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

NCT ID: NCT00547872

Last Updated: 2012-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2012-05-31

Brief Summary

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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

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Conditions

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Coronary Artery Disease Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

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

Group Type EXPERIMENTAL

exercise testing - coronary angiography - revascularization

Intervention Type 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

2

Best medical/behavioral treatment according to guidelines suggestions

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type PROCEDURE

Other Intervention Names

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Exercise tolerance testing as screening Coronary angiography Revascularization surgical or pecutaneous

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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TURRINI FABRIZIO

OTHER

Sponsor Role lead

Responsible Party

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TURRINI FABRIZIO

Turrini fabrizio MD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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fabrizio turrini

Role: PRINCIPAL_INVESTIGATOR

Azienda Unità Sanitaria Locale di Modena

Locations

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Nuovo Ospedale Civile Sant'Agostino Estense

Modena, MO, Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 20030830 (View on PubMed)

Turrini F, Scarlini S, Mannucci C, Messora R, Giovanardi P, Magnavacchi P, Cappelli C, Evandri V, Zanasi A, Romano S, Cavani R, Ghidoni I, Tondi S, Bondi M. Does coronary Atherosclerosis Deserve to be Diagnosed earlY in Diabetic patients? The DADDY-D trial. Screening diabetic patients for unknown coronary disease. Eur J Intern Med. 2015 Jul;26(6):407-13. doi: 10.1016/j.ejim.2015.05.006. Epub 2015 Jun 6.

Reference Type DERIVED
PMID: 26058988 (View on PubMed)

Other Identifiers

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MCV-MO-07-001

Identifier Type: -

Identifier Source: org_study_id