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Impact of Critical Limb Ischemia on Long Term Cardiac Mortality in Diabetic Patients Undergoing Percutaneous Coronary Revascularization

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01676519
First Posted: August 31, 2012
Last Update Posted: August 31, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Leonardo Bolognese, MD, Ospedale San Donato
  Purpose
Prospective cohort study of consecutive diabetic patients undergoing percutaneous coronary intervention (PCI) in whom development of critical limb ischemia was prospectively assessed by a dedicated diabetic foot clinic. Cardiac mortality at 4-year follow-up was the primary endpoint of the study.

Condition Intervention
Critical Limb Ischemia Procedure: PCI

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Further study details as provided by Leonardo Bolognese, MD, Ospedale San Donato:

Primary Outcome Measures:
  • cardiac mortality rate [ Time Frame: 4-year follow-up ]
    incidence of cardiac death


Secondary Outcome Measures:
  • major adverse cardiac event rate [ Time Frame: 4-year follow-up ]
    incidence of major adverse cardiac events (cardiac death, myocardial infarction, target lesion revascularization)


Enrollment: 764
Study Start Date: July 2002
Study Completion Date: December 2011
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
PCI
diabetic patients undergoing percutaneous coronary intervention
Procedure: PCI
percutaneous coronary intervention

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
consecutive diabetic patients undergoing percutaneous coronary intervention
Criteria

Inclusion Criteria:

  • diabetes mellitus
  • need for coronary revascularization
  • age > 18 years

Exclusion Criteria:

  • clinical contraindications to prolonged double antiplatelet therapy
  • life expectancy < 1 year
  • lack of consent
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01676519


Locations
Italy
Cardiovascular Department, Ospedale S.Donato
Arezzo, AR, Italy, 52100
Sponsors and Collaborators
Ospedale San Donato
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Leonardo Bolognese, MD, Director, Ospedale San Donato
ClinicalTrials.gov Identifier: NCT01676519     History of Changes
Other Study ID Numbers: Arezzo007
First Submitted: August 23, 2012
First Posted: August 31, 2012
Last Update Posted: August 31, 2012
Last Verified: August 2012

Additional relevant MeSH terms:
Ischemia
Pathologic Processes