ICF in Secondary Prevention of Cardiovascular Disease

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04590287
• Other study ID #: 4/2020
• Status: Completed
• Start date: August 15, 2020
• Est. completion date: October 1, 2020

Study information

• Verified date: October 2020
• Source: Poznan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: October 1, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Neoplasm Metastasis
• Risk Factor, Cardiovascular
• Secondary Prevention

Locations

Country	Name	City	State
Poland	Department of Rehabilitation and Physiotherapy Rehabilitation,	Poznan

Sponsors (1)

Lead Sponsor	Collaborator
Poznan University of Medical Sciences

Country where clinical trial is conducted

Poland, 

Outcome

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