>
+  <condition>Diabetes</condition>
+  <intervention>
+    <intervention_type>Drug</intervention_type>
+    <intervention_name>Technetium Tc99m Sestamibi</intervention_name>
+  </intervention>
+  <eligibility>
+    <criteria>
+      <textblock>
+        Inclusion Criteria:
+
+          -  History of diabetes for at least 5 years, with a least 2 risk factors (i.e.
+             hypertension, elevated cholesterol levels, history of or current smoker, obese,
+             family history of heart disease) &amp; atypical chest pain.
+
+        Exclusion Criteria:
+
+          -  Typical chest pain being treated with medication, unable to exercise, previous
+             confirmed heart disease
+      </textblock>
+    </criteria>
+    <gender>Both</gender>
+    <minimum_age>18 Years</minimum_age>
+    <maximum_age>76 Years</maximum_age>
+    <healthy_volunteers>No</healthy_volunteers>
+  </eligibility>
+  <overall_official>
+    <last_name>Martin Rosenberg, MD</last_name>
+    <role>Principal Investigator</role>
+    <affiliation>Bristol-Myers Squibb</affiliation>
+  </overall_official>
+  <location>
+    <facility>
+      <name>Local Institution</name>
+      <address>
+        <city>Mission Viejo</city>
+        <state>California</state>
+        <country>United States</country>
+      </address>
+    </facility>
+  </location>
+  <location>
+    <facility>
+      <name>Local Institution</name>
+      <address>
+        <city>Rancho Santa Fe</city>
+        <state>California</state>
+        <country>United States</country>
+      </address>
+    </facility>
+  </location>
+  <location>
+    <facility>
+      <name>Local Institution</name>
+      <address>
+        <city>San Diego</city>
+        <state>California</state>
+        <country>United States</country>
+      </address>
+    </facility>
+  </location>
+  <location>
+    <facility>
+      <name>Local Institution</name>
+      <address>
+        <city>Chicago</city>
+        <state>Illinois</state>
+        <country>United States</country>
+      </address>
+    </facility>
+  </location>
+  <location>
+    <facility>
+      <name>Local Institution</name>
+      <address>
+        <city>Indianapolis</city>
+        <state>Indiana</state>
+        <country>United States</country>
+      </address>
+    </facility>
+  </location>
+  <location>
+    <facility>
+      <name>Local Institution</name>
+      <address>
+        <city>Detroit</city>
+        <state>Michigan</state>
+        <country>United States</country>
+      </address>
+    </facility>
+  </location>
+  <location>
+    <facility>
+      <name>Local Institution</name>
+      <address>
+        <city>Minneapolis</city>
+        <state>Minnesota</state>
+        <country>United States</country>
+      </address>
+    </facility>
+  </location>
+  <location>
+    <facility>
+      <name>Local Institution</name>
+      <address>
+        <city>Albany</city>
+        <state>New York</state>
+        <country>United States</country>
+      </address>
+    </facility>
+  </location>
+  <location>
+    <facility>
+      <name>Local Institution</name>
+      <address>
+        <city>Roslyn</city>
+        <state>New York</state>
+        <country>United States</country>
+      </address>
+    </facility>
+  </location>
+  <location>
+    <facility>
+      <name>Local Institution</name>
+      <address>
+        <city>Columbus</city>
+        <state>Ohio</state>
+        <country>United States</country>
+      </address>
+    </facility>
+  </location>
+  <location>
+    <facility>
+      <name>Local Institution</name>
+      <address>
+        <city>Houston</city>
+        <state>Texas</state>
+        <country>United States</country>
+      </address>
+    </facility>
+  </location>
+  <location>
+    <facility>
+      <name>Local Institution</name>
+      <address>
+        <city>Montreal</city>
+        <state>Quebec</state>
+        <country>Canada</country>
+      </address>
+    </facility>
+  </location>
+  <location_countries>
+    <country>Canada</country>
+    <country>United States</country>
+  </location_countries>
+  <verification_date>April 2011</verification_date>
+  <lastchanged_date>April 14, 2011</lastchanged_date>
+  <firstreceived_date>September 9, 2005</firstreceived_date>
+  <responsible_party>
+    <name_title>Qi Zhu, MD Sr. Medical Director</name_title>
+    <organization>Lantheus Medical Imaging</organization>
+  </responsible_party>
+  <is_fda_regulated>Yes</is_fda_regulated>
+  <is_section_801>Yes</is_section_801>
+  <has_expanded_access>No</has_expanded_access>
+  <intervention_browse>
+    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm  -->
+    <mesh_term>Technetium Tc 99m Sestamibi</mesh_term>
+  </intervention_browse>
+  <!-- Results have not yet been posted for this study                                -->
+</clinical_study>