Quality of LifeNCT05220111
Quality of Life 12 Months After Cardiac Surgery
An observational study of Quality of Life, run by Tampere University Hospital.
Trial summary
Cardiac surgical patients entering the hospital for operation were voluntarily recruited to participate a 12 month follow- up of health related quality of life (QOL) Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Quality of Life
- What is being tested?
- Cardiac surgical operation (valve, aorta, coronary arteries)
- Type of treatment
- Surgery or procedure
- How many people
- 1,594 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2013to 31 Dec 2021
- How long will I take part?
- 3 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All comers for primary or secondary major cardiac surgery (cabg, valve, aorta or combined procedures)
Who may be able to join
- elective or urgent cardiac surgery (open heart procedure to valves or ascending aorta /arch, on-pump or off-pump surgery to the coronary arteries )
- willingness to participate,
- ability to comprehend Finnish language
Who cannot join
- emergency surgery (with no time to introduce the study in good time)
- not willing to participate,
- blind or other disturbance in seeing,
- inability to comprehend Finnish language
About this study
Cardiac surgical patients entering the hospital for operation were voluntarily recruited to participate a 12 month follow- up of health related quality of life (QOL)
Read the detailed description
Cardiac surgical patients entering the hospital for operation were voluntarily recruited to participate a 12 month follow- up of health related quality of life based on established QOL measurements with EuroQol quality of life 5 dimensional 3 level (EQ-5D-3L) description system at preoperative, 6 months and 12 months postoperatively. The study started on May 2013 and ended at the end of 2018. The data has been analyzed for publication in 2021. The total number of patients reached 1594.
- Conditions
- Quality of Life
- Being tested
- Cardiac surgical operation (valve, aorta, coronary arteries)
- Keywords
- Quality of Life, postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac surgical operation (valve, aorta, coronary arteries)Procedure or surgery
Also called Quality of life assessment
Quality of life assessment using EQ-5D-3L
What is being measured
The primary outcome is the main question the study is designed to answer.
EQ-Visual Analogue Scale result, preoperative
EQ-Visual Analogue Scale, scale 0 (worst) to 100 (best possible), in percent
Measured: preoperative
EQ-Visual Analogue Scale result, at 6 months
EQ-Visual Analogue Scale, scale 0 (worst) to 100 (best possible), in percent
Measured: 6 months after surgery
EQ-Visual Analogue Scale result, at 12 months
EQ-Visual Analogue Scale, scale 0 (worst) to 100 (best possible), in percent
Measured: 12 months after surgery
Results of preoperative Quality of life dimensions
5 dimensions measurable with EQ5D-3L (scale 1,2 or 3) (ordinal scale)
Measured: preoperative
Results of Quality of life dimensions at 6 months after surgery
5 dimensions measurable with EQ5D-3L (scale 1,2 or 3)(ordinal scale)
Measured: 6 months after surgery
Results of Quality of life dimensions at 12 months after surgery
5 dimensions measurable with EQ5D-3L (scale 1,2 or 3)(ordinal scale)
Measured: 12 months after surgery
Secondary outcomes (2)
Overall mortality rate
Survival after surgery, annual postoperative, in percent
Measured: over the follow-up period ranging 3 to 9 years postoperatively
Overall surgical morbidity rate
All surgical and cardiovascular complications, in percent
Measured: 0 to 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2022
- Study start1 Apr 2013
- Primary completion31 Dec 2018
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,594 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tampere University
- Responsible party
- Sponsor
- Investigators
- Jari Laurikka, MD,PhD, Study director, Head of Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05220111
- Sponsor's protocol ID
- R12265
- Status last verified
- Jan 2022
- First submitted
- 14 Jan 2022
- Last updated
- 2 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: local legislation prevents personal data sharing
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life 12 Months After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT05220111
- Acronym / sponsor ID
- R12265
- Conditions
- Quality of Life
- Keywords
- Quality of Life, postoperative
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,594 participants (actual)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Collaborators
- Tampere University
- Study start
- 1 Apr 2013 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 2 Feb 2022 (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.
Cardiac surgical patients entering the hospital for operation were voluntarily recruited to participate a 12 month follow- up of health related quality of life (QOL)
Detailed description
Cardiac surgical patients entering the hospital for operation were voluntarily recruited to participate a 12 month follow- up of health related quality of life based on established QOL measurements with EuroQol quality of life 5 dimensional 3 level (EQ-5D-3L) description system at preoperative, 6 months and 12 months postoperatively. The study started on May 2013 and ended at the end of 2018. The data has been analyzed for publication in 2021. The total number of patients reached 1594.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All comers for primary or secondary major cardiac surgery (cabg, valve, aorta or combined procedures)
Key inclusion criteria (3 listed)
- elective or urgent cardiac surgery (open heart procedure to valves or ascending aorta /arch, on-pump or off-pump surgery to the coronary arteries )
- willingness to participate,
- ability to comprehend Finnish language
Key exclusion criteria (4 listed)
- emergency surgery (with no time to introduce the study in good time)
- not willing to participate,
- blind or other disturbance in seeing,
- inability to comprehend Finnish language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac surgical operation (valve, aorta, coronary arteries)Also: Quality of life assessmentQuality of life assessment using EQ-5D-3L | Procedure or surgery | – |
Primary outcome
EQ-Visual Analogue Scale result, preoperative
Time frame: preoperative
EQ-Visual Analogue Scale, scale 0 (worst) to 100 (best possible), in percent
EQ-Visual Analogue Scale result, at 6 months
Time frame: 6 months after surgery
EQ-Visual Analogue Scale, scale 0 (worst) to 100 (best possible), in percent
EQ-Visual Analogue Scale result, at 12 months
Time frame: 12 months after surgery
EQ-Visual Analogue Scale, scale 0 (worst) to 100 (best possible), in percent
Results of preoperative Quality of life dimensions
Time frame: preoperative
5 dimensions measurable with EQ5D-3L (scale 1,2 or 3) (ordinal scale)
Results of Quality of life dimensions at 6 months after surgery
Time frame: 6 months after surgery
5 dimensions measurable with EQ5D-3L (scale 1,2 or 3)(ordinal scale)
Results of Quality of life dimensions at 12 months after surgery
Time frame: 12 months after surgery
5 dimensions measurable with EQ5D-3L (scale 1,2 or 3)(ordinal scale)
2 secondary outcomes
Overall mortality rate
Time frame: over the follow-up period ranging 3 to 9 years postoperatively
Overall surgical morbidity rate
Time frame: 0 to 12 months 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 2 Feb 2022.
- Individual participant dataSharing planned: No. local legislation prevents personal data sharing
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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.
Jari Laurikka, MD,PhD study director
Head of Department
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Life, run by Tampere University Hospital.
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 3 inclusion and 4 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 2 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
EQ-Visual Analogue Scale result, preoperative (time frame: preoperative). The study lists 6 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 2 Feb 2022.