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Assessing Best Medical Treatment Patterns of Patients With Symptomatic Peripheral Arterial Occlusive Disease in Germany

Assessing Best Medical Treatment Patterns of Patients With Symptomatic Peripheral Arterial Occlusive Disease in Germany - A GermanVasc Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03909022
Enrollment
60000
Registered
2019-04-09
Start date
2008-01-01
Completion date
2021-04-01
Last updated
2020-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Limb Ischemia, Intermittent Claudication, Peripheral Artery Disease

Brief summary

This proposed study will be conducted to support real-world-evidence on the extent of best medical treatment for secondary prevention of patients with symptomatic peripheral arterial occlusive disease (PAOD) for prevention of worsening limb symptoms or of major adverse cardiovascular events. The overall objective of this study is to gain a better understanding of patient characteristics, treatment patterns and outcomes in PAOD patients. For this purpose the investigators will analyze a patient population hospitalized either with intermittent claudication (IC) or chronic limb-threatening ischaemia (CLTI) while taking prior PAOD-related diagnoses in the outpatient setting into account. In detail, we study differentials according to age, calendar time, sex, disease severity and hospital procedure. Data were extracted from available German health insurance claims.

Interventions

None listed

Sponsors

GermanVasc
CollaboratorOTHER
MDEpiNet Chapter Germany
CollaboratorUNKNOWN
Universitätsklinikum Hamburg-Eppendorf
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

1. First clinical diagnosis of symptomatic peripheral arterial occlusive disease (according to Fontaine classification, stages II, III and IV) after at least 5 years without such clinical diagnosis 2. At least 18 years of age

Exclusion criteria

3. Incomplete information on sex, age, date of hospital discharge 4. Less than 5 years of insurance membership before index stay

Design outcomes

Primary

MeasureTime frameDescription
Number of participants receiving best-medical-treatmentat 12 months after dischargePrevalence of the outpatient prescription of best medical treatment defined as picking up a medication at a pharmacy for a lipid-lowering, an antithrombotic, and an antihypertensive drug agent, within 12 months after index discharge for POAD according to information provided in health insurance claims data

Secondary

MeasureTime frameDescription
Number of participants deceasedat 5 years after dischargeRate of all-cause mortality after index discharge for POAD according to information provided in health insurance claims
Lower extremity amputationat 5 years after dischargeRate of lower extremity amputation after index discharge for POAD according to information provided in health insurance claims
Number of participants with a myocardial infarctionat 5 years after dischargeRate of myocardial infarction after index discharge for POAD according to information provided in health insurance claims
Number of participants with a stroke or transient ischaemic attackat 5 years after dischargeRate of stroke or TIA after index discharge for POAD according to information provided in health insurance claims
Number of participants with a major bleedingat 5 years after dischargeRate of major bleeding provided in health insurance claims

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026