A Study of Stress Heart Imaging in Patients With Diabetes at Risk for Coronary Disease.

This study has been completed.

First Received: September 9, 2005 Last Updated: February 20, 2009 History of Changes

Sponsored by:	Lantheus Medical Imaging
Information provided by:	Lantheus Medical Imaging
ClinicalTrials.gov Identifier:	NCT00162344

Purpose

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.

Condition	Intervention	Phase
Diabetes	Drug: Technetium Tc99m Sestamibi	Phase IV

MedlinePlus related topics: Chest Pain Coronary Artery Disease Diabetes

Drug Information available for: Technetium Tc 99m sestamibi

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	AceP-D: Non-Invasive Assessment of Atypical Chest Pain in Patients With Diabetes

Further study details as provided by Lantheus Medical Imaging:

Primary Outcome Measures:

Examine the prevalence of ischemic heart disease in population of patients with diabetes mellitus and atypical chest pain.

Secondary Outcome Measures:

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.
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.

Estimated Enrollment:	500
Study Start Date:	December 2003

Eligibility

Ages Eligible for Study:	18 Years to 76 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00162344

Locations

United States, California
Local Institution
Rancho Santa Fe, California, United States
Local Institution
Mission Viejo, California, United States
United States, Illinois
Local Institution
Winfield, Illinois, United States
United States, Indiana
Local Institution
Indianapolis, Indiana, United States
United States, Minnesota
Local Institution
St. Paul, Minnesota, United States
United States, New York
Local Institution
Albany, New York, United States
Canada, Quebec
Local Institution
Montreal, Quebec, Canada

Sponsors and Collaborators

Lantheus Medical Imaging

Investigators

Principal Investigator:

Martin Rosenberg, MD

Bristol-Myers Squibb

More Information

No publications provided

Responsible Party:	Lantheus Medical Imaging ( Qi Zhu, MD Sr. Medical Director )
Study ID Numbers:	CARDIOLITE-404
Study First Received:	September 9, 2005
Last Updated:	February 20, 2009
ClinicalTrials.gov Identifier:	NCT00162344 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Coronary Disease
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Stress
Pain

Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
Coronary Artery Disease
Chest Pain

Additional relevant MeSH terms:

Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on May 06, 2009