Ignite Creation Date:
2025-12-24 @ 12:56 PM
Ignite Modification Date:
2026-02-12 @ 5:38 PM
Study NCT ID:
NCT04231461
Status:
COMPLETED
Last Update Posted:
2024-12-03
First Post:
2019-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quality of Life After Cardiac Surgery
Sponsor:
Papworth Hospital NHS Foundation Trust
Organization:
Study Overview
Official Title:
Quality of Life After Cardiac Surgery
Status:
COMPLETED
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
QUACS
Brief Summary:
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.
Detailed Description:
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:
1. How does having heart surgery affect the QoL immediately after the operation?
2. How long does it take patients to return to the same quality of life they had before the surgery?
3. How long does it take patients to regain any loss of quality of life due to the operation? Does quality of life improve thereafter?
4. What proportion of patients will achieve a net benefit in QoL?
5. 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.
1. How does having heart surgery affect the QoL immediately after the operation?
2. How long does it take patients to return to the same quality of life they had before the surgery?
3. How long does it take patients to regain any loss of quality of life due to the operation? Does quality of life improve thereafter?
4. What proportion of patients will achieve a net benefit in QoL?
5. 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: