ICF in Secondary Prevention of Cardiovascular Disease

October 9, 2020 updated by: Poznan University of Medical Sciences

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Poznań, Poland, 61-545
        • Department of Rehabilitation and Physiotherapy Rehabilitation,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

43 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

60 patients after ischemic stroke 60 patients after hemorrhagic stroke

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
emotional functions
Time Frame: first examination on admission
symptoms of depression
first examination on admission
sleep functions
Time Frame: first examination on admission
symptoms of insomnia
first examination on admission
heart rate
Time Frame: first examination on admission
heart rate per minute
first examination on admission
heart rhythm
Time Frame: first examination on admission
heart rhythm interpreting ECG (regular or irregular)
first examination on admission
functions of arteries
Time Frame: first examination on admission
carotid stenosis [%]
first examination on admission
increased blood pressure
Time Frame: first examination on admission
blood pressure value [mm/Hg]
first examination on admission
functions related to the coagulation of blood.
Time Frame: first examination on admission
International Normalised Ratio (INR) testing
first examination on admission
Glycosylated hemoglobin
Time Frame: first examination on admission
HbA1c [%]
first examination on admission
lipid metabolism.
Time Frame: first examination on admission
LDL [mg/dL]
first examination on admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Poznan University of Medical Sciences

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2020

Primary Completion (Actual)

October 1, 2020

Study Completion (Actual)

October 1, 2020

Study Registration Dates

First Submitted

October 9, 2020

First Submitted That Met QC Criteria

October 9, 2020

First Posted (Actual)

October 19, 2020

Study Record Updates

Last Update Posted (Actual)

October 19, 2020

Last Update Submitted That Met QC Criteria

October 9, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4/2020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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