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Quality of Life 12 Months After Cardiac Surgery

Quality of Life 12 Months After Cardiac Surgery

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05220111
Enrollment
1594
Registered
2022-02-02
Start date
2013-04-01
Completion date
2021-12-31
Last updated
2022-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Quality of Life

Keywords

Quality of Life, postoperative

Brief 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)

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.

Interventions

PROCEDURECardiac surgical operation (valve, aorta, coronary arteries)

Quality of life assessment using EQ-5D-3L

Sponsors

Tampere University
CollaboratorOTHER
Tampere University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Results of Quality of life dimensions at 12 months after surgery12 months after surgery5 dimensions measurable with EQ5D-3L (scale 1,2 or 3)(ordinal scale)
EQ-Visual Analogue Scale result, at 12 months12 months after surgeryEQ-Visual Analogue Scale, scale 0 (worst) to 100 (best possible), in percent
Results of preoperative Quality of life dimensionspreoperative5 dimensions measurable with EQ5D-3L (scale 1,2 or 3) (ordinal scale)
Results of Quality of life dimensions at 6 months after surgery6 months after surgery5 dimensions measurable with EQ5D-3L (scale 1,2 or 3)(ordinal scale)
EQ-Visual Analogue Scale result, preoperativepreoperativeEQ-Visual Analogue Scale, scale 0 (worst) to 100 (best possible), in percent
EQ-Visual Analogue Scale result, at 6 months6 months after surgeryEQ-Visual Analogue Scale, scale 0 (worst) to 100 (best possible), in percent

Secondary

MeasureTime frameDescription
Overall mortality rateover the follow-up period ranging 3 to 9 years postoperativelySurvival after surgery, annual postoperative, in percent
Overall surgical morbidity rate0 to 12 months after surgeryAll surgical and cardiovascular complications, in percent

Other

MeasureTime frameDescription
Re-hospitalization rateover the follow-up period ranging 3 to 9 years postoperativelyRe-admittance to health care facilities, annual postoperative, in percent

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026