NCT06759259

Brief Summary

The aim of the study is to evaluate the efficacy of adjuvant administration of mannitol for the prevention of delirium in patients with myocardial infarction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

December 28, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

December 29, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 6, 2025

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

December 9, 2025

Status Verified

December 1, 2025

Enrollment Period

1 month

First QC Date

December 28, 2024

Last Update Submit

December 8, 2025

Conditions

Myocardial Infarction (MI)Delirium, Intensive Care Unit, Randomised Controlled Trial

Keywords

myocardial infarctiondeliriumpreventioninflammation

Outcome Measures

Primary Outcomes (1)

  • delirium

    Development of delirium during hospitalization

    1-14 days

Secondary Outcomes (4)

  • In-hospital mortality

    1-30 days

  • In-hospital LOS

    1-30 lays

  • ICU-LOS

    1-30 days

  • Re-hospitalization due to MACE

    1-90 days

Other Outcomes (3)

  • Dynamics of brain damage markers

    1, 3, 7 days

  • Dynamics of markers of systemic inflammation

    1, 3, 7 days

  • Early adverse LV remodeling

    1, 3, 7 days

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients in the first day of development of myocardial infarction with signs of systemic inflammation and initial normal mental status and the absence of previously known pathological processes of the brain and psychiatric disorders.

You may qualify if:

  • Age 65 and over
  • Myocardial infarction in the first day of illness ("pain to door" time \< 254 hours)
  • Serum CRP \> 25 mg/L

You may not qualify if:

  • A known pathological process in the brain, psychiatric disorders
  • Impossibility of conducting an assessment CAM-ICU

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiology Reserch Institute Tomsk National Research Centre

Tomsk, Tomsk Oblast, 634012, Russia

Location

MeSH Terms

Conditions

Myocardial InfarctionDeliriumInflammation

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsNeurocognitive DisordersMental Disorders

Study Officials

  • Oleg Panteleev, MD

    Tomsk NRMC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 28, 2024

First Posted

January 6, 2025

Study Start

December 29, 2024

Primary Completion

February 1, 2025

Study Completion

October 1, 2025

Last Updated

December 9, 2025

Record last verified: 2025-12

Locations

RU(1)