Exercise Testing to Screen for Unknown Coronary Artery Disease in Diabetic Patients: Does it Contribute to a Risk Reduction in Very High Risk Patients?
NCT00547872 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 400
Last updated 2012-11-21
Summary
In the present study a cohort of diabetic patients without any symptoms and without known coronary artery disease (CAD) will be screened at the investigators' diabetes outpatients services. Those with intermediate or high risk will be asked to participate and enrolled. They will be seen and followed by the cardiologists in order to provide the best adherence to medical therapy. By mean of a randomization process, a group of patients will undergo an exercise electrocardiography (ECG) testing while the other group will continue to be regularly seen at the investigators' cardiology service. Those patients with a positive exercise ECG test will be study by coronary angiography and treated according to the severity of coronary lesions by percutaneous stenting or surgery. Both groups of patients will be seen every six-eight months for the next three years.
Conditions
Interventions
- PROCEDURE
-
exercise testing - coronary angiography - revascularization
Those patients with a positive exercise ECG test will be studied by coronary angiography and treated according to the severity of coronary lesions by percutaneous stenting or surgery
Sponsors & Collaborators
-
TURRINI FABRIZIO
lead OTHER
Principal Investigators
-
fabrizio turrini · Azienda Unità Sanitaria Locale di Modena
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 50 Years
- Max Age
- 69 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2007-09-30
- Primary Completion
- 2012-05-31
- Completion
- 2012-05-31
Countries
- Italy
Study Locations
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