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OpenTrials
Completed

NCT Number: 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?

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.

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Key information

Age range

50 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Nuovo Ospedale Civile Sant'Agostino Estense

Modena, MO, 41100, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

exercise testing - coronary angiography - revascularization

Procedure

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

Other names: Exercise tolerance testing as screening, Coronary angiography, Revascularization surgical or pecutaneous

Primary outcomes

  1. Death and myocardial infarction

    Time frame: three years

Secondary outcomes

  1. Symptomatic heart failure

    Time frame: three years

Sponsors and collaborators

Lead sponsor

TURRINI FABRIZIO

Other

Registry information

Official study 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

Acronym: DADDY-D

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Oct 23, 2007
Registry last updated
Nov 21, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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