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

NCT ID: NCT01676519

Last Updated: 2012-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

764 participants

Study Classification

OBSERVATIONAL

Study Start Date

2002-07-31

Study Completion Date

2011-12-31

Brief Summary

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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

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Conditions

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Critical Limb Ischemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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PCI

diabetic patients undergoing percutaneous coronary intervention

PCI

Intervention Type PROCEDURE

percutaneous coronary intervention

Interventions

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PCI

percutaneous coronary intervention

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ospedale San Donato

OTHER

Sponsor Role lead

Responsible Party

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Leonardo Bolognese, MD

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cardiovascular Department, Ospedale S.Donato

Arezzo, AR, Italy

Site Status

Countries

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Italy

References

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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.

Reference Type DERIVED
PMID: 23340882 (View on PubMed)

Other Identifiers

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Arezzo007

Identifier Type: -

Identifier Source: org_study_id