NCT06257823

Brief Summary

The ENIGMA study is a single-centre prospective clinical observational study with the aim to investigate vascular contributions to cognitive decline and dementia. By studying MRI-defined capillary dysfunction and EV profiles, the ENIGMA study links novel imaging and basic research techniques to a clinical cohort of stroke patients. With this study we hope to enhance the understanding of the mechanisms behind post-stroke cognitive decline and dementia.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Start

First participant enrolled

April 1, 2021

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

February 6, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 14, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

February 14, 2024

Status Verified

February 1, 2024

Enrollment Period

4.2 years

First QC Date

February 6, 2024

Last Update Submit

February 6, 2024

Conditions

Ischemic StrokeTransient Ischemic Attack

Keywords

DementiaCognitive impairmentMRIExtracellular vesiclesStroke

Outcome Measures

Primary Outcomes (2)

  • Post-stroke cognitive decline

    Change in RBANS index score from three to 12 months follow-up

    12 months

  • Post-stroke cognitive impairment

    Total RBANS index score

    12 months

Secondary Outcomes (4)

  • Post-stroke cognitive decline

    12 months

  • Post-stroke cognitive impairment

    12 months

  • Post-stroke depression

    12 months

  • Physical activity

    12 months

Interventions

No interventionOTHER

No intervention

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients aged ≥ 60 years admitted with AIS or TIA to the comprehensive stroke center at Aarhus University Hospital within 24 hours of symptom onset.

You may qualify if:

  • AIS or TIA with a clinically relevant diffusion restriction identified on MRI DWI-sequence on admission
  • Admittance within 24 hours from symptom onset
  • Age ≥ 60

You may not qualify if:

  • Dependency in activities of daily living (mRS score \> 2)
  • Known dementia, neurodegenerative disease, or other significant brain disease
  • Concomitant life-threatening disease
  • Contraindications to undergo MRI
  • Allergy or intolerance to MRI contrast agents
  • eGFR \< 30
  • Unable to give written informed consent
  • Deemed unfit for follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital

Aarhus, 8000, Denmark

RECRUITING

Related Publications (1)

  • Vestergaard SB, Damsbo AG, Pedersen NL, Zachariassen K, Drasbek KR, Ostergaard L, Andersen G, Dalby RB, Mortensen JK. Exploring vascular contributions to cognitive impairment and dementia (ENIGMA): protocol for a prospective observational study. BMC Neurol. 2024 Apr 3;24(1):110. doi: 10.1186/s12883-024-03601-7.

    PMID: 38570800DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample

MeSH Terms

Conditions

Ischemic StrokeIschemic Attack, TransientDementiaCognitive DysfunctionStroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBrain IschemiaNeurocognitive DisordersMental DisordersCognition Disorders

Study Officials

  • Janne Kaergaard Mortensen, PhD

    Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Janne Kaergaard Mortensen, PhD

CONTACT

+4521156903janne.k.mortensen@clin.au.dk

Sigrid Vestergaard, MD

CONTACT

+4521456903sigrso@rm.dk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, MD, PhD

Study Record Dates

First Submitted

February 6, 2024

First Posted

February 14, 2024

Study Start

April 1, 2021

Primary Completion

June 1, 2025

Study Completion

June 1, 2025

Last Updated

February 14, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will share

All investigators will have access to the entire dataset. Trial metadata, including, but not limited to codebooks, data dictionaries and analysis code will be shared on a repository under a permissive license. Upon completing a collaboration agreement, individual patient trial data may be shared upon reasonable request. Patient data will not be made publicly available.

Shared Documents
STUDY PROTOCOL, ANALYTIC CODE
Time Frame
Not decided
Access Criteria
Upon completing a collaboration agreement, individual patient trial data may be shared upon reasonable request. Patient data will not be made publicly available.

Locations

DK(1)