Cardiac SurgeryCardiacCovidNCT04366167
Patient Recovery From Heart Surgery During the Covid-19 Pandemic
An observational study of Cardiac Surgery and COVID, run by Barts & The London NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Cardiac Surgery, COVID
- What is being tested?
- Cardiac surgery
- How many people
- 253 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Apr 2020to 3 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing cardiac surgery during the COVID-19 pandemic
Who may be able to join
- Undergoing cardiac surgery during the Covid-19 pandemic (end date as yet unknown but inferred when elective surgery is reinstated)
- Discharge from hospital where operation was performed is being planned
- Able and willing to give informed consent
Who cannot join
- Unable or unwilling to give written informed consent. This includes patients who are being transferred to another hospital and are considered too vulnerable or unwell to be approached (based on clinical judgement of the clinical care team)
- Unable or unwilling to give and/or complete the questionnaires
- Inability to understand written and/or verbal English
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Observational Cohort Study to Explore Patient Outcome From Heart Surgery During the Covid-19 Pandemic (CardiacCovid)
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.
Read the 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.
- Conditions
- Cardiac Surgery, COVID
- Being tested
- Cardiac surgery
- Keywords
- cardiac surgery, patient reported outcomes, COVID
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac surgeryOther
Cardiac surgery during the COVID-19 pandemic
| Study group | Role | What they receive |
|---|---|---|
| Cardiac surgery patients - lockdown 1 | Cohort 1 (lockdown 1): Patients undergoing adult cardiac surgery during the Covid-19 pandemic Receives: Other: Cardiac surgery | |
| Cardiac surgery patients - lockdown 2 | Cohort 2 (lockdown 2): Patients undergoing adult cardiac surgery during the Covid-19 pandemic Receives: Other: Cardiac surgery | |
| Cardiac surgery patients - lockdown 3 | Cohort 3 (lockdown 3): Patients undergoing adult cardiac surgery during the Covid-19 pandemic Receives: Other: Cardiac surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Impact of Events scores
The revised Impact of Events revised version (IES-R) questionnaire (Weiss and Marmar, 1997) is widely used as a measure of event-specific distress and measures distress experienced by serious life changes/events. It has been commonly used to assess persons with posttraumatic stress disorder (PTSD). It is an 22 item self-report scale where is item is reported on a five point likert scale from 0 (not at all) to 4 (extremely) with respect to how distressing each item has been during the past week. Scale scores are formed for the three subscales, which reflect intrusion (8 items: 1, 2, 3, 6, 9, 14, 16, 20), avoidance (8 items: 5,7,8,11,12,13,17,22), and hyperarousal (6 items: 4,10,15.18.19.21). A cut-off of 26 and above has been suggested for a clinically significant reaction to a psychological trauma, although the IES alone does not diagnose PTSD or reflect a person's ability to function. Metric for summarising data: t-test
Measured: Baseline, 1 week after discharge, 6 weeks (+/- 2 weeks) post surgery, 6 months (+/- 2 weeks) post surgery, 1 year (+/- 2 weeks) post surgery
Secondary outcomes (4)
Survival
Death or survival after cardiac surgery
Measured: Up to 1 year post surgery
Morbidity
patient completion of a log sheet documenting all 'visits' (including calls to NHS 111, face-to-face or virtual visits) to the emergency department, hospital admissions and visits to the general practitioner on a standardised proforma for the duration of the study
Measured: Up to 1 year post surgery
Change in Health-related quality of life scores
Health-related quality of life will be measured using the EQ5D-5L questionnaire. The EQ5D is a standardised, simple generic measure of health well, which is received by patients (Kim et al., 2005). It consists of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each with five levels of health response and a visual analogue scale (VAS) ranging from 0-100 (0 being the worst possible health imaginable and 100 being the best possible health imaginable). Metric for summarising data: t-test
Measured: Baseline, 1 week after discharge, 6 weeks (+/- 2 weeks) post surgery, 6 months (+/- 2 weeks) post surgery, 1 year (+/- 2 weeks) post surgery
Change in Depression scores
Depression will be measured using the Centre for Epidemiologic Studies Depression Scale (CES-D). The CES-D is a 20-item self-report adult instrument designed to measure common symptoms of depression that have occurred over the past week, such as poor appetite, hopelessness, pessimism, and fatigue. All questions are answered on a scale of 0-3, with 0 indicating no symptom presence and with 3 representing symptoms "most or all of the time." CES-D scores range from 0 to 60 with higher scores indicating more severe depressive symptoms. A score of 16 or higher identifies subjects with clinically meaningful depression. Metric for summarising data: t-test
Measured: Baseline, 1 week after discharge, 6 weeks (+/- 2 weeks) post surgery, 6 months (+/- 2 weeks) post surgery, 1 year (+/- 2 weeks) post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start18 Apr 2020
- Primary completion3 Mar 2022
- Study completion3 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 253 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barts & The London NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Queen Mary University of London
- Responsible party
- Sponsor
- Investigators
- Julie Sanders, PhD, Principal investigator, St. Bartholomew's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04366167
- Sponsor's protocol ID
- 132127
- Acronym
- CardiacCovid
- Status last verified
- Oct 2021
- First submitted
- 24 Apr 2020
- Last updated
- 13 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sanders J, Beaumont E, Dodd M, Murray SE, Owens G, Berry A, Hyde E, Bueser T, Clayton T, Oo AY. The impact of the COVID-19 pandemic on recovery from cardiac surgery over time: results of the CardiacCovid study from three UK national lockdowns. Eur J Cardiovasc Nurs. 2024 May 28;23(4):418-422. doi: 10.1093/eurjcn/zvad084.
PubMed 37585652Sanders J, Bueser T, Beaumont E, Dodd M, Murray SE, Owens G, Berry A, Hyde E, Clayton T, Oo AY. The impact of the COVID-19 pandemic on recovery from cardiac surgery: 1-year outcomes. Eur J Cardiovasc Nurs. 2023 Jul 19;22(5):516-528. doi: 10.1093/eurjcn/zvac083.
PubMed 36099505
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Cohort Study to Explore Patient Outcome From Heart Surgery During the Covid-19 Pandemic (CardiacCovid)
- ClinicalTrials.gov ID
- NCT04366167
- Acronym / sponsor ID
- CardiacCovid / 132127
- Conditions
- Cardiac Surgery, COVID
- Keywords
- cardiac surgery, patient reported outcomes, COVID
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 253 participants (actual)
- Lead sponsor
- Barts & The London NHS TrustUniversity, hospital or other
- Collaborators
- Queen Mary University of London
- Study start
- 18 Apr 2020 (actual)
- Primary completion
- 3 Mar 2022 (actual)
- Study completion
- 3 Mar 2022 (actual)
- First posted
- 28 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cardiac surgery patients - lockdown 1 | – | Other: Cardiac surgeryCohort 1 (lockdown 1): Patients undergoing adult cardiac surgery during the Covid-19 pandemic |
| Cardiac surgery patients - lockdown 2 | – | Other: Cardiac surgeryCohort 2 (lockdown 2): Patients undergoing adult cardiac surgery during the Covid-19 pandemic |
| Cardiac surgery patients - lockdown 3 | – | Other: Cardiac surgeryCohort 3 (lockdown 3): Patients undergoing adult cardiac surgery during the Covid-19 pandemic |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing cardiac surgery during the COVID-19 pandemic
Key inclusion criteria (3 listed)
- Undergoing cardiac surgery during the Covid-19 pandemic (end date as yet unknown but inferred when elective surgery is reinstated)
- Discharge from hospital where operation was performed is being planned
- Able and willing to give informed consent
Key exclusion criteria (3 listed)
- Unable or unwilling to give written informed consent. This includes patients who are being transferred to another hospital and are considered too vulnerable or unwell to be approached (based on clinical judgement of the clinical care team)
- Unable or unwilling to give and/or complete the questionnaires
- Inability to understand written and/or verbal English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac surgeryCardiac surgery during the COVID-19 pandemic | Other | Cardiac surgery patients - lockdown 1, Cardiac surgery patients - lockdown 2, Cardiac surgery patients - lockdown 3 |
Primary outcome
Change in Impact of Events scores
Time frame: Baseline, 1 week after discharge, 6 weeks (+/- 2 weeks) post surgery, 6 months (+/- 2 weeks) post surgery, 1 year (+/- 2 weeks) post surgery
The revised Impact of Events revised version (IES-R) questionnaire (Weiss and Marmar, 1997) is widely used as a measure of event-specific distress and measures distress experienced by serious life changes/events. It has been commonly used to assess persons with posttraumatic stress disorder (PTSD). It is an 22 item self-report scale where is item is reported on a five point likert scale from 0 (not at all) to 4 (extremely) with respect to how distressing each item has been during the past week. Scale scores are formed for the three subscales, which reflect intrusion (8 items: 1, 2, 3, 6, 9, 14, 16, 20), avoidance (8 items: 5,7,8,11,12,13,17,22), and hyperarousal (6 items: 4,10,15.18.19.21). A cut-off of 26 and above has been suggested for a clinically significant reaction to a psychological trauma, although the IES alone does not diagnose PTSD or reflect a person's ability to function. Metric for summarising data: t-test
4 secondary outcomes
Survival
Time frame: Up to 1 year post surgery
Morbidity
Time frame: Up to 1 year post surgery
Change in Health-related quality of life scores
Time frame: Baseline, 1 week after discharge, 6 weeks (+/- 2 weeks) post surgery, 6 months (+/- 2 weeks) post surgery, 1 year (+/- 2 weeks) post surgery
Change in Depression scores
Time frame: Baseline, 1 week after discharge, 6 weeks (+/- 2 weeks) post surgery, 6 months (+/- 2 weeks) post surgery, 1 year (+/- 2 weeks) post surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
- Derived from this study: PubMed 37585652Sanders J, Beaumont E, Dodd M, Murray SE, Owens G, Berry A, Hyde E, Bueser T, Clayton T, Oo AY. The impact of the COVID-19 pandemic on recovery from cardiac surgery over time: results of the CardiacCovid study from three UK national lockdowns. Eur J Cardiovasc Nurs. 2024 May 28;23(4):418-422. doi: 10.1093/eurjcn/zvad084.
- Derived from this study: PubMed 36099505Sanders J, Bueser T, Beaumont E, Dodd M, Murray SE, Owens G, Berry A, Hyde E, Clayton T, Oo AY. The impact of the COVID-19 pandemic on recovery from cardiac surgery: 1-year outcomes. Eur J Cardiovasc Nurs. 2023 Jul 19;22(5):516-528. doi: 10.1093/eurjcn/zvac083.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie Sanders, PhD principal investigator
St. Bartholomew's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Surgery and COVID, run by Barts & The London NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Impact of Events scores (time frame: Baseline, 1 week after discharge, 6 weeks (+/- 2 weeks) post surgery, 6 months (+/- 2 weeks) post surgery, 1 year (+/- 2 weeks) post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04366167, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2022; AzTrials last refreshed its copy on 8 Nov 2026.