Ischemic StrokeENIGMANCT06257823
Vascular Cognitive Decline and Dementia
An observational study of Ischemic Stroke and Transient Ischemic Attack, run by Aarhus University Hospital at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Ischemic Stroke, Transient Ischemic Attack
- How many people
- 140 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Apr 2021to 1 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Aarhus University Hospital
Aarhus, 8000
Janne Kaergaard Mortensen, PhD, +4521156903, janne.k.mortensen@clin.au.dk
Sigrid Vestergaard, MD, +4521456903, sigrso@rm.dk
About this study
Official title: Exploring Vascular Contributions to Cognitive Decline and Dementia
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.
Read the detailed description
Post-stroke cognitive impairment (PSCI) is common. However, the underlying pathophysiology remains largely unknown. Understanding how microvascular changes relate to PSCI and finding markers that can predict PSCI, could be a first step towards better screening and management.
Cerebral capillary dysfunction is characterized by limited oxygen extraction from the brain capillaries due to age- and risk factor-related capillary flow heterogeneity. Capillary dysfunction is a pathophysiological feature of cerebral small vessel disease (cSVD) and may play an important role in the vascular mechanisms underlying PSCI. Extracellular vesicles (EVs) carry molecules between cells. EV profiles may change during acute stroke, in the chronic stroke phase, and according to the level of cSVD, and EV profiles may therefore act as disease biomarkers.
The ENIGMA study aims to investigate capillary dysfunction and EV profiles as predictors of cognitive function one year after acute ischemic stroke (AIS) and transient ischemic attack (TIA). Consecutive patients with AIS and TIA are included and followed for one year with follow-up visits at three and 12 months. An MRI is performed at 24 hours and 12 months after admission. EV profiles will be characterised from blood samples drawn at 24 hours and three months after admission. Cognitive function is assessed three and 12 months after AIS and TIA using the Repeatable Battery for the Assessment of Neuropsychological Status and the Montreal Cognitive Assessment (MoCA).
The study has two main objectives: 1) to study associations between capillary dysfunction and PSCI and 2) to assess associations between EV profiles and PSCI.
- Conditions
- Ischemic Stroke, Transient Ischemic Attack
- Being tested
- No intervention
- Keywords
- Dementia, Cognitive impairment, MRI, Extracellular vesicles, Stroke
- Medical subject headings
- Ischemic Stroke, Ischemic Attack, Transient, Dementia, Cognitive Dysfunction, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-stroke cognitive decline
Change in RBANS index score from three to 12 months follow-up
Measured: 12 months
Post-stroke cognitive impairment
Total RBANS index score
Measured: 12 months
Secondary outcomes (4)
Post-stroke cognitive decline
Change in MoCA score from three to 12 months follow-up
Measured: 12 months
Post-stroke cognitive impairment
MoCA score at 12 months follow-up
Measured: 12 months
Post-stroke depression
Measured on the major depression inventory
Measured: 12 months
Physical activity
Measured on the Physical Activity Scale for the Elderley
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start1 Apr 2021
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Aarhus
- Responsible party
- Principal investigator, Janne Kaergard Mortensen, Aarhus University Hospital
- Investigators
- Janne Kaergaard Mortensen, PhD, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06257823
- Sponsor's protocol ID
- 1-10-72-253-20
- Acronym
- ENIGMA
- Status last verified
- Feb 2024
- First submitted
- 6 Feb 2024
- Last updated
- 14 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 38570800
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Vascular Contributions to Cognitive Decline and Dementia
- ClinicalTrials.gov ID
- NCT06257823
- Acronym / sponsor ID
- ENIGMA / 1-10-72-253-20
- Conditions
- Ischemic Stroke, Transient Ischemic Attack
- Keywords
- Dementia, Cognitive impairment, MRI, Extracellular vesicles, Stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- University of Aarhus
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 14 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Post-stroke cognitive impairment (PSCI) is common. However, the underlying pathophysiology remains largely unknown. Understanding how microvascular changes relate to PSCI and finding markers that can predict PSCI, could be a first step towards better screening and management.
Cerebral capillary dysfunction is characterized by limited oxygen extraction from the brain capillaries due to age- and risk factor-related capillary flow heterogeneity. Capillary dysfunction is a pathophysiological feature of cerebral small vessel disease (cSVD) and may play an important role in the vascular mechanisms underlying PSCI. Extracellular vesicles (EVs) carry molecules between cells. EV profiles may change during acute stroke, in the chronic stroke phase, and according to the level of cSVD, and EV profiles may therefore act as disease biomarkers.
The ENIGMA study aims to investigate capillary dysfunction and EV profiles as predictors of cognitive function one year after acute ischemic stroke (AIS) and transient ischemic attack (TIA). Consecutive patients with AIS and TIA are included and followed for one year with follow-up visits at three and 12 months. An MRI is performed at 24 hours and 12 months after admission. EV profiles will be characterised from blood samples drawn at 24 hours and three months after admission. Cognitive function is assessed three and 12 months after AIS and TIA using the Repeatable Battery for the Assessment of Neuropsychological Status and the Montreal Cognitive Assessment (MoCA).
The study has two main objectives: 1) to study associations between capillary dysfunction and PSCI and 2) to assess associations between EV profiles and PSCI.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | – |
Primary outcome
Post-stroke cognitive decline
Time frame: 12 months
Change in RBANS index score from three to 12 months follow-up
Post-stroke cognitive impairment
Time frame: 12 months
Total RBANS index score
4 secondary outcomes
Post-stroke cognitive decline
Time frame: 12 months
Post-stroke cognitive impairment
Time frame: 12 months
Post-stroke depression
Time frame: 12 months
Physical activity
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
- Derived from this study: PubMed 38570800Vestergaard 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janne Kaergaard Mortensen, PhD principal investigator
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke and Transient Ischemic Attack, run by Aarhus University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Janne Kaergaard Mortensen, PhD (+4521156903, janne.k.mortensen@clin.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-stroke cognitive decline (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06257823, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2024.