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ICF in Secondary Prevention of Cardiovascular Disease

Sponsor
Poznan University of Medical Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT04590287
Collaborator
(none)
120
Enrollment
1
Location
1.5
Actual Duration (Months)
77.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study was to develop a practical protocol based on the ICF(The International Classification of Functioning, Disability, and Health) the risk factors of cardiovascular disease (CVD) in secondary prevention.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The original ICF assessment sheet contains CVD risk factor categories, such as comorbidities (depressive disorders, insomnia, heart rhythm and heart rate disorders, carotid artery disease, and hypertension), measures of liver and renal impairment, disorders of carbohydrate and lipid metabolism). The evaluation criteria for each category were determined based on recommendations defined in the ESC, AHA, EFSD, and KIDIGO guidelines.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    120 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    The Use of ICF Classification System in Secondary Prevention of Cardiovascular Disease Among Others Ischemic and Hemorrhagic Stroke.
    Actual Study Start Date :
    Aug 15, 2020
    Actual Primary Completion Date :
    Oct 1, 2020
    Actual Study Completion Date :
    Oct 1, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    Patients after ischemic stroke

    The analysis included the presence of CVD risk factors in patients after ischemic stroke durning in the early rehabilitation.
    Patients after hemorrhagic stroke

    The analysis included the presence of CVD risk factors in patients after hemorrhagic stroke durning in the early rehabilitation.

    Outcome Measures

    Primary Outcome Measures

    1. emotional functions [first examination on admission]

      symptoms of depression

    2. sleep functions [first examination on admission]

      symptoms of insomnia

    3. heart rate [first examination on admission]

      heart rate per minute

    4. heart rhythm [first examination on admission]

      heart rhythm interpreting ECG (regular or irregular)

    5. functions of arteries [first examination on admission]

      carotid stenosis [%]

    6. increased blood pressure [first examination on admission]

      blood pressure value [mm/Hg]

    7. functions related to the coagulation of blood. [first examination on admission]

      International Normalised Ratio (INR) testing

    8. Glycosylated hemoglobin [first examination on admission]

      HbA1c [%]

    9. lipid metabolism. [first examination on admission]

      LDL [mg/dL]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    45 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • the first episode of ischemic stroke or hemorrhagic stroke,

    • full medical documentation with a description of the above-mentioned risk factors

    Exclusion Criteria:

    • another neurological disease: brain tumor, trauma craniocerebral

    • incomplete medical history - no data on assessed risk factors CVD

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Rehabilitation and Physiotherapy Rehabilitation, Poznań Poland 61-545

    Sponsors and Collaborators

    • Poznan University of Medical Sciences

    Investigators

    • Principal Investigator: Ewa Chlebuś, MD, Clinic Rehabilitation, University of Medical Sciences in Poznań

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Poznan University of Medical Sciences
    ClinicalTrials.gov Identifier:
    NCT04590287
    Other Study ID Numbers:
    • 4/2020
    First Posted:
    Oct 19, 2020
    Last Update Posted:
    Oct 19, 2020
    Last Verified:
    Oct 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Neoplasm Metastasis
    Cardiovascular Diseases

    Study Results

    No Results Posted as of Oct 19, 2020