NCT04590287

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

October 9, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 19, 2020

Completed
Last Updated

October 19, 2020

Status Verified

October 1, 2020

Enrollment Period

2 months

First QC Date

October 9, 2020

Last Update Submit

October 9, 2020

Conditions

Outcome Measures

Primary Outcomes (9)

  • emotional functions

    symptoms of depression

    first examination on admission

  • sleep functions

    symptoms of insomnia

    first examination on admission

  • heart rate

    heart rate per minute

    first examination on admission

  • heart rhythm

    heart rhythm interpreting ECG (regular or irregular)

    first examination on admission

  • functions of arteries

    carotid stenosis \[%\]

    first examination on admission

  • increased blood pressure

    blood pressure value \[mm/Hg\]

    first examination on admission

  • functions related to the coagulation of blood.

    International Normalised Ratio (INR) testing

    first examination on admission

  • Glycosylated hemoglobin

    HbA1c \[%\]

    first examination on admission

  • lipid metabolism.

    LDL \[mg/dL\]

    first examination on admission

Study Arms (2)

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.

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

60 patients after ischemic stroke 60 patients after hemorrhagic stroke

You may qualify if:

  • the first episode of ischemic stroke or hemorrhagic stroke,
  • full medical documentation with a description of the above-mentioned risk factors

You may not qualify if:

  • another neurological disease: brain tumor, trauma craniocerebral
  • incomplete medical history - no data on assessed risk factors CVD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Rehabilitation and Physiotherapy Rehabilitation,

Poznan, 61-545, Poland

Location

Related Publications (1)

  • Lucki M, Chlebus E, Warenczak A, Lisinski P. Risk Factors for the Recurrence of CVD Incidents in Post-Stroke Patients over a 5-Year Follow-Up Period Based on the ICF Classification. Int J Environ Res Public Health. 2021 Jun 3;18(11):6021. doi: 10.3390/ijerph18116021.

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Ewa Chlebuś, MD

    Clinic Rehabilitation, University of Medical Sciences in Poznań

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
3 Weeks
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2020

First Posted

October 19, 2020

Study Start

August 15, 2020

Primary Completion

October 1, 2020

Study Completion

October 1, 2020

Last Updated

October 19, 2020

Record last verified: 2020-10

Locations