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

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

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

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.

Best medical/behavioral treatment according to guidelines suggestions plus CAD screening by ECG tolerance testing followed by revascularization in case of coronary stenosis.

Exercise tolerance testing as screening, Coronary angiography, Revascularization surgical or pecutaneous

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

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

Turrini F, Messora R, Giovanardi P, Tondi S, Magnavacchi P, Cavani R, Tosoni G, Cappelli C, Pellegrini E, Romano S, Baldini A, Zennaro RG, Bondi M. Screening asymptomatic patients with diabetes for unknown coronary artery disease: does it reduce risk? An open-label randomized trial comparing a strategy based on exercise testing aimed at revascularization with management based on pharmacological/behavioural treatment of traditional risk factors. DADDY-D Trial (Does coronary Atherosclerosis Deserve to be Diagnosed and treated early in Diabetics?). Trials. 2009 Dec 23;10:119. doi: 10.1186/1745-6215-10-119.

Turrini F, Scarlini S, Mannucci C, Messora R, Giovanardi P, Magnavacchi P, Cappelli C, Evandri V, Zanasi A, Romano S, Cavani R, Ghidoni I, Tondi S, Bondi M. Does coronary Atherosclerosis Deserve to be Diagnosed earlY in Diabetic patients? The DADDY-D trial. Screening diabetic patients for unknown coronary disease. Eur J Intern Med. 2015 Jul;26(6):407-13. doi: 10.1016/j.ejim.2015.05.006. Epub 2015 Jun 6.