Completed

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

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What is being collected

Procedure Data

Collected from today forward - Prospective
Procedure
Who is being recruted

Arterial Occlusive Diseases+10

+ Arteriosclerosis

+ Cardiovascular Diseases

Over 18 Years
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: July 2002
See protocol details

Summary

Principal SponsorOspedale San Donato
Last updated: August 31, 2012
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2002

Actual date on which the first participant was enrolled.

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.

NCT01676519
Principal SponsorOspedale San Donato
Last updated: August 31, 2012
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

764 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Arterial Occlusive DiseasesArteriosclerosisCardiovascular DiseasesChronic DiseaseIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsVascular DiseasesPeripheral Vascular DiseasesDisease AttributesAtherosclerosisPeripheral Arterial DiseaseChronic Limb-Threatening Ischemia

Criteria

3 inclusion criteria required to participate
age > 18 years
diabetes mellitus
need for coronary revascularization
3 exclusion criteria prevent from participating
clinical contraindications to prolonged double antiplatelet therapy
lack of consent
life expectancy < 1 year

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Cardiovascular Department, Ospedale S.Donato

Arezzo, ItalyOpen Cardiovascular Department, Ospedale S.Donato in Google Maps
CompletedOne Study Center