Clinical trial NCT00547872: Exercise Testing to Screen for Unknown Coronary Artery Disease in Diabetic Patients: Does it Contribute to a Risk Reduction in Very High Risk Patients?
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Coronary Artery Disease
Diabetes Mellitus
Lead sponsor: Azienda Unita' Sanitaria Locale Di Modena
Sponsor class: OTHER
First posted: 2007-10-23
Enrollment: 400
Sex: ALL
Minimum age (years): 50
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Death and myocardial infarction
timeFrame: three years
Secondary outcomes:
measure: Symptomatic heart failure
timeFrame: three years
Other outcomes:
Locations:
city: Modena
country: Italy
facility: Nuovo Ospedale Civile Sant'Agostino Estense
state: MO
Study officials:
affiliation: Azienda Unità Sanitaria Locale di Modena
name: fabrizio turrini
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.