Exercise Testing to Screen for Unknown Coronary Artery Disease in Diabetic Patients: Does it Contribute to a Risk Reduction in Very High Risk Patients?

Study Overview
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Brief Summary
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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.

Official Title
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Screening Asymptomatic Patients With Diabetes for Unknown Coronary Artery Disease: an Open-label Randomized Study Comparing Exercise Testing Strategy With Management Based on Pharmacological/Behavioral Treatment of Traditional Risk Factors

Conditions
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Diabetes Mellitus, Coronary Artery Disease

Intervention / Treatment
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* Procedure: exercise testing - coronary angiography - revascularization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type two Diabetes Mellitus Cardiovascular risk equal or higher than 10% according to Italian risk score (www.cuore.iss.it) Exclusion Criteria: Known coronary artery disease Symptomatic heart failure Objective inability to perform treadmill exercise Known or active malignancy, advanced renal failure (clearance < 25 ml/mi/1.73m2), liver cirrhosis (child Pugh III); stroke within the past 30 days Presence of left bundle branch block or ST depression at rest greater than 0.9 mm

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Best medical/behavioral treatment according to guidelines suggestions plus CAD screening by ECG tolerance testing followed by revascularization in case of coronary stenosis. | Procedure: exercise testing - coronary angiography - revascularization<br>* 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<br>* Other names: Revascularization surgical or pecutaneous;|
| No Intervention: 2<br>Best medical/behavioral treatment according to guidelines suggestions | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death and myocardial infarction |  | three years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptomatic heart failure |  | three years |