IDOMENEO - Is Treatment Reality in Vascular Medicine Evidence-based and Follows Guideline Recommendations? A Project for Quality Development Exemplified by Peripheral Arterial Disease (PAD)

Universitätsklinikum Hamburg-Eppendorf5,608 enrolled

Overview

The prevalence of peripheral arterial disease (PAD) and the proportion of endovascular procedures for treatment are increasing worldwide. For many cases of treatment or procedures no randomized controlled trials (RCT) or results from meta-analyses are so far available. The decision for treatment and selection of procedure is therefore not uncommonly left up to the personal expertise of the physician. The IDOMENEO study represents a multistage multimethodological project for healthcare research and quality assurance in interdisciplinary vascular medicine, which undertakes a comprehensive examination of this topic. Various methods and data sources (even routine data) are linked in a meaningful way. The essential components of the total project are implementation of a register platform (GermanVasc), which conforms to data protection and data security as well as the development of instruments for valid measurement of the quality of life of patients with PAD. The data protection-conform linking of primary data in the register and routine data of the consortium partner BARMER should also enable validation of the data sources.

Study Type

OBSERVATIONAL

Enrollment

5,608

Conditions

Symptomatic Peripheral Arterial Disease Occlusive Disease of Artery of Lower Extremity Quality of Life

Interventions

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Symptomatic peripheral artery disease (intermittent claudication or critical limb ischemia) * Invasive treatment (open-surgical or endovascular) * Informed consent was obtained Exclusion Criteria: * No informed consent was obtained * Acute limb ischemia without any chronic symptomatic PAD

Locations (35)

Zentralklinik Bad Berka GmbH

Bad Berka, Germany

Herz- und Gefäßzentrum Bad Bevensen

Bad Bevensen, Germany

Universitäts-Herzzentrum Freiburg - Bad Krozingen (UHZ)

Bad Krozingen, Germany

Charité-Universitätsmedizin Berlin, Campus Benjamin Franklin

Berlin, Germany

HELIOS Klinikum Berlin-Buch

Berlin, Germany

Outcomes

Primary Outcomes

All-cause Mortality

Death from any reason

Time frame: 12 Months

Lower Extremity Amputation

Amputation of lower extremity

Time frame: 12 Months

Amputation-free Survival

Long-term-survival without any major amputation

Time frame: 12 Months

Patency of Revascularization

Patency of treated vessel

Time frame: 12 Months

Quality of Life (SF12, WIQ)

Combined questionnaire including 26 questions using QoL-SF12 and Walking Impairment Questionnaire

Time frame: 12 Months

Ambulation

Time frame: 12 Months

Myocardial infarction

Time frame: 12 Months

Stroke or TIA

Time frame: 12 Months

Stent or Graft Thrombosis

Time frame: 12 Months

Functional Status

Time frame: 12 Months

Modified Rutherford Classification

Time frame: 12 Months

Foot Infection

Time frame: 12 Months

Tissue Loss

Time frame: 12 Months

New Revascularization

Time frame: 12 Months

Major Adverse Cardiovascular Events (MACE, MACCE)

Time frame: 12 Months

Major Adverse Limb Events (MALE)

Time frame: 12 Months

Surgical Site Infection

Time frame: 12 Months

Major Bleeding Complication

Time frame: 12 Months

Acute kidney injury (AKI) requiring hemodialysis

As defined by the National Kidney Foundation.