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Clinical Trials/NCT00547872
NCT00547872
Completed
Phase 3

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

TURRINI FABRIZIO1 site in 1 country400 target enrollmentSeptember 2007

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Coronary Artery Disease
Sponsor
TURRINI FABRIZIO
Enrollment
400
Locations
1
Primary Endpoint
Death and myocardial infarction
Status
Completed
Last Updated
13 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2007
End Date
May 2012
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor Investigator
Principal Investigator

TURRINI FABRIZIO

Turrini fabrizio MD

Azienda Unita' Sanitaria Locale Di Modena

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

Outcomes

Primary Outcomes

Death and myocardial infarction

Time Frame: three years

Secondary Outcomes

  • Symptomatic heart failure(three years)

Study Sites (1)

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