<?xml version="1.0" encoding="UTF-8"?>
<clinical_study rank="188159">
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<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) & 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>
