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

Recruiting

• Conditions: Critical Illness; Stroke; Atrium; Fibrillation; Atrial Flutter; Myocardial Infarction
• Interventions: Other: Admission to ICU

• Registration Number: NCT04545437
• Lead Sponsor: University of Oxford

Brief 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.

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 Timeline

• Study Start: 2020-08-10
• Study First Submitted: 2020-09-03
• Study First Submitted QC: 2020-09-03
• Study First Posted: 2020-09-11
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-19
• Last Update Posted: 2023-04-20
• Primary Completion: 2023-08-01
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ICU	Admission to ICU	Patients treated on a general adult intensive care unit

Primary Outcome Measures

Name	Time	Method
Mortality	5 years
Major adverse cardiovascular and vascular events	5 years
Arrhythmia	5 years

Secondary Outcome Measures

Name	Time	Method
Hospital re-admission	5 years

Trial Locations

Locations (3)

Oxford University Hospitals; 🇬🇧 Oxford, Oxfordshire, United Kingdom

Royal Berkshire NHS Foundation Trust; 🇬🇧 Reading, Berkshire, United Kingdom

Imperial College Healthcare NHS Trust; 🇬🇧 London, United Kingdom