DeliriumNCT02356523
Incidence and Prognostic Value of Delirium in Patients With Acute Coronary Syndromes
An observational study of Delirium, run by Ospedale San Donato at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Delirium
- What is being tested?
- Confusion Assessment Method
- How many people
- 700 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2014to Oct 2015
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients admitted in Cardiac Intensive Care Unit for any condition
Who may be able to join
- Admission in Cardiac Intensive Care Unit
- Age ≥ 65 years
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Delirium
- Being tested
- Confusion Assessment Method
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Confusion Assessment MethodDiagnostic test
Administration of Confusion Assessment Method at patent over 65 years at admission and every day until discharge
| Study group | Role | What they receive |
|---|---|---|
| Delirium patients | Patients positive to Confusion Assessment Method (CAM) assessment ad admission and during hospital stay Receives: Diagnostic Test: Confusion Assessment Method | |
| control group | Patients negative to Confusion Assessment Method (CAM) assessment ad admission and during hospital stay Receives: Diagnostic Test: Confusion Assessment Method |
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnosis of delirium by confusion assessment method
incidence of delirium in elderly patients with coronary acute syndromes
Measured: within 24 hours of admission
Secondary outcomes (1)
adverse events incidence
any adverse event occurred to patients during hospital stay not due to the illness
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2015 (estimated)
- Study startJan 2014
- Primary completionMar 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 700 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Ospedale San Donato
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leonardo Bolognese, MD, Ospedale San Donato
- Investigators
- Leonardo Bolognese, MD, FESC, Study chair, Cardiovascular Department San Donato Hospital Arezzo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02356523
- Sponsor's protocol ID
- Arezzo014
- Status last verified
- Mar 2023
- First submitted
- 2 Feb 2015
- Last updated
- 15 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: recording in excel files
Publications
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.
PubMed 9894730Hsieh 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.
PubMed 24364769McPherson 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.
PubMed 23263581
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Prognostic Value of Delirium in Elderly Patients With Acute Coronary Syndrome Admitted to Two Cardiac Intensive Care Units: a Prospective Study
- ClinicalTrials.gov ID
- NCT02356523
- Acronym / sponsor ID
- Arezzo014
- Conditions
- Delirium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- Ospedale San DonatoUniversity, hospital or other
- Study start
- Jan 2014 (actual)
- Primary completion
- Mar 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 5 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Delirium patients | – | Diagnostic Test: Confusion Assessment MethodPatients positive to Confusion Assessment Method (CAM) assessment ad admission and during hospital stay |
| control group | – | Diagnostic Test: Confusion Assessment MethodPatients negative to Confusion Assessment Method (CAM) assessment ad admission and during hospital stay |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients admitted in Cardiac Intensive Care Unit for any condition
Key inclusion criteria (2 listed)
- Admission in Cardiac Intensive Care Unit
- Age ≥ 65 years
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Confusion Assessment MethodAdministration of Confusion Assessment Method at patent over 65 years at admission and every day until discharge | Diagnostic test | Delirium patients, control group |
Primary outcome
diagnosis of delirium by confusion assessment method
Time frame: within 24 hours of admission
incidence of delirium in elderly patients with coronary acute syndromes
1 secondary outcome
adverse events incidence
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
- Background: PubMed 9894730Inouye 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.
- Background: PubMed 24364769Hsieh 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.
- Background: PubMed 23263581McPherson 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.
- Individual participant dataSharing planned: Undecided. recording in excel files
Related trials for Delirium
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The Danish Out-of-Hospital Cardiac Arrest Study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leonardo Bolognese, MD, FESC study chair
Cardiovascular Department San Donato Hospital Arezzo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium, run by Ospedale San Donato at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diagnosis of delirium by confusion assessment method (time frame: within 24 hours of admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02356523, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2023.