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

NCT00547872 | Completed Phase 3 DMC

• 1 other identifier: MCV-MO-07-001
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Death and myocardial infarction

  three years

Secondary Outcomes (1)

• Symptomatic heart failure

  three years

Study Arms (2)

1

EXPERIMENTAL

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

2

NO INTERVENTION

Best medical/behavioral treatment according to guidelines suggestions

Interventions

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

Also known as: Exercise tolerance testing as screening, Coronary angiography, Revascularization surgical or pecutaneous

1

Eligibility Criteria

• Age: 50 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type two Diabetes Mellitus
• Cardiovascular risk equal or higher than 10% according to Italian risk score (www.cuore.iss.it)

You may not qualify if:

• 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

Sponsors & Collaborators

• TURRINI FABRIZIO: lead

Study Sites (1)

Nuovo Ospedale Civile Sant'Agostino Estense

Modena, MO, 41100, Italy

Location

Related Publications (2)

• 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.

  PMID: 20030830 BACKGROUND

• 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.

  PMID: 26058988 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Diabetes Mellitus

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice

Study Officials

• fabrizio turrini

  Azienda Unità Sanitaria Locale di Modena

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Turrini fabrizio MD

Study Record Dates

• First Submitted: October 17, 2007
• First Posted: October 23, 2007
• Study Start: September 1, 2007
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: November 21, 2012

Record last verified: 2012-11

Locations

IT (1)