The Short and Long-term Cardiovascular Consequences of Critical Illness: The C3 Study

Stroke Clinical Trial

— C3  

Official title:

The Short and Long-term Cardiovascular Consequences of Critical Illness: The C3 Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04545437
• Other study ID #: PID14762
• Secondary ID: Oxford Rec CConf
• Status: Recruiting
• Start date: August 10, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2023
• Source: University of Oxford
• Contact: Robert Hatch
• Phone: +44 (0) 1865 231456
• Email: robert.hatch[@]ndcn.ox.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80000
• Est. completion date: December 31, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Aged 16 years or above.

• Admitted to an intensive care unit at a study site from 2006 onwards

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Flutter
• Atrium; Fibrillation
• Critical Illness
• Infarction
• Myocardial Infarction
• Stroke

Intervention

Other:
• Admission to ICU
Exposure is admission to an Intensive Care Unit

Locations

Country	Name	City	State
United Kingdom	Imperial College Healthcare NHS Trust	London
United Kingdom	Oxford University Hospitals	Oxford	Oxfordshire
United Kingdom	Royal Berkshire NHS Foundation Trust	Reading	Berkshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Oxford

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality		5 years
Primary	Major adverse cardiovascular and vascular events		5 years
Primary	Arrhythmia		5 years
Secondary	Hospital re-admission		5 years

External Links

•   Critical Care Research Group main website
•   Study website