Peripheral Artery DiseaseNCT03909022
Assessing Best Medical Treatment Patterns of Patients With Symptomatic Peripheral Arterial Occlusive Disease in Germany
An observational study of Peripheral Artery Disease and Intermittent Claudication, run by Universitätsklinikum Hamburg-Eppendorf.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peripheral Artery Disease, Intermittent Claudication, Critical Limb Ischemia
- How many people
- 60,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2008to 1 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients older than 18 years of age. Treated in outpatient or inpatient facilities for symptomatic peripheral arterial occlussive disease.
Who may be able to join
None listed.
Who cannot join
- Incomplete information on sex, age, date of hospital discharge
- Less than 5 years of insurance membership before index stay
About this study
Official title: Assessing Best Medical Treatment Patterns of Patients With Symptomatic Peripheral Arterial Occlusive Disease in Germany - A GermanVasc Study
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.
- Medical subject headings
- Peripheral Arterial Disease, Intermittent Claudication, Chronic Limb-Threatening Ischemia
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at 12 months after discharge
Secondary outcomes (5)
Number of participants deceased
Rate of all-cause mortality after index discharge for POAD according to information provided in health insurance claims
Measured: at 5 years after discharge
Lower extremity amputation
Rate of lower extremity amputation after index discharge for POAD according to information provided in health insurance claims
Measured: at 5 years after discharge
Number of participants with a myocardial infarction
Rate of myocardial infarction after index discharge for POAD according to information provided in health insurance claims
Measured: at 5 years after discharge
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
Measured: at 5 years after discharge
Number of participants with a major bleeding
Rate of major bleeding provided in health insurance claims
Measured: at 5 years after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2019
- Study start1 Jan 2008
- Primary completion31 Mar 2021 (estimated)
- Study completion1 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 60,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Collaborators
- GermanVasc, MDEpiNet Chapter Germany
- Responsible party
- Principal investigator, Christian Behrendt, Universitätsklinikum Hamburg-Eppendorf
- Investigators
- Christian-Alexander Behrendt, MD Dr., Principal investigator, University Medical Center Hamburg-Eppendorf, Working Group GermanVasc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03909022
- Sponsor's protocol ID
- GermanVasc2019_023
- Status last verified
- Apr 2020
- First submitted
- 2 Apr 2019
- Last updated
- 14 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Peters F, Kreutzburg T, Kuchenbecker J, Debus S, Marschall U, L'Hoest H, Behrendt CA. A retrospective cohort study on the provision and outcomes of pharmacological therapy after revascularisation for peripheral arterial occlusive disease: a study protocol. BMJ Surg Interv Health Technol. 2020 Jan 27;2(1):e000020. doi: 10.1136/bmjsit-2019-000020. eCollection 2020.
PubMed 35047784Behrendt CA, Sedrakyan A, Peters F, Kreutzburg T, Schermerhorn M, Bertges DJ, Larena-Avellaneda A, L'Hoest H, Kolbel T, Debus ES. Editor's Choice - Long Term Survival after Femoropopliteal Artery Revascularisation with Paclitaxel Coated Devices: A Propensity Score Matched Cohort Analysis. Eur J Vasc Endovasc Surg. 2020 Apr;59(4):587-596. doi: 10.1016/j.ejvs.2019.12.034. Epub 2020 Jan 8.
PubMed 31926836Peters F, Kreutzburg T, Riess HC, Heidemann F, Marschall U, L'Hoest H, Debus ES, Sedrakyan A, Behrendt CA. Editor's Choice - Optimal Pharmacological Treatment of Symptomatic Peripheral Arterial Occlusive Disease and Evidence of Female Patient Disadvantage: An Analysis of Health Insurance Claims Data. Eur J Vasc Endovasc Surg. 2020 Sep;60(3):421-429. doi: 10.1016/j.ejvs.2020.05.001. Epub 2020 Jul 12.
PubMed 32669223Peters F, Kuchenbecker J, Acar L, Marschall U, L'Hoest H, Lareyre F, Spanos K, Behrendt CA. Antithrombotic Treatment Patterns of Patients with Symptomatic Peripheral Arterial Occlusive Disease in Germany: Evidence from Health Insurance Claims Data. J Clin Med. 2022 Sep 16;11(18):5455. doi: 10.3390/jcm11185455.
PubMed 36143102
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Best Medical Treatment Patterns of Patients With Symptomatic Peripheral Arterial Occlusive Disease in Germany - A GermanVasc Study
- ClinicalTrials.gov ID
- NCT03909022
- Acronym / sponsor ID
- GermanVasc2019_023
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60,000 participants (estimated)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Collaborators
- GermanVasc, MDEpiNet Chapter Germany
- Study start
- 1 Jan 2008 (actual)
- Primary completion
- 31 Mar 2021 (estimated)
- Study completion
- 1 Apr 2021 (estimated)
- First posted
- 9 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients older than 18 years of age. Treated in outpatient or inpatient facilities for symptomatic peripheral arterial occlussive disease.
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- Incomplete information on sex, age, date of hospital discharge
- Less than 5 years of insurance membership before index stay
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants receiving best-medical-treatment
Time frame: at 12 months after discharge
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
5 secondary outcomes
Number of participants deceased
Time frame: at 5 years after discharge
Lower extremity amputation
Time frame: at 5 years after discharge
Number of participants with a myocardial infarction
Time frame: at 5 years after discharge
Number of participants with a stroke or transient ischaemic attack
Time frame: at 5 years after discharge
Number of participants with a major bleeding
Time frame: at 5 years after discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2020.
- Background: PubMed 35047784Peters F, Kreutzburg T, Kuchenbecker J, Debus S, Marschall U, L'Hoest H, Behrendt CA. A retrospective cohort study on the provision and outcomes of pharmacological therapy after revascularisation for peripheral arterial occlusive disease: a study protocol. BMJ Surg Interv Health Technol. 2020 Jan 27;2(1):e000020. doi: 10.1136/bmjsit-2019-000020. eCollection 2020.
- Results publication: PubMed 31926836Behrendt CA, Sedrakyan A, Peters F, Kreutzburg T, Schermerhorn M, Bertges DJ, Larena-Avellaneda A, L'Hoest H, Kolbel T, Debus ES. Editor's Choice - Long Term Survival after Femoropopliteal Artery Revascularisation with Paclitaxel Coated Devices: A Propensity Score Matched Cohort Analysis. Eur J Vasc Endovasc Surg. 2020 Apr;59(4):587-596. doi: 10.1016/j.ejvs.2019.12.034. Epub 2020 Jan 8.
- Results publication: PubMed 32669223Peters F, Kreutzburg T, Riess HC, Heidemann F, Marschall U, L'Hoest H, Debus ES, Sedrakyan A, Behrendt CA. Editor's Choice - Optimal Pharmacological Treatment of Symptomatic Peripheral Arterial Occlusive Disease and Evidence of Female Patient Disadvantage: An Analysis of Health Insurance Claims Data. Eur J Vasc Endovasc Surg. 2020 Sep;60(3):421-429. doi: 10.1016/j.ejvs.2020.05.001. Epub 2020 Jul 12.
- Derived from this study: PubMed 36143102Peters F, Kuchenbecker J, Acar L, Marschall U, L'Hoest H, Lareyre F, Spanos K, Behrendt CA. Antithrombotic Treatment Patterns of Patients with Symptomatic Peripheral Arterial Occlusive Disease in Germany: Evidence from Health Insurance Claims Data. J Clin Med. 2022 Sep 16;11(18):5455. doi: 10.3390/jcm11185455.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian-Alexander Behrendt, MD Dr. principal investigator
University Medical Center Hamburg-Eppendorf, Working Group GermanVasc
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Artery Disease and Intermittent Claudication, run by Universitätsklinikum Hamburg-Eppendorf.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants receiving best-medical-treatment (time frame: at 12 months after discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03909022, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2020.