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

This study has been completed.
Sponsor:
Information provided by:
Lantheus Medical Imaging
ClinicalTrials.gov Identifier:
NCT00162344
First received: September 9, 2005
Last updated: April 14, 2011
Last verified: April 2011
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: AceP-D: Non-invasive Assessment of Atypical Chest Pain in Patients With Diabetes

Resource links provided by NLM:


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.

Enrollment: 205
Study Start Date: December 2003
Study Completion Date: December 2005
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
Local Institution
Mission Viejo, California, United States
Local Institution
Rancho Santa Fe, California, United States
Local Institution
San Diego, California, United States
United States, Illinois
Local Institution
Chicago, Illinois, United States
United States, Indiana
Local Institution
Indianapolis, Indiana, United States
United States, Michigan
Local Institution
Detroit, Michigan, United States
United States, Minnesota
Local Institution
Minneapolis, Minnesota, United States
United States, New York
Local Institution
Albany, New York, United States
Local Institution
Roslyn, New York, United States
United States, Ohio
Local Institution
Columbus, Ohio, United States
United States, Texas
Local Institution
Houston, Texas, 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: Qi Zhu, MD Sr. Medical Director, Lantheus Medical Imaging
ClinicalTrials.gov Identifier: NCT00162344     History of Changes
Other Study ID Numbers: CARDIOLITE-404
Study First Received: September 9, 2005
Last Updated: April 14, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Technetium Tc 99m Sestamibi
Diagnostic Uses of Chemicals
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiopharmaceuticals

ClinicalTrials.gov processed this record on October 29, 2014