Ignite Creation Date:
2024-05-06 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06257823
Status:
RECRUITING
Last Update Posted:
2024-02-14
First Post:
2024-02-06
Brief Title:
Vascular Cognitive Decline and Dementia
Sponsor:
Aarhus University Hospital
Organization:
Aarhus University Hospital
Study Overview
Official Title:
Exploring Vascular Contributions to Cognitive Decline and Dementia
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ENIGMA
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None