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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
TURRINI FABRIZIO, Azienda Unita' Sanitaria Locale Di Modena
ClinicalTrials.gov Identifier:
NCT00547872
First received: October 17, 2007
Last updated: November 19, 2012
Last verified: November 2012
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Azienda Unita' Sanitaria Locale Di Modena:

Primary Outcome Measures:
  • Death and myocardial infarction [ Time Frame: three years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Symptomatic heart failure [ Time Frame: three years ] [ Designated as safety issue: Yes ]

Enrollment: 400
Study Start Date: September 2007
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   50 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00547872

Locations
Italy
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
  More Information

Publications:
Responsible Party: TURRINI FABRIZIO, Turrini fabrizio MD, Azienda Unita' Sanitaria Locale Di Modena
ClinicalTrials.gov Identifier: NCT00547872     History of Changes
Other Study ID Numbers: MCV-MO-07-001
Study First Received: October 17, 2007
Last Updated: November 19, 2012
Health Authority: Italy: National Institute of Health

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Diabetes Mellitus
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Heart Diseases
Metabolic Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 21, 2014