Coronary Restenosis, Diabetes Mellitus, Type 2
Conditions
Brief summary
The purpose of this clinical research study is determine if patients with diabetes that have undergone previous opening of a heart blockage may have a blockage that is not causing any symptoms that may be detected by imaging with Cardiolite.
Interventions
Sponsors
Lantheus Medical Imaging
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Type II Diabetes on medication & angioplasty within the past 6 months.
Exclusion criteria
* Myocardial infarction or repeat angioplasty with the past 5 months. * Unable to perform exercise or pharmacologic stress test.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate symptom-free heart blockages that develop following initial opening in patients with Type II diabetes mellitus based on Cardiolite imaging | — |
Secondary
| Measure | Time frame |
|---|---|
| Determine how often symptom-free heart blockages occur 5-6 months after opening in patients with Type II diabetes mellitus | — |
| Examine the relative value of ejection fraction, summed stress, rest, and difference MPI scores for identifying patients with cardiac events during 18 month follow-up. | — |
| Compare patient hospital and out-patient cost for cardiac care for each group of patients (MPI versus standard care). | — |
Countries
Puerto Rico, United States
Outcome results
None listed