Incidence and Prognostic Value of DELIRIUM in Patients With Acute CORonary synDrome: an observatIonal Study

December 4, 2013 updated by: Leonardo Bolognese, MD, Ospedale San Donato

Incidence and Prognostic Value of DELIRIUM in Patients With Acute CORonary synDrome: an observatIonal Study by the DELIRIUM-CORDIS Investigators.

to evaluate the incidence of delirium in patients with acute coronary syndrome and its correlation with adverse events

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

400

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
        • Recruiting
        • Cardiovascular Department, Ospedale S.Donato
        • Principal Investigator:
          • Leonardo Bolognese, MD, FESC
        • Contact:
        • Principal Investigator:
          • Giovanni Falsini, MD

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

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients with acute coronary syndrome and delirium

Description

Inclusion Criteria:

  • acute coronary syndrome patients undergone coronary revascularization or referred to conservative strategy
  • age ≥ 70 years
  • diagnosis of delirium by the Confusion Assessment Method in the ICU (CAM-ICU) scale

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
acute coronary syndrome and delirium
patients with acute coronary syndrome and delirium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
in-hospital adverse events incidence
Time Frame: until discharge (4-7 days from admission)
until discharge (4-7 days from admission)

Secondary Outcome Measures

Outcome Measure
Time Frame
12-month adverse events incidence
Time Frame: 12 months
12 months

Collaborators and Investigators

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

Sponsor

Ospedale San Donato

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

December 1, 2013

Primary Completion (Anticipated)

November 1, 2015

Study Completion (Anticipated)

November 1, 2016

Study Registration Dates

First Submitted

November 24, 2013

First Submitted That Met QC Criteria

December 4, 2013

First Posted (Estimate)

December 9, 2013

Study Record Updates

Last Update Posted (Estimate)

December 9, 2013

Last Update Submitted That Met QC Criteria

December 4, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Arezzo012

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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