NCT02004665

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 24, 2013

Completed
7 days until next milestone

Study Start

First participant enrolled

December 1, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 9, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

December 9, 2013

Status Verified

December 1, 2013

Enrollment Period

1.9 years

First QC Date

November 24, 2013

Last Update Submit

December 4, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

  • in-hospital adverse events incidence

    until discharge (4-7 days from admission)

Secondary Outcomes (1)

  • 12-month adverse events incidence

    12 months

Study Arms (1)

acute coronary syndrome and delirium

patients with acute coronary syndrome and delirium

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

patients with acute coronary syndrome and delirium

You may qualify if:

  • 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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiovascular Department, Ospedale S.Donato

Arezzo, AR, 52100, Italy

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

DeliriumAcute Coronary Syndrome

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental DisordersMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

November 24, 2013

First Posted

December 9, 2013

Study Start

December 1, 2013

Primary Completion

November 1, 2015

Study Completion

November 1, 2016

Last Updated

December 9, 2013

Record last verified: 2013-12

Locations