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OpenTrials
Completed

NCT Number: NCT04590287

ICF in Secondary Prevention of Cardiovascular Disease

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.

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Key information

Conditions

Cardiovascular Diseases Risk Factor, Cardiovascular Secondary Prevention

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Rehabilitation and Physiotherapy Rehabilitation,

Poznan, 61-545, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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]

Sponsors and collaborators

Lead sponsor

Poznan University of Medical Sciences

Other

Registry information

Official study title

The Use of ICF Classification System in Secondary Prevention of Cardiovascular Disease Among Others Ischemic and Hemorrhagic Stroke.

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Oct 19, 2020
Registry last updated
Oct 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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