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

Completed

• Conditions: Critical Limb Ischemia
• Interventions: Procedure: PCI

• Registration Number: NCT01676519
• Lead Sponsor: Ospedale San Donato

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-07
• Primary Completion: 2007-05
• Study Completion: 2011-12
• Status Verified: 2012-08
• Study First Submitted: 2012-08-23
• Study First Submitted QC: 2012-08-30
• Last Update Submitted: 2012-08-30
• Study First Posted: 2012-08-31
• Last Update Posted: 2012-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 764

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PCI	PCI	diabetic patients undergoing percutaneous coronary intervention

Primary Outcome Measures

Name	Time	Method
cardiac mortality rate	4-year follow-up	incidence of cardiac death

Secondary Outcome Measures

Name	Time	Method
major adverse cardiac event rate	4-year follow-up	incidence of major adverse cardiac events (cardiac death, myocardial infarction, target lesion revascularization)

Trial Locations

Locations (1)

Cardiovascular Department, Ospedale S.Donato; 🇮🇹 Arezzo, AR, Italy