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

Diabetes Clinical Trial

Official title:

AceP-D: Non-invasive Assessment of Atypical Chest Pain in Patients With Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00162344
• Other study ID #: CARDIOLITE-404
• Status: Completed
• Phase: Phase 4
• First received: September 9, 2005
• Last updated: April 14, 2011
• Start date: December 2003
• Est. completion date: December 2005

Study information

• Verified date: April 2011
• Source: Lantheus Medical Imaging
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 205
• Est. completion date: December 2005
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 76 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Diabetes

Intervention

Drug:
• Technetium Tc99m Sestamibi

Locations

Country	Name	City	State
Canada	Local Institution	Montreal	Quebec
United States	Local Institution	Albany	New York
United States	Local Institution	Chicago	Illinois
United States	Local Institution	Columbus	Ohio
United States	Local Institution	Detroit	Michigan
United States	Local Institution	Houston	Texas
United States	Local Institution	Indianapolis	Indiana
United States	Local Institution	Minneapolis	Minnesota
United States	Local Institution	Mission Viejo	California
United States	Local Institution	Rancho Santa Fe	California
United States	Local Institution	Roslyn	New York
United States	Local Institution	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Lantheus Medical Imaging

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Examine the prevalence of ischemic heart disease in population of patients with diabetes mellitus and atypical chest pain.
Secondary	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.
Secondary	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.