NCT02356523

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
700

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2014

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 2, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 5, 2015

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

March 15, 2023

Status Verified

March 1, 2023

Enrollment Period

1.2 years

First QC Date

February 2, 2015

Last Update Submit

March 11, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • diagnosis of delirium by confusion assessment method

    incidence of delirium in elderly patients with coronary acute syndromes

    within 24 hours of admission

Secondary Outcomes (1)

  • adverse events incidence

    6 months

Study Arms (2)

Delirium patients

Patients positive to Confusion Assessment Method (CAM) assessment ad admission and during hospital stay

Diagnostic Test: Confusion Assessment Method

control group

Patients negative to Confusion Assessment Method (CAM) assessment ad admission and during hospital stay

Diagnostic Test: Confusion Assessment Method

Interventions

Administration of Confusion Assessment Method at patent over 65 years at admission and every day until discharge

Delirium patientscontrol group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients admitted in Cardiac Intensive Care Unit for any condition

You may qualify if:

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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiovascular Department, Ospedale S.Donato

Arezzo, AR, 52100, Italy

Location

Related Publications (3)

  • Inouye SK. Delirium in hospitalized older patients: recognition and risk factors. J Geriatr Psychiatry Neurol. 1998 Fall;11(3):118-25; discussion 157-8. doi: 10.1177/089198879801100302.

    PMID: 9894730BACKGROUND
  • Hsieh SJ, Ely EW, Gong MN. Can intensive care unit delirium be prevented and reduced? Lessons learned and future directions. Ann Am Thorac Soc. 2013 Dec;10(6):648-56. doi: 10.1513/AnnalsATS.201307-232FR.

    PMID: 24364769BACKGROUND
  • McPherson JA, Wagner CE, Boehm LM, Hall JD, Johnson DC, Miller LR, Burns KM, Thompson JL, Shintani AK, Ely EW, Pandharipande PP. Delirium in the cardiovascular ICU: exploring modifiable risk factors. Crit Care Med. 2013 Feb;41(2):405-13. doi: 10.1097/CCM.0b013e31826ab49b.

    PMID: 23263581BACKGROUND

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental Disorders

Study Officials

  • Leonardo Bolognese, MD, FESC

    Cardiovascular Department San Donato Hospital Arezzo

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 2, 2015

First Posted

February 5, 2015

Study Start

January 1, 2014

Primary Completion

March 1, 2015

Study Completion

October 1, 2015

Last Updated

March 15, 2023

Record last verified: 2023-03

Locations