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Completed

NCT Number: NCT05220111

Quality of Life 12 Months After Cardiac Surgery

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)

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Key information

Conditions

Quality of Life

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

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 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cardiac surgical operation (valve, aorta, coronary arteries)

Procedure

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

Other names: Quality of life assessment

Primary outcomes

  1. EQ-Visual Analogue Scale result, preoperative

    Time frame: preoperative

    EQ-Visual Analogue Scale, scale 0 (worst) to 100 (best possible), in percent

  2. 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

  3. 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

  4. Results of preoperative Quality of life dimensions

    Time frame: preoperative

    5 dimensions measurable with EQ5D-3L (scale 1,2 or 3) (ordinal scale)

  5. 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)

  6. 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)

Secondary outcomes

  1. Overall mortality rate

    Time frame: over the follow-up period ranging 3 to 9 years postoperatively

    Survival after surgery, annual postoperative, in percent

  2. Overall surgical morbidity rate

    Time frame: 0 to 12 months after surgery

    All surgical and cardiovascular complications, in percent

Other outcomes

  1. Re-hospitalization rate

    Time frame: over the follow-up period ranging 3 to 9 years postoperatively

    Re-admittance to health care facilities, annual postoperative, in percent

Sponsors and collaborators

Lead sponsor

Tampere University Hospital

Other

Collaborators

  • Tampere University

Registry information

Important dates

Study start
2013
Primary completion
2018
Study completion
2021
First posted
Feb 2, 2022
Registry last updated
Feb 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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