Incidence and Prognostic Value of DELIRIUM in Patients Wi... | NCT02004665

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

NCT02004665

Sponsor

Ospedale San Donato

Status

Unknown status

Last Update Posted

Dec 9, 2013Estimated

Enrollment

400Estimated

Phase

Not provided

Conditions

Delirium
Acute Coronary Syndrome

Interventions

Not provided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2013

Primary Completion Date

Nov 2015Estimated

Completion Date

Nov 2016Estimated

First Submitted Date

Nov 24, 2013

First Submission Date that Met QC Criteria

Dec 4, 2013

First Posted Date

Dec 9, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 4, 2013

Last Update Posted Date

Dec 9, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

12 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

400Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
acute coronary syndrome and delirium		patients with acute coronary syndrome and delirium

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
12-month adverse events incidence		12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

70 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

patients with acute coronary syndrome and delirium

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cardiovascular Department, Ospedale S.Donato	Recruiting	Arezzo	AR	52100	Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29064263	Derived	Falsini G, Grotti S, Porto I, Toccafondi G, Fraticelli A, Angioli P, Ducci K, Liistro F, Pieroni M, Taddei T, Romanelli S, Rossi R, Bolognese L. Long-term prognostic value of delirium in elderly patients with acute cardiac diseases admitted to two cardiac intensive care units: a prospective study (DELIRIUM CORDIS). Eur Heart J Acute Cardiovasc Care. 2018 Oct;7(7):661-670. doi: 10.1177/2048872617695235. Epub 2017 Mar 16.

Type	Date	Date Unknown
Release	Mar 2, 2023
Reset	Dec 8, 2023

ID	Term
D003221	Confusion
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

ID	Term
D003693	Delirium
D054058	Acute Coronary Syndrome