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
  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
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: NCT01676519

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

No publications provided by Ospedale San Donato

Additional 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
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 September 16, 2014