NCT01676519

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
764

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2002

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2002

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
4.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 31, 2012

Completed
Last Updated

August 31, 2012

Status Verified

August 1, 2012

Enrollment Period

4.8 years

First QC Date

August 23, 2012

Last Update Submit

August 30, 2012

Conditions

Critical Limb Ischemia

Outcome Measures

Primary Outcomes (1)

  • cardiac mortality rate

    incidence of cardiac death

    4-year follow-up

Secondary Outcomes (1)

  • major adverse cardiac event rate

    4-year follow-up

Study Arms (1)

PCI

diabetic patients undergoing percutaneous coronary intervention

Procedure: PCI

Interventions

PCIPROCEDURE

percutaneous coronary intervention

PCI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

consecutive diabetic patients undergoing percutaneous coronary intervention

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiovascular Department, Ospedale S.Donato

Arezzo, AR, 52100, Italy

Location

Related Publications (1)

  • 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.

    PMID: 23340882DERIVED

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Peripheral Arterial DiseaseAtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsIschemia

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

August 23, 2012

First Posted

August 31, 2012

Study Start

July 1, 2002

Primary Completion

May 1, 2007

Study Completion

December 1, 2011

Last Updated

August 31, 2012

Record last verified: 2012-08

Locations

IT(1)