NCT04545437

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2020

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 10, 2020

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

September 3, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 11, 2020

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

April 20, 2023

Status Verified

April 1, 2023

Enrollment Period

3 years

First QC Date

September 3, 2020

Last Update Submit

April 19, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • Mortality

    5 years

  • Major adverse cardiovascular and vascular events

    5 years

  • Arrhythmia

    5 years

Secondary Outcomes (1)

  • Hospital re-admission

    5 years

Study Arms (1)

ICU

Patients treated on a general adult intensive care unit

Other: Admission to ICU

Interventions

Exposure is admission to an Intensive Care Unit

ICU

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Aged 16 years or above.
  • Admitted to an intensive care unit at a study site from 2006 onwards

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Royal Berkshire NHS Foundation Trust

Reading, Berkshire, RG1 5AN, United Kingdom

RECRUITING

Oxford University Hospitals

Oxford, Oxfordshire, OX3 9DU, United Kingdom

RECRUITING

Imperial College Healthcare NHS Trust

London, W12 0HS, United Kingdom

SUSPENDED

Related Links

MeSH Terms

Conditions

Critical IllnessMyocardial InfarctionStrokeAtrial FibrillationAtrial Flutter

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaNecrosisCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesArrhythmias, Cardiac

Study Officials

  • Peter Watkinson

    University of Oxford

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2020

First Posted

September 11, 2020

Study Start

August 10, 2020

Primary Completion

August 1, 2023

Study Completion

December 31, 2023

Last Updated

April 20, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

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.

Locations