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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01676519

Enrollment

764

Registered

2012-08-31

Start date

2002-07-31

Completion date

2011-12-31

Last updated

2012-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Limb Ischemia

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.

Interventions

PROCEDUREPCI

percutaneous coronary intervention

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
cardiac mortality rate	4-year follow-up	incidence of cardiac death

Secondary

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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026