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

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ClinicalTrials.gov Identifier: NCT02004665
Recruitment Status : Unknown
Verified December 2013 by Leonardo Bolognese, MD, Ospedale San Donato.
Recruitment status was:  Recruiting
First Posted : December 9, 2013
Last Update Posted : December 9, 2013
Sponsor:
Information provided by (Responsible Party):
Leonardo Bolognese, MD, Ospedale San Donato

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

Condition or disease
Delirium Acute Coronary Syndrome

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Incidence and Prognostic Value of DELIRIUM in Patients With Acute CORonary synDrome: an observatIonal Study by the DELIRIUM-CORDIS Investigators.
Study Start Date : December 2013
Estimated Primary Completion Date : November 2015
Estimated Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

Group/Cohort
acute coronary syndrome and delirium
patients with acute coronary syndrome and delirium



Primary Outcome Measures :
  1. in-hospital adverse events incidence [ Time Frame: until discharge (4-7 days from admission) ]

Secondary Outcome Measures :
  1. 12-month adverse events incidence [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients with acute coronary syndrome and delirium
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02004665


Locations
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Italy
Cardiovascular Department, Ospedale S.Donato Recruiting
Arezzo, AR, Italy, 52100
Contact: Giovanni Falsini, MD       giovannifalsini@gmail.com   
Principal Investigator: Leonardo Bolognese, MD, FESC         
Principal Investigator: Giovanni Falsini, MD         
Sponsors and Collaborators
Ospedale San Donato

Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Leonardo Bolognese, MD, Director, Ospedale San Donato
ClinicalTrials.gov Identifier: NCT02004665     History of Changes
Other Study ID Numbers: Arezzo012
First Posted: December 9, 2013    Key Record Dates
Last Update Posted: December 9, 2013
Last Verified: December 2013

Additional relevant MeSH terms:
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Delirium
Acute Coronary Syndrome
Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders