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CompletedNCT01676519Updated Aug 31, 2012

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

An observational study in Critical Limb Ischemia, sponsored by Ospedale San Donato. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-08-31.

Sponsored by Ospedale San Donato · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
764
Ages
18 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Critical Limb Ischemia
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In context

Chronic Limb-Threatening Ischemia

343 studies on the registry are indexed under Chronic Limb-Threatening Ischemia; 70 are open to participants now.

This study's enrollment of 764 is above the median of 123 across 98 observational studies indexed under Chronic Limb-Threatening Ischemia.

Browse Chronic Limb-Threatening Ischemia studies →

Lead sponsor

Ospedale San Donato is the lead sponsor of 25 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

consecutive diabetic patients undergoing percutaneous coronary intervention

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • clinical contraindications to prolonged double antiplatelet therapy
  • life expectancy \< 1 year
  • lack of consent
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
764 participants (actual)

Groups and cohorts

  • PCI

    diabetic patients undergoing percutaneous coronary intervention

    Procedure: PCI

Interventions

  • ProcedurePCI

    percutaneous coronary intervention

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What researchers measure

Primary outcomes

  1. cardiac mortality rate

    incidence of cardiac death

    Time frame: 4-year follow-up

Secondary outcomes

  1. major adverse cardiac event rate

    incidence of major adverse cardiac events (cardiac death, myocardial infarction, target lesion revascularization)

    Time frame: 4-year follow-up

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Study locations

1 site
  • Cardiovascular Department, Ospedale S.Donato
    Arezzo, AR 52100, Italy
08

References and documents

Publications

  • Liistro F, Angioli P, Grotti S, Brandini R, Porto I, Ricci L, Tacconi D, Ducci K, Falsini G, Bellandi G, Bolognese L. Impact of critical limb ischemia on long-term cardiac mortality in diabetic patients undergoing percutaneous coronary revascularization. Diabetes Care. 2013 Jun;36(6):1495-500. doi: 10.2337/dc12-1603. Epub 2013 Jan 22. PubMed 23340882 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 31, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01676519
Lead sponsor
Ospedale San Donato
Responsible party
Leonardo Bolognese, MD (Director, Ospedale San Donato) — Principal investigator
First posted
Aug 31, 2012
Start date
Jul 2002
Primary completion
May 2007
Completion
Dec 2011
Last update
Aug 31, 2012

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.

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