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

Lantheus Medical Imaging

Status and phase: Completed; Phase 4

Conditions: Diabetes

Treatments: Drug: Technetium Tc99m Sestamibi

Study type: Interventional

Funder types: Industry

Identifiers

NCT00162344

CARDIOLITE-404

Details and patient eligibility

About

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.

Enrollment: 205 patients

Sex: All

Ages: 18 to 76 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)