Cardiovascular DiseasesNCT04590287
ICF in Secondary Prevention of Cardiovascular Disease
An observational study of Cardiovascular Diseases and Secondary Prevention, run by Poznan University of Medical Sciences at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Cardiovascular Diseases, Secondary Prevention, Risk Factor, Cardiovascular
- How many people
- 120 participants
- Where
- 1 sitePoland
- Study dates
- 15 Aug 2020to 1 Oct 2020
- How long will I take part?
- 3 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 60 patients after ischemic stroke 60 patients after hemorrhagic stroke
Who may be able to join
- the first episode of ischemic stroke or hemorrhagic stroke,
- full medical documentation with a description of the above-mentioned risk factors
Who cannot join
- another neurological disease: brain tumor, trauma craniocerebral
- incomplete medical history - no data on assessed risk factors CVD
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Rehabilitation and Physiotherapy Rehabilitation,
Poznan, 61-545
About this study
Official title: 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.
Read the 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.
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
emotional functions
symptoms of depression
Measured: first examination on admission
sleep functions
symptoms of insomnia
Measured: first examination on admission
heart rate
heart rate per minute
Measured: first examination on admission
heart rhythm
heart rhythm interpreting ECG (regular or irregular)
Measured: first examination on admission
functions of arteries
carotid stenosis [%]
Measured: first examination on admission
increased blood pressure
blood pressure value [mm/Hg]
Measured: first examination on admission
functions related to the coagulation of blood.
International Normalised Ratio (INR) testing
Measured: first examination on admission
Glycosylated hemoglobin
HbA1c [%]
Measured: first examination on admission
lipid metabolism.
LDL [mg/dL]
Measured: first examination on admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start15 Aug 2020
- Primary completion1 Oct 2020
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
- Target duration
- 3 Weeks
Sponsor and investigators
- Lead sponsor
- Poznan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ewa Chlebuś, MD, Principal investigator, Clinic Rehabilitation, University of Medical Sciences in Poznań
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04590287
- Sponsor's protocol ID
- 4/2020
- Status last verified
- Oct 2020
- First submitted
- 9 Oct 2020
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34205106
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of ICF Classification System in Secondary Prevention of Cardiovascular Disease Among Others Ischemic and Hemorrhagic Stroke.
- ClinicalTrials.gov ID
- NCT04590287
- Acronym / sponsor ID
- 4/2020
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Poznan University of Medical SciencesUniversity, hospital or other
- Study start
- 15 Aug 2020 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 60 patients after ischemic stroke 60 patients after hemorrhagic stroke
Key inclusion criteria (2 listed)
- the first episode of ischemic stroke or hemorrhagic stroke,
- full medical documentation with a description of the above-mentioned risk factors
Key exclusion criteria (2 listed)
- another neurological disease: brain tumor, trauma craniocerebral
- incomplete medical history - no data on assessed risk factors CVD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
emotional functions
Time frame: first examination on admission
symptoms of depression
sleep functions
Time frame: first examination on admission
symptoms of insomnia
heart rate
Time frame: first examination on admission
heart rate per minute
heart rhythm
Time frame: first examination on admission
heart rhythm interpreting ECG (regular or irregular)
functions of arteries
Time frame: first examination on admission
carotid stenosis [%]
increased blood pressure
Time frame: first examination on admission
blood pressure value [mm/Hg]
functions related to the coagulation of blood.
Time frame: first examination on admission
International Normalised Ratio (INR) testing
Glycosylated hemoglobin
Time frame: first examination on admission
HbA1c [%]
lipid metabolism.
Time frame: first examination on admission
LDL [mg/dL]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Derived from this study: PubMed 34205106Lucki 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ewa Chlebuś, MD principal investigator
Clinic Rehabilitation, University of Medical Sciences in Poznań
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Secondary Prevention, run by Poznan University of Medical Sciences at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
emotional functions (time frame: first examination on admission). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04590287, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020.