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

Coronary Artery Disease Clinical Trial

— DADDY-D  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00547872
• Other study ID #: MCV-MO-07-001
• Status: Completed
• Phase: Phase 3
• First received: October 17, 2007
• Last updated: November 19, 2012
• Start date: September 2007
• Est. completion date: May 2012

Study information

• Verified date: November 2012
• Source: Azienda Unita' Sanitaria Locale Di Modena
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Institute of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 69 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Diabetes Mellitus
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
Italy	Nuovo Ospedale Civile Sant'Agostino Estense	Modena	MO

Sponsors (1)

Lead Sponsor	Collaborator
TURRINI FABRIZIO

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death and myocardial infarction		three years	Yes
Secondary	Symptomatic heart failure		three years	Yes