Aortic Valve Stenosis Clinical Trial
— QUACSOfficial title:
Quality of Life After Cardiac Surgery
NCT number | NCT04231461 |
Other study ID # | P02500 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | July 19, 2019 |
Est. completion date | April 30, 2024 |
During the last twenty years heart surgery has become safer and the number of patients having heart surgery has increased with more frail patients being offered increasingly complex surgery. Heart operations often improve survival and quality of life (QoL), but that is not true for all patients. Regarding survival, clinicians can measure the risk to life from having a heart operation and the risk to life from not quite precisely, but clinicians have little idea about the impact of heart operations on QoL, which is the outcome that patients care about most. Clinicians are unable to provide patients with robust information on how an operation will affect their QoL. This study will provide this information by analysing the data from patient questionnaires immediately before and after the procedure and monthly thereafter for 12 months.
Status | Recruiting |
Enrollment | 8004 |
Est. completion date | April 30, 2024 |
Est. primary completion date | April 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - EuroSCORE II = 3% or EuroSCORE logistic of = 6% - Patients undergoing routine/ urgent cardiac surgery - Patients must have the ability to provide informed consent Exclusion Criteria: - Patients undergoing salvage or emergency operations |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Royal Papworth Hospital | Cambridge | Cambridgeshire |
Lead Sponsor | Collaborator |
---|---|
Papworth Hospital NHS Foundation Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in Quality of Life using Questionnaire LOT | Conduct questionnaire LOT to assess Quality of Life Change post major cardiac surgery procedure. These questionnaires ask patients to assess their levels of pain, mobility, anxiety and depression to give an overall Quality of Life Measure. | 12 months | |
Other | Change in Quality of Life using Questionnaire PANAS | Conduct questionnaire PANAS to assess Quality of Life Change post major cardiac surgery procedure. These questionnaires ask patients to assess their levels of pain, mobility, anxiety and depression to give an overall Quality of Life Measure. | 12 months | |
Primary | Change in Quality of Life using Questionnaire EQ-5D | Conduct questionnaire EQ-5D to assess Quality of Life Change post major cardiac surgery procedure. These questionnaires ask patients to assess their levels of pain, mobility, anxiety and depression to give an overall Quality of Life Measure. | 12 Months | |
Secondary | Change in Quality of Life using Questionnaire SF-12 | Conduct questionnaire SF-12 to assess Quality of Life Change post major cardiac surgery procedure. These questionnaires ask patients to assess their levels of pain, mobility, anxiety and depression to give an overall Quality of Life Measure. | 12 Months |
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