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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00547872

Acronym

DADDY-D

Enrollment

400

Registered

2007-10-23

Start date

2007-09-30

Completion date

2012-05-31

Last updated

2012-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease, Diabetes Mellitus

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.

Interventions

PROCEDUREexercise 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to 69 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Death and myocardial infarction	three years

Secondary

Measure	Time frame
Symptomatic heart failure	three years

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026