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Completed

NCT Number: NCT01676519

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

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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Key information

Conditions

Critical Limb Ischemia Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Chronic Disease Chronic Limb-Threatening Ischemia Disease Attributes Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cardiovascular Department, Ospedale S.Donato

Arezzo, AR, 52100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PCI

Procedure

percutaneous coronary intervention

Primary outcomes

  1. cardiac mortality rate

    Time frame: 4-year follow-up

    incidence of cardiac death

Secondary outcomes

  1. major adverse cardiac event rate

    Time frame: 4-year follow-up

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

Sponsors and collaborators

Lead sponsor

Ospedale San Donato

Other

Registry information

Important dates

Study start
2002
Primary completion
2007
Study completion
2011
First posted
Aug 31, 2012
Registry last updated
Aug 31, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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