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

Sponsor

TURRINI FABRIZIO (Other)

Overall Status

Completed

CT.gov ID

NCT00547872

Collaborator

(none)

400

Enrollment

Location

Arms

Duration (Months)

7.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease Diabetes Mellitus	Procedure: exercise testing - coronary angiography - revascularization	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

400 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official 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

Study Start Date :

Sep 1, 2007

Actual Primary Completion Date :

May 1, 2012

Actual Study Completion Date :

May 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Best medical/behavioral treatment according to guidelines suggestions plus CAD screening by ECG tolerance testing followed by revascularization in case of coronary stenosis.	Procedure: exercise 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 Other Names: Exercise tolerance testing as screening Coronary angiography Revascularization surgical or pecutaneous
No Intervention: 2 Best medical/behavioral treatment according to guidelines suggestions

Arm

Intervention/Treatment

Experimental: 1

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

Procedure: exercise 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

Other Names:

Exercise tolerance testing as screening

Coronary angiography

Revascularization surgical or pecutaneous

No Intervention: 2

Best medical/behavioral treatment according to guidelines suggestions

Outcome Measures

Primary Outcome Measures

Death and myocardial infarction [three years]

Secondary Outcome Measures

Symptomatic heart failure [three years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 69 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nuovo Ospedale Civile Sant'Agostino Estense	Modena	MO	Italy	41100

Sponsors and Collaborators

TURRINI FABRIZIO

Investigators

Principal Investigator: fabrizio turrini, Azienda Unità Sanitaria Locale di Modena

Study Documents (Full-Text)

None provided.

More Information

Publications

Turrini F, Messora R, Giovanardi P, Tondi S, Magnavacchi P, Cavani R, Tosoni G, Cappelli C, Pellegrini E, Romano S, Baldini A, Zennaro RG, Bondi M. Screening asymptomatic patients with diabetes for unknown coronary artery disease: does it reduce risk? An open-label randomized trial comparing a strategy based on exercise testing aimed at revascularization with management based on pharmacological/behavioural treatment of traditional risk factors. DADDY-D Trial (Does coronary Atherosclerosis Deserve to be Diagnosed and treated early in Diabetics?). Trials. 2009 Dec 23;10:119. doi: 10.1186/1745-6215-10-119.

Responsible Party:

TURRINI FABRIZIO, Turrini fabrizio MD, Azienda Unita' Sanitaria Locale Di Modena

ClinicalTrials.gov Identifier:

NCT00547872

Other Study ID Numbers:

MCV-MO-07-001

First Posted:

Oct 23, 2007

Last Update Posted:

Nov 21, 2012

Last Verified:

Nov 1, 2012

Additional relevant MeSH terms:

Coronary Artery Disease

Myocardial Ischemia

Coronary Disease

Study Results

No Results Posted as of Nov 21, 2012