Critical IllnessC3NCT04545437
The Short and Long-term Cardiovascular Consequences of Critical Illness: The C3 Study
An observational study of Critical Illness and Myocardial Infarction, run by University of Oxford at 3 sites in United Kingdom.
Trial summary
The aim this study will be to find out which patients are at risk of heart attacks/strokes up to several years after discharge from an ICU. This study will also investigate whether treatments and events occurring in ICU contribute to this risk. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Critical Illness, Myocardial Infarction, Stroke
- What is being tested?
- Admission to ICU
- How many people
- 80,000 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 10 Aug 2020to 31 Dec 2023
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adult patients admitted to a general adult intensive care unit at one or more of the study sites between 2006 and 1st of August 2023.
Who may be able to join
- Aged 16 years or above.
- Admitted to an intensive care unit at a study site from 2006 onwards
Who cannot join
- Patients that have informed their participating site that they do not wish their electronic records would be used for future research
- Patients who inform us directly that they don't wish their records used in this research study
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites, 2 recruiting
- Suspended
Imperial College Healthcare NHS Trust
London, W12 0HS
- Recruiting
Oxford University Hospitals
Oxford, Oxfordshire, OX3 9DU
Peter Watkinson, peter.watkinson@ndcn.ox.ac.uk
Peter Watkinson
- Recruiting
Royal Berkshire NHS Foundation Trust
Reading, Berkshire, RG1 5AN
Ian Rechner
Ian Rechner
About this study
The aim this study will be to find out which patients are at risk of heart attacks/strokes up to several years after discharge from an ICU. This study will also investigate whether treatments and events occurring in ICU contribute to this risk.
Read the detailed description
Undertake a retrospective observational cohort study of patients admitted to intensive care units between 2006 and 2023.
Study Participants: Adult patients admitted to a general adult intensive care unit at one or more of the study sites between 2006 and 1st of August 2023.
Objectives:
To determine the short and long-term cardiovascular consequences of critical illness and identify in-ICU factors that affect them.
To identify the risk factors for new-onset atrial fibrillation/flutter occurring during critical illness.
To study the association between poor cardiovascular function during critical illness and long-term cardiovascular disease.
This study will provide new knowledge about the associations between baseline cardiovascular risk, the disease resulting in ICU admission and therapies / events on ICU with subsequent major adverse cardiac events (MACE), to allow the ongoing risk of these events to be determined. If clinicans can idetnify who is at risk, then risk factors can potentially be modified .
- Being tested
- Admission to ICU
- Medical subject headings
- Critical Illness, Myocardial Infarction, Stroke, Atrial Fibrillation, Atrial Flutter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Admission to ICUOther
Exposure is admission to an Intensive Care Unit
| Study group | Role | What they receive |
|---|---|---|
| ICU | Patients treated on a general adult intensive care unit Receives: Other: Admission to ICU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: 5 years
Major adverse cardiovascular and vascular events
Measured: 5 years
Arrhythmia
Measured: 5 years
Secondary outcomes (1)
Hospital re-admission
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2020
- Study start10 Aug 2020
- Primary completion1 Aug 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 80,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Watkinson, Study director, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04545437
- Sponsor's protocol ID
- PID14762
- Other IDs
- Oxford Rec C, Confidentiality Advisory Group
- Acronym
- C3
- Status last verified
- Apr 2023
- First submitted
- 3 Sep 2020
- Last updated
- 20 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made publically available due to privacy and legal implications. Secondary analysis of the study will be considered on a case by case basis.
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Short and Long-term Cardiovascular Consequences of Critical Illness: The C3 Study
- ClinicalTrials.gov ID
- NCT04545437
- Acronym / sponsor ID
- C3 / PID14762
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80,000 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 10 Aug 2020 (actual)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 11 Sep 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.
The aim this study will be to find out which patients are at risk of heart attacks/strokes up to several years after discharge from an ICU. This study will also investigate whether treatments and events occurring in ICU contribute to this risk.
Detailed description
Undertake a retrospective observational cohort study of patients admitted to intensive care units between 2006 and 2023.
Study Participants: Adult patients admitted to a general adult intensive care unit at one or more of the study sites between 2006 and 1st of August 2023.
Objectives:
To determine the short and long-term cardiovascular consequences of critical illness and identify in-ICU factors that affect them.
To identify the risk factors for new-onset atrial fibrillation/flutter occurring during critical illness.
To study the association between poor cardiovascular function during critical illness and long-term cardiovascular disease.
This study will provide new knowledge about the associations between baseline cardiovascular risk, the disease resulting in ICU admission and therapies / events on ICU with subsequent major adverse cardiac events (MACE), to allow the ongoing risk of these events to be determined. If clinicans can idetnify who is at risk, then risk factors can potentially be modified .
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICU | – | Other: Admission to ICUPatients treated on a general adult intensive care unit |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult patients admitted to a general adult intensive care unit at one or more of the study sites between 2006 and 1st of August 2023.
Key inclusion criteria (2 listed)
- Aged 16 years or above.
- Admitted to an intensive care unit at a study site from 2006 onwards
Key exclusion criteria (2 listed)
- Patients that have informed their participating site that they do not wish their electronic records would be used for future research
- Patients who inform us directly that they don't wish their records used in this research study
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 |
|---|---|---|
| Admission to ICUExposure is admission to an Intensive Care Unit | Other | ICU |
Primary outcome
Mortality
Time frame: 5 years
Major adverse cardiovascular and vascular events
Time frame: 5 years
Arrhythmia
Time frame: 5 years
1 secondary outcome
Hospital re-admission
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2023.
- Critical Care Research Group main websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data will not be made publically available due to privacy and legal implications. Secondary analysis of the study will be considered on a case by case basis.
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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.
Peter Watkinson study director
University of Oxford
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness and Myocardial Infarction, run by University of Oxford at 3 sites 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 20 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robert Hatch (+44 (0) 1865 231456, robert.hatch@ndcn.ox.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Apr 2023.