Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-27 @ 10:19 AM
Study NCT ID:
NCT04366167
Status:
COMPLETED
Last Update Posted:
2022-10-13
First Post:
2020-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient Recovery From Heart Surgery During the Covid-19 Pandemic
Sponsor:
Barts & The London NHS Trust
Organization:
Study Overview
Official Title:
An Observational Cohort Study to Explore Patient Outcome From Heart Surgery During the Covid-19 Pandemic (CardiacCovid)
Status:
COMPLETED
Status Verified Date:
2021-10
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:
CardiacCovid
Brief Summary:
This study will describe and explore the recovery process of patients undergoing cardiac surgery during the covid-19 pandemic. This will include mortality, morbidity, health-related quality of life, event-specific distress and depression.
Detailed Description:
The overall aim of this study is to describe and explore the recovery process of patients undergoing cardiac surgery during the covid-19 pandemic. This will include mortality, morbidity, health-related quality of life, event-specific distress and depression.
All adult patients having cardiac surgery during the pandemic at St Bartholomew's Hospital will be approached to join this study. As of the end of March this is this is approximately 20 operations a week. Questionnaires will be administered at five time points alongside a review of clinical notes.
Appropriate descriptive and summative statistics will be used to analyse outcomes. If sample size is adequate, possible associations/effect of the impact of the covid-19 pandemic on each of the recovery parameters included in the study will be determined. The differences in outcomes between those with and without covid-19 may also be analysed if the sample size is adequate. Bias and loss to follow-up in observational cohort studies has been considered.
All adult patients having cardiac surgery during the pandemic at St Bartholomew's Hospital will be approached to join this study. As of the end of March this is this is approximately 20 operations a week. Questionnaires will be administered at five time points alongside a review of clinical notes.
Appropriate descriptive and summative statistics will be used to analyse outcomes. If sample size is adequate, possible associations/effect of the impact of the covid-19 pandemic on each of the recovery parameters included in the study will be determined. The differences in outcomes between those with and without covid-19 may also be analysed if the sample size is adequate. Bias and loss to follow-up in observational cohort studies has been considered.
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?:
None
Is an FDA AA801 Violation?: