Intellectual Frailty of AgingNCT02224222
Assessment of Frailty as a Risk Factor for Cardiac and Vascular Surgery
An observational study of Intellectual Frailty of Aging and Cardiovascular Diseases, run by Semmelweis University Heart and Vascular Center at 1 site in Hungary.
Trial summary
The purpose of this study is to assess the impact of frailty as a multidimensional risk factor on the outcomes of adult cardiac and vascular surgery. For the purpose of defining patient frailty a multimodal questionnaire has been developed including measurement of psychological, socioeconomical, neurological and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intellectual Frailty of Aging, Cardiovascular Diseases, Myocardial Infarction
- How many people
- 300 participants
- Where
- 1 siteHungary
- Study dates
- Jul 2014to Jul 2020
- How long will I take part?
- 2 Years
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive evaluable patients, 18 years old or older, admitted to Semmelweis University, Heart and Vascular Center for elective cardiac or vascular surgery.
Who may be able to join
- Patients, 18 years or older, admitted to the hospital for elective cardiac or vascular surgery.
Who cannot join
- Not willing to participate.
- Pregnant women.
- During active psychiatric hospital care.
- Patients with defined legal incapability or limited capability.
- Congenital or acquired speech impediment and locomotion disability of any kind.
- Non-evaluable patient due to communication problems and insufficient clinical information for the judgement of frailty (CFS).
- Patients admitted solely for elective surgery of the varices of the lower extremities.
- Patients with a transplanted heart.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to assess the impact of frailty as a multidimensional risk factor on the outcomes of adult cardiac and vascular surgery. For the purpose of defining patient frailty a multimodal questionnaire has been developed including measurement of psychological, socioeconomical, neurological and behavioral aspects. This study also features an investigation of the possible relationship between sudden regional weather changes, individual meteorological susceptibility of the patients and the outcomes of adult cardiac and vascular surgery.
- Conditions
- Intellectual Frailty of Aging, Cardiovascular Diseases, Myocardial Infarction, Vascular Diseases, Heart; Dysfunction Postoperative, Cardiac Surgery
- Medical subject headings
- Cardiovascular Diseases, Myocardial Infarction, Vascular 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 undergoing vascular procedures | Including all non-interventional surgical procedures, excluding varix surgery | |
| Patients undergoing cardiac procedures | Including all non-interventional surgical procedures, excluding HTX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital and intensive care unit stay.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
Secondary outcomes (8)
The composite of in-hospital death from any cause.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
Evidence of clinically definite postoperative acute kidney injury and the need for dialysis.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
Evidence of clinically definite postoperative low cardiac output syndrome.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
Evidence of clinically definite postoperative cardiac arrythmias.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
Evidence of clinically definite postoperative SIRS.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
Evidence of clinically definite postoperative acute lung injury and the need for mechanical ventilation.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
Evidence of clinically definite postoperative peripheral vascular insufficiency.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
The need for reoperation due to bleeding.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2014 (estimated)
- Study startJul 2014
- Primary completionApr 2020 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intellectual Frailty of AgingStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Semmelweis University Heart and Vascular Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Szekely, Semmelweis University
- Investigators
- Andrea Székely, MD, PhD, Study director, Semmelweis University, Department of Anesthesiology and Intensive TherapyDaniel J Lex, MD, Principal investigator, Semmelweis University Heart and Vascular CenterNikoletta Czobor, Principal investigator, Semmelweis UniversityPeter Misnyovszki, Principal investigator, Semmelweis UniversityHanna Tihanyi, Principal investigator, Semmelweis UniversityKalatin Fink, MD, Principal investigator, Semmelweis UniversityBéla Merkely, MD, PhD, DSc, Study chair, Semmelweis UniversityLászló Entz, MD, PhD, Study chair, Semmelweis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02224222
- Sponsor's protocol ID
- VSZÉK-FRAILTY
- Status last verified
- Apr 2019
- First submitted
- 14 Aug 2014
- Last updated
- 9 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Toth K, Szabo A, Nagy A, Szabo D, Szecsi B, Eke C, Sandor A, Susanszky E, Holndonner-Kirst E, Merkely B, Gal J, Szekely A. Preoperative nutritional state is associated with mid- and long-term mortality after cardiac surgery. Ann Palliat Med. 2021 Nov;10(11):11333-11347. doi: 10.21037/apm-21-1015. Epub 2021 Sep 29.
PubMed 34670385Szabo A, Toth K, Nagy A, Domokos D, Czobor N, Eke C, Sandor A, Merkely B, Susanszky E, Gal J, Szekely A. The effect of cognitive dysfunction on mid- and long-term mortality after vascular surgery. BMC Geriatr. 2021 Jan 13;21(1):46. doi: 10.1186/s12877-020-01994-x.
PubMed 33441102
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Frailty as a Risk Factor for Cardiac and Vascular Surgery
- ClinicalTrials.gov ID
- NCT02224222
- Acronym / sponsor ID
- VSZÉK-FRAILTY
- Conditions
- Intellectual Frailty of Aging, Cardiovascular Diseases, Myocardial Infarction, Vascular Diseases, Heart; Dysfunction Postoperative, Cardiac Surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Semmelweis University Heart and Vascular CenterUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 25 Aug 2014 (estimated)
- 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 purpose of this study is to assess the impact of frailty as a multidimensional risk factor on the outcomes of adult cardiac and vascular surgery. For the purpose of defining patient frailty a multimodal questionnaire has been developed including measurement of psychological, socioeconomical, neurological and behavioral aspects. This study also features an investigation of the possible relationship between sudden regional weather changes, individual meteorological susceptibility of the patients and the outcomes of adult cardiac and vascular surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing vascular procedures | – | –Including all non-interventional surgical procedures, excluding varix surgery |
| Patients undergoing cardiac procedures | – | –Including all non-interventional surgical procedures, excluding HTX |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive evaluable patients, 18 years old or older, admitted to Semmelweis University, Heart and Vascular Center for elective cardiac or vascular surgery.
Key inclusion criteria (1 listed)
- Patients, 18 years or older, admitted to the hospital for elective cardiac or vascular surgery.
Key exclusion criteria (8 listed)
- Not willing to participate.
- Pregnant women.
- During active psychiatric hospital care.
- Patients with defined legal incapability or limited capability.
- Congenital or acquired speech impediment and locomotion disability of any kind.
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
Length of hospital and intensive care unit stay.
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
8 secondary outcomes
The composite of in-hospital death from any cause.
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
Evidence of clinically definite postoperative acute kidney injury and the need for dialysis.
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
Evidence of clinically definite postoperative low cardiac output syndrome.
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
Evidence of clinically definite postoperative cardiac arrythmias.
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
Evidence of clinically definite postoperative SIRS.
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
Evidence of clinically definite postoperative acute lung injury and the need for mechanical ventilation.
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
Evidence of clinically definite postoperative peripheral vascular insufficiency.
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
The need for reoperation due to bleeding.
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2019.
- Derived from this study: PubMed 34670385Toth K, Szabo A, Nagy A, Szabo D, Szecsi B, Eke C, Sandor A, Susanszky E, Holndonner-Kirst E, Merkely B, Gal J, Szekely A. Preoperative nutritional state is associated with mid- and long-term mortality after cardiac surgery. Ann Palliat Med. 2021 Nov;10(11):11333-11347. doi: 10.21037/apm-21-1015. Epub 2021 Sep 29.
- Derived from this study: PubMed 33441102Szabo A, Toth K, Nagy A, Domokos D, Czobor N, Eke C, Sandor A, Merkely B, Susanszky E, Gal J, Szekely A. The effect of cognitive dysfunction on mid- and long-term mortality after vascular surgery. BMC Geriatr. 2021 Jan 13;21(1):46. doi: 10.1186/s12877-020-01994-x.
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.
Andrea Székely, MD, PhD study director
Semmelweis University, Department of Anesthesiology and Intensive Therapy
Daniel J Lex, MD principal investigator
Semmelweis University Heart and Vascular Center
Nikoletta Czobor principal investigator
Semmelweis University
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 Intellectual Frailty of Aging and Cardiovascular Diseases, run by Semmelweis University Heart and Vascular Center at 1 site in Hungary.
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 1 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 9 Apr 2019. 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 Hungary. 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?
Results are not available in the source record.
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?
Length of hospital and intensive care unit stay. (time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.). 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 NCT02224222, which also lists 2 linked publications.
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 9 Apr 2019.