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NCT02004665 Clinical Trial

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

Acute Coronary Syndrome Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02004665
Other study ID # Arezzo012
Secondary ID
Status Recruiting
Phase N/A
First received November 24, 2013
Last updated December 4, 2013
Start date December 2013
Est. completion date November 2016

Study information
Verified date December 2013
Source Ospedale San Donato
Contact n/a
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Observational [Patient Registry]

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 400
Est. completion date November 2016
Est. primary completion date November 2015
Accepts healthy volunteers No
Gender Both
Age group 70 Years and older
Eligibility 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:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Italy Cardiovascular Department, Ospedale S.Donato Arezzo AR

Sponsors (1)
Lead Sponsor Collaborator
Ospedale San Donato

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary in-hospital adverse events incidence until discharge (4-7 days from admission) No
Secondary 12-month adverse events incidence 12 months No
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