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

Phase 3

Completed

• Conditions: Coronary Artery Disease; Diabetes Mellitus
• Interventions: Procedure: exercise testing - coronary angiography - revascularization

• Registration Number: NCT00547872
• Lead Sponsor: TURRINI FABRIZIO

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-10-17
• Study First Submitted QC: 2007-10-22
• Study First Posted: 2007-10-23
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-19
• Last Update Posted: 2012-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	exercise testing - coronary angiography - revascularization	Best medical/behavioral treatment according to guidelines suggestions plus CAD screening by ECG tolerance testing followed by revascularization in case of coronary stenosis.

Primary Outcome Measures

Name	Time	Method
Death and myocardial infarction	three years

Secondary Outcome Measures

Name	Time	Method
Symptomatic heart failure	three years

Trial Locations

Locations (1)

Nuovo Ospedale Civile Sant'Agostino Estense; 🇮🇹 Modena, MO, Italy