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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 14, 2020
Sponsor:
Collaborators:
GermanVasc
MDEpiNet Chapter Germany
Information provided by (Responsible Party):
Christian Behrendt, Universitätsklinikum Hamburg-Eppendorf

Tracking Information
First Submitted Date April 2, 2019
First Posted Date April 9, 2019
Last Update Posted Date April 14, 2020
Actual Study Start Date January 1, 2008
Estimated Primary Completion Date March 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 7, 2019)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 7, 2019)
  • 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
  • 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
  • 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
  • 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
  • Number of participants with a major bleeding [ Time Frame: at 5 years after discharge ]
    Rate of major bleeding provided in health insurance claims
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Assessing Best Medical Treatment Patterns of Patients With Symptomatic Peripheral Arterial Occlusive Disease in Germany
Official Title Assessing Best Medical Treatment Patterns of Patients With Symptomatic Peripheral Arterial Occlusive Disease in Germany - A GermanVasc Study
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Peripheral Artery Disease
  • Intermittent Claudication
  • Critical Limb Ischemia
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: April 7, 2019)
60000
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 1, 2021
Estimated Primary Completion Date March 31, 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03909022
Other Study ID Numbers GermanVasc2019_023
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Christian Behrendt, Universitätsklinikum Hamburg-Eppendorf
Study Sponsor Universitätsklinikum Hamburg-Eppendorf
Collaborators
  • GermanVasc
  • MDEpiNet Chapter Germany
Investigators
Principal Investigator: Christian-Alexander Behrendt, MD Dr. University Medical Center Hamburg-Eppendorf, Working Group GermanVasc
PRS Account Universitätsklinikum Hamburg-Eppendorf
Verification Date April 2020