Diabetes
Conditions
Brief 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.
Interventions
Sponsors
Lantheus Medical Imaging
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 76 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Examine the prevalence of ischemic heart disease in population of patients with diabetes mellitus and atypical chest pain. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Canada, United States
Outcome results
None listed