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ICF in Secondary Prevention of Cardiovascular Disease

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ClinicalTrials.gov Identifier: NCT04590287
Recruitment Status : Completed
First Posted : October 19, 2020
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Poznan University of Medical Sciences

Study Description
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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
Cardiovascular Diseases Secondary Prevention Risk Factor, Cardiovascular

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
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Study Type : Observational [Patient Registry]
Actual Enrollment : 120 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 3 Weeks
Official Title: The Use of ICF Classification System in Secondary Prevention of Cardiovascular Disease Among Others Ischemic and Hemorrhagic Stroke.
Actual Study Start Date : August 15, 2020
Actual Primary Completion Date : October 1, 2020
Actual Study Completion Date : October 1, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
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
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Primary Outcome Measures :
  1. emotional functions [ Time Frame: first examination on admission ]
    symptoms of depression

  2. sleep functions [ Time Frame: first examination on admission ]
    symptoms of insomnia

  3. heart rate [ Time Frame: first examination on admission ]
    heart rate per minute

  4. heart rhythm [ Time Frame: first examination on admission ]
    heart rhythm interpreting ECG (regular or irregular)

  5. functions of arteries [ Time Frame: first examination on admission ]
    carotid stenosis [%]

  6. increased blood pressure [ Time Frame: first examination on admission ]
    blood pressure value [mm/Hg]

  7. functions related to the coagulation of blood. [ Time Frame: first examination on admission ]
    International Normalised Ratio (INR) testing

  8. Glycosylated hemoglobin [ Time Frame: first examination on admission ]
    HbA1c [%]

  9. lipid metabolism. [ Time Frame: first examination on admission ]
    LDL [mg/dL]


Eligibility Criteria
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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
60 patients after ischemic stroke 60 patients after hemorrhagic stroke
Criteria

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
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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): NCT04590287


Locations
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Poland
Department of Rehabilitation and Physiotherapy Rehabilitation,
Poznań, Poland, 61-545
Sponsors and Collaborators
Poznan University of Medical Sciences
Investigators
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Principal Investigator: Ewa Chlebuś, MD Clinic Rehabilitation, University of Medical Sciences in Poznań
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Poznan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT04590287    
Other Study ID Numbers: 4/2020
First Posted: October 19, 2020    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020

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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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Neoplasm Metastasis
Cardiovascular Diseases
Neoplastic Processes
Neoplasms
Pathologic Processes