Incidence and Prognostic Value of Delirium in Patients With Acute Coronary Syndromes

March 11, 2023 updated by: Leonardo Bolognese, MD, Ospedale San Donato

Long-term Prognostic Value of Delirium in Elderly Patients With Acute Coronary Syndrome Admitted to Two Cardiac Intensive Care Units: a Prospective Study

The Purpose of this study is to evaluate the incidence of delirium in patients with acute coronary syndromes admitted to a Intensive Care Unit Patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The present study is a prospective, two-centre registry aimed at assessing the incidence, prevalence and prognostic significance of delirium in elderly patients with acute coronary syndromes

Study Type

Observational

Enrollment (Actual)

700

Contacts and Locations

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

Study Locations

  • Italy
    • AR
      • Arezzo, AR, Italy, 52100
        • Cardiovascular Department, Ospedale S.Donato

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

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients admitted in Cardiac Intensive Care Unit for any condition

Description

Inclusion Criteria:

  • Admission in Cardiac Intensive Care Unit
  • Age ≥ 65 years

Exclusion Criteria:

  • none

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Delirium patients
Patients positive to Confusion Assessment Method (CAM) assessment ad admission and during hospital stay
Diagnostic test: Confusion Assessment Method
Administration of Confusion Assessment Method at patent over 65 years at admission and every day until discharge
control group
Patients negative to Confusion Assessment Method (CAM) assessment ad admission and during hospital stay
Diagnostic test: Confusion Assessment Method
Administration of Confusion Assessment Method at patent over 65 years at admission and every day until discharge

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
diagnosis of delirium by confusion assessment method
Time Frame: within 24 hours of admission
incidence of delirium in elderly patients with coronary acute syndromes
within 24 hours of admission

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
adverse events incidence
Time Frame: 6 months
any adverse event occurred to patients during hospital stay not due to the illness
6 months

Collaborators and Investigators

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

Sponsor

Ospedale San Donato

Investigators

  • Study Chair: Leonardo Bolognese, MD, FESC, Cardiovascular Department San Donato Hospital Arezzo

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.

General Publications

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)

January 1, 2014

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

February 2, 2015

First Submitted That Met QC Criteria

February 4, 2015

First Posted (Estimate)

February 5, 2015

Study Record Updates

Last Update Posted (Actual)

March 15, 2023

Last Update Submitted That Met QC Criteria

March 11, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Arezzo014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

recording in excel files

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.

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