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Trial record 14 of 279 for:    Best Disease

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

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ClinicalTrials.gov Identifier: NCT03909022
Recruitment Status : Active, not recruiting
First Posted : April 9, 2019
Last Update Posted : April 9, 2019
Sponsor:
Collaborators:
GermanVasc
MDEpiNet Chapter Germany
Information provided by (Responsible Party):
Christian Behrendt, Universitätsklinikum Hamburg-Eppendorf

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 (POAD) 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 POAD 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 POAD-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.

Condition or disease
Peripheral Artery Disease Intermittent Claudication Critical Limb Ischemia

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Study Type : Observational
Estimated Enrollment : 60000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Assessing Best Medical Treatment Patterns of Patients With Symptomatic Peripheral Arterial Occlusive Disease in Germany - A GermanVasc Study
Actual Study Start Date : January 1, 2008
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : April 1, 2021



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Number of participants deceased [ Time Frame: at 5 years after discharge ]
    Rate of all-cause mortality after index discharge for POAD according to information provided in health insurance claims

  2. Lower extremity amputation [ Time Frame: at 5 years after discharge ]
    Rate of lower extremity amputation after index discharge for POAD according to information provided in health insurance claims

  3. Number of participants with a myocardial infarction [ Time Frame: at 5 years after discharge ]
    Rate of myocardial infarction after index discharge for POAD according to information provided in health insurance claims

  4. Number of participants with a stroke or transient ischaemic attack [ Time Frame: at 5 years after discharge ]
    Rate of stroke or TIA after index discharge for POAD according to information provided in health insurance claims

  5. Number of participants with a major bleeding [ Time Frame: at 5 years after discharge ]
    Rate of major bleeding provided in health insurance claims



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients older than 18 years of age. Treated in outpatient or inpatient facilities for symptomatic peripheral arterial occlussive disease.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03909022


Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
GermanVasc
MDEpiNet Chapter Germany
Investigators
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Principal Investigator: Christian-Alexander Behrendt, MD Dr. University Medical Center Hamburg-Eppendorf, Working Group GermanVasc

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Responsible Party: Christian Behrendt, Head of Research Unit GermanVasc and Principal Investigator, Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT03909022     History of Changes
Other Study ID Numbers: GermanVasc2019_023
First Posted: April 9, 2019    Key Record Dates
Last Update Posted: April 9, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Peripheral Arterial Disease
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases
Ischemia
Intermittent Claudication
Pathologic Processes
Atherosclerosis
Arteriosclerosis
Signs and Symptoms