Viennese Registry on Patients With Chronic Critical Limb Ischemia
Recruitment status was Recruiting
The rationale of this study is to establish a registry to detect and follow patients with CLI treated in Vienna. The Vienna CLI registry is meant to document the incidence, prevalence, and actual outcome of CLI patients in a real world setting and should serve as a tool for the evaluation of medical, endovascular and surgical interventions. It will help determining the prognosis of individual patients and have impact on economic and political decisions in Vienna concerning this disease and the related costs.
Chronic (> 2 Weeks) Critical Ischemia With Skin Defect in Lower Limbs
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Phase IV Hospital Based Registry to Explore the Outcome of Chronic Critical Limb Ischemia|
- death [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- ipsilateral amputation rate [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- stroke [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- myocardial infarction [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
whole blood, serum, plasma, urine
|Study Start Date:||January 2011|
one group only
This is a prospective observational cohort study including consecutive patients with CLI. The study will be initiated as a single center evaluation and is intended to be step-wise expanded to a Vienna-wide systematic survey. The study will include patients with chronic critical limb ischemia and ischemic ulcerations as defined by Fontaine stage IV or Rutherford stages 5 & 6. The study will include all patients presenting with CLI to the participating centers including inpatients and outpatients.
Patients will be followed up 1 month, 3 months, 6 months, 12 months and then every 6 months. The study will be continued at least until the 5 year data of the last included patient are available.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01233141
|Contact: Silvia Charwat-Resl, MD||+43140400 ext firstname.lastname@example.org|
|Contact: Martin Schillinger, MD||+4340400 ext email@example.com|
|Medical University of Vienna||Recruiting|
|Vienna, Austria, 1090|
|Contact: Silvia Charwat-Resl, MD +43140400 ext 4670 firstname.lastname@example.org|
|Principal Investigator: Silvia Charwat-Resl, MD|