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)

TURRINI FABRIZIO

Status and phase: Completed; Phase 3

Conditions: Coronary Artery Disease; Diabetes Mellitus

Treatments: Procedure: exercise testing - coronary angiography - revascularization

Study type: Interventional

Funder types: Other

Identifiers

NCT00547872

MCV-MO-07-001

Details and patient eligibility

About

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.

Enrollment: 400 patients

Sex: All

Ages: 50 to 69 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

1

Experimental group

Description:

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

Treatment:

Procedure: exercise testing - coronary angiography - revascularization

2

No Intervention group

Description:

Best medical/behavioral treatment according to guidelines suggestions