--- a +++ b/matching/trials/NCT00162344.xml @@ -0,0 +1,222 @@ +<?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) & 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>