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

April 19, 2023 updated by: University of Oxford
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

80000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
      • London, United Kingdom, W12 0HS
        • Suspended
        • Imperial College Healthcare NHS Trust
    • Berkshire
      • Reading, Berkshire, United Kingdom, RG1 5AN
        • Recruiting
        • Royal Berkshire NHS foundation trust
        • Contact:
          • Ian Rechner
        • Principal Investigator:
          • Ian Rechner
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 9DU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ICU
Patients treated on a general adult intensive care unit
Other: Admission to ICU
Exposure is admission to an Intensive Care Unit

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mortality
Time Frame: 5 years
5 years
Major adverse cardiovascular and vascular events
Time Frame: 5 years
5 years
Arrhythmia
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Hospital re-admission
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oxford

Investigators

  • Study Director: Peter Watkinson, University of Oxford

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 10, 2020

Primary Completion (Anticipated)

August 1, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

September 3, 2020

First Submitted That Met QC Criteria

September 3, 2020

First Posted (Actual)

September 11, 2020

Study Record Updates

Last Update Posted (Actual)

April 20, 2023

Last Update Submitted That Met QC Criteria

April 19, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PID14762
  • Oxford Rec C (Other Identifier: 20/SC/0105)
  • Confidentiality Advisory Group (Other Identifier: 20/CAG/0038)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Myocardial Infarction

Clinical Trials on Admission to ICU

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe