Quality of Life 12 Months After Cardiac Surgery

Quality of Life Clinical Trial

Official title:

Quality of Life 12 Months After Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05220111
• Other study ID #: R12265
• Status: Completed
• Start date: April 1, 2013
• Est. completion date: December 31, 2021

Study information

• Verified date: January 2022
• Source: Tampere University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1594
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Quality of Life

Intervention

Procedure:
• Cardiac surgical operation (valve, aorta, coronary arteries)
Quality of life assessment using EQ-5D-3L

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Tampere University Hospital	Tampere University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Re-hospitalization rate	Re-admittance to health care facilities, annual postoperative, in percent	over the follow-up period ranging 3 to 9 years postoperatively
Primary	EQ-Visual Analogue Scale result, preoperative	EQ-Visual Analogue Scale, scale 0 (worst) to 100 (best possible), in percent	preoperative
Primary	EQ-Visual Analogue Scale result, at 6 months	EQ-Visual Analogue Scale, scale 0 (worst) to 100 (best possible), in percent	6 months after surgery
Primary	EQ-Visual Analogue Scale result, at 12 months	EQ-Visual Analogue Scale, scale 0 (worst) to 100 (best possible), in percent	12 months after surgery
Primary	Results of preoperative Quality of life dimensions	5 dimensions measurable with EQ5D-3L (scale 1,2 or 3) (ordinal scale)	preoperative
Primary	Results of Quality of life dimensions at 6 months after surgery	5 dimensions measurable with EQ5D-3L (scale 1,2 or 3)(ordinal scale)	6 months after surgery
Primary	Results of Quality of life dimensions at 12 months after surgery	5 dimensions measurable with EQ5D-3L (scale 1,2 or 3)(ordinal scale)	12 months after surgery
Secondary	Overall mortality rate	Survival after surgery, annual postoperative, in percent	over the follow-up period ranging 3 to 9 years postoperatively
Secondary	Overall surgical morbidity rate	All surgical and cardiovascular complications, in percent	0 to 12 months after surgery