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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:
Information provided by (Responsible Party):
Leonardo Bolognese, MD, Ospedale San Donato
ClinicalTrials.gov Identifier:
NCT01676519
First received: August 23, 2012
Last updated: August 30, 2012
Last verified: August 2012
History of Changes
  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 Ospedale San Donato:

Primary Outcome Measures:
  • cardiac mortality rate [ Time Frame: 4-year follow-up ] [ Designated as safety issue: No ]
    incidence of cardiac death


Secondary Outcome Measures:
  • major adverse cardiac event rate [ Time Frame: 4-year follow-up ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01676519

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

No publications provided

Responsible Party: Leonardo Bolognese, MD, Director, Ospedale San Donato
ClinicalTrials.gov Identifier: NCT01676519     History of Changes
Other Study ID Numbers: Arezzo007
Study First Received: August 23, 2012
Last Updated: August 30, 2012
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Ischemia
Pathologic Processes

ClinicalTrials.gov processed this record on June 18, 2013