Skip to main content
OpenTrials
Completed

NCT Number: NCT04231461

Quality of Life After Cardiac Surgery

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Aortic Valve Stenosis Aorta Disease Aortic Diseases Aortic Valve Disease Cardiovascular Diseases Coronary Artery Bypass Graft Heart Diseases Heart Valve Diseases Mitral Valve Disease Tricuspid Valve Disease Vascular Diseases Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal Papworth Hospital

Cambridge, Cambridgeshire, CB2 0AY, United Kingdom

About this study

The Sponsor shall use existing questionnaires to measure QoL in patients having major heart surgery. QoL will be measured before the operation and monthly afterwards for 12 months in order to answer the following questions:

  • How does having heart surgery affect the QoL immediately after the operation?
  • How long does it take patients to return to the same quality of life they had before the surgery?
  • How long does it take patients to regain any loss of quality of life due to the operation? Does quality of life improve thereafter?
  • What proportion of patients will achieve a net benefit in QoL?
  • Are there features that can predict who will benefit in terms of QoL and who will not? The Sponsor will use the data to develop an electronic calculator to enable quick and robust evaluation of the impact of heart surgery on the QoL of individuals. Patients will then be able to give truly informed consent and to decide if they wish have surgery based on a full knowledge of both surgical risk and the potential impact on QoL.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

cardiac surgery

Procedure

Routine or urgent cardiac surgery

Other names: Aortic Valve Procedure, Mitral Valve Procedure, Tricuspid Valve Procedure, Procedure on Aorta, Other major cardiac intervention, Other minimal access incisions

Primary outcomes

  1. Change in Quality of Life using Questionnaire EQ-5D

    Time frame: 12 Months

    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.

Secondary outcomes

  1. Change in Quality of Life using Questionnaire SF-12

    Time frame: 12 Months

    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.

Other outcomes

  1. Change in Quality of Life using Questionnaire LOT

    Time frame: 12 months

    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.

  2. Change in Quality of Life using Questionnaire PANAS

    Time frame: 12 months

    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.

Sponsors and collaborators

Lead sponsor

Papworth Hospital NHS Foundation Trust

Other Gov

Registry information

Acronym: QUACS

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Jan 18, 2020
Registry last updated
Dec 3, 2024

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.