A Study of Stress Heart Imaging in Patients With Diabetes at Risk for Coronary Disease.
AceP-D: Non-invasive Assessment of Atypical Chest Pain in Patients With Diabetes
1 other identifier
interventional
205
2 countries
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 diabetes
Started Dec 2003
Typical duration for phase_4 diabetes
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 9, 2005
CompletedFirst Posted
Study publicly available on registry
September 13, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2005
CompletedApril 15, 2011
April 1, 2011
2 years
September 9, 2005
April 14, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Examine the prevalence of ischemic heart disease in population of patients with diabetes mellitus and atypical chest pain.
Secondary Outcomes (2)
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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Typical chest pain being treated with medication, unable to exercise, previous confirmed heart disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Local Institution
Mission Viejo, California, United States
Local Institution
Rancho Santa Fe, California, United States
Local Institution
San Diego, California, United States
Local Institution
Chicago, Illinois, United States
Local Institution
Indianapolis, Indiana, United States
Local Institution
Detroit, Michigan, United States
Local Institution
Minneapolis, Minnesota, United States
Local Institution
Albany, New York, United States
Local Institution
Roslyn, New York, United States
Local Institution
Columbus, Ohio, United States
Local Institution
Houston, Texas, United States
Local Institution
Montreal, Quebec, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Martin Rosenberg, MD
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 9, 2005
First Posted
September 13, 2005
Study Start
December 1, 2003
Primary Completion
December 1, 2005
Study Completion
December 1, 2005
Last Updated
April 15, 2011
Record last verified: 2011-04