Cardiovascular DiseasesNCT06330532
Impact of Preoperative Frailty and Cognitive Impairment on Postoperative Outcomes in Elderly Cardiac Surgery Patients
An observational study of Cardiovascular Diseases, run by Yonsei University at 1 site in South Korea.
Trial summary
This is a retrospective study of patients aged 65 years and older who underwent cardiac and aortic surgery between March 5, 2021 and October 12, 2022 in the operating room of Severance Cardiovascular Hospital to determine the impact of physical frailty as well as nutritional status, emotional dysregulation, and… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Cardiovascular Diseases
- How many people
- 447 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Mar 2024to 1 Oct 2024
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients age 65 and older undergoing heart and aortic surgery
Who may be able to join
- 65-year-old patients undergoing surgery for heart and aortic disease, who completed physical (Clinical Frailty scale, Handgrip strength), cognitive(K-MoCA, K-MMSE), and emotional (SGDS-K) functioning tests at the preoperative interview
Who cannot join
- Failed to complete two or more of assessments shown above
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Yonsei University Health system, Severance Hospital
Seoul, 03722
About this study
This is a retrospective study of patients aged 65 years and older who underwent cardiac and aortic surgery between March 5, 2021 and October 12, 2022 in the operating room of Severance Cardiovascular Hospital to determine the impact of physical frailty as well as nutritional status, emotional dysregulation, and cognitive dysfunction on postoperative outcomes. Physical frailty will be determined by the Clinical Frailty Scale, handgrip strength, and nutritional status, cognitive dysfunction will be determined by the K-MMSE and K-MoCA administered at the preoperative interview, and emotional dysregulation will be determined using the SGDS-K. These were measured during the pre-anesthesia evaluation and only results from patients who agreed to be tested will be used. Nutritional status will be analyzed based on blood test values measured within one month of surgery.
- Conditions
- Cardiovascular Diseases
- 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 categorized as having no frailty on the frailty item, assessed by four domains | cognitive, emotional, physical, and nutritional. | |
| Patients exhibiting the early signs that may lead to frailty, assessed in four domains | cognitive, emotional, physical, and nutritional. | |
| Patients categorized as having frailty on the frailty item, assessed by four domains | cognitive, emotional, physical, and nutritional. |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative all cause mortality
This study evaluates all-cause mortality within 1 year after surgery
Measured: within 1 year
major composite morbidity
Measured: within 30days after surgery for major composite morbidity
Secondary outcomes (2)
the number of days not in hospital
DAOH is the number of days not in hospital over a defined postoperative period
Measured: 90 days
The number of participants who die
patients who die
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start1 Mar 2024
- Primary completion5 Apr 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 447 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06330532
- Sponsor's protocol ID
- 4-2023-1526
- Status last verified
- Jan 2025
- First submitted
- 19 Mar 2024
- Last updated
- 10 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Preoperative Frailty and Cognitive Impairment on Postoperative Outcomes in Elderly Cardiac Surgery Patients
- ClinicalTrials.gov ID
- NCT06330532
- Acronym / sponsor ID
- 4-2023-1526
- Conditions
- Cardiovascular Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 447 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 5 Apr 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 26 Mar 2024 (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.
This is a retrospective study of patients aged 65 years and older who underwent cardiac and aortic surgery between March 5, 2021 and October 12, 2022 in the operating room of Severance Cardiovascular Hospital to determine the impact of physical frailty as well as nutritional status, emotional dysregulation, and cognitive dysfunction on postoperative outcomes. Physical frailty will be determined by the Clinical Frailty Scale, handgrip strength, and nutritional status, cognitive dysfunction will be determined by the K-MMSE and K-MoCA administered at the preoperative interview, and emotional dysregulation will be determined using the SGDS-K. These were measured during the pre-anesthesia evaluation and only results from patients who agreed to be tested will be used. Nutritional status will be analyzed based on blood test values measured within one month of surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients categorized as having no frailty on the frailty item, assessed by four domains | – | –cognitive, emotional, physical, and nutritional. |
| Patients exhibiting the early signs that may lead to frailty, assessed in four domains | – | –cognitive, emotional, physical, and nutritional. |
| Patients categorized as having frailty on the frailty item, assessed by four domains | – | –cognitive, emotional, physical, and nutritional. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients age 65 and older undergoing heart and aortic surgery
Key inclusion criteria (1 listed)
- 65-year-old patients undergoing surgery for heart and aortic disease, who completed physical (Clinical Frailty scale, Handgrip strength), cognitive(K-MoCA, K-MMSE), and emotional (SGDS-K) functioning tests at the preoperative interview
Key exclusion criteria (1 listed)
- Failed to complete two or more of assessments shown above
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
postoperative all cause mortality
Time frame: within 1 year
This study evaluates all-cause mortality within 1 year after surgery
major composite morbidity
Time frame: within 30days after surgery for major composite morbidity
2 secondary outcomes
the number of days not in hospital
Time frame: 90 days
The number of participants who die
Time frame: 30 days after surgery
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 10 Jan 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, run by Yonsei University at 1 site in South Korea.
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 1 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 10 Jan 2025. 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 South Korea. 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?
postoperative all cause mortality (time frame: within 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jan 2025.