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NCT03909022 Clinical Trial

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

Peripheral Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03909022
Other study ID # GermanVasc2019_023
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 1, 2008
Est. completion date April 1, 2021

Study information
Verified date April 2020
Source Universitätsklinikum Hamburg-Eppendorf
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 60000
Est. completion date April 1, 2021
Est. primary completion date March 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (3)
Lead Sponsor Collaborator
Universitätsklinikum Hamburg-Eppendorf GermanVasc, MDEpiNet Chapter Germany

References & Publications (3)

Behrendt CA, Sedrakyan A, Peters F, Kreutzburg T, Schermerhorn M, Bertges DJ, Larena-Avellaneda A, L'Hoest H, Kölbel T, Debus ES. Long Term Survival after Femoropopliteal Artery Revascularisation with Paclitaxel Coated Devices: A Propensity Score Matched — View Citation

Kreutzburg T, Peters F, Rieß HC, Hischke S, Marschall U, Kriston L, L'Hoest H, Sedrakyan A, Debus ES, Behrendt CA. Editor's Choice - Comorbidity Patterns Among Patients with Peripheral Arterial Occlusive Disease in Germany: A Trend Analysis of Health Insu — View Citation

Peters F, Kreutzburg T, Kuchenbecker J, Debus ES, Marschall U, L'Hoest H, and Behrendt CA. A retrospective cohort study on the provision and outcomes of pharmacological therapy after revascularisation for peripheral arterial occlusive disease: a study protocolBMJ Surgery, Interventions, & Health Technologies 2020;2:e000020. doi: 10.1136/bmjsit-2019-000020

Outcome
Type Measure Description Time frame Safety issue
Primary Number of participants receiving best-medical-treatment Prevalence 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 at 12 months after discharge
Secondary Number of participants deceased Rate of all-cause mortality after index discharge for POAD according to information provided in health insurance claims at 5 years after discharge
Secondary Lower extremity amputation Rate of lower extremity amputation after index discharge for POAD according to information provided in health insurance claims at 5 years after discharge
Secondary Number of participants with a myocardial infarction Rate of myocardial infarction after index discharge for POAD according to information provided in health insurance claims at 5 years after discharge
Secondary Number of participants with a stroke or transient ischaemic attack Rate of stroke or TIA after index discharge for POAD according to information provided in health insurance claims at 5 years after discharge
Secondary Number of participants with a major bleeding Rate of major bleeding provided in health insurance claims at 5 years after discharge
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