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COACH-pilot study; COgnition After intraCerebral Hemorrhage

Assessing cognitive function and related small vessel disease markers after intracerebral hemorrhage; a pilot study.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON23317
Enrollment
32
Registered
2021-08-19
Start date
2021-08-19
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intracerebral hemorrhage and dementia

Interventions

N.A.

Sponsors

LUMC
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ICH patients: 1. Age = 55y 2. Ability and willingness to provide written informed consent. 3. Supratentorial ICH with CAAa or HAb as the most likely cause. a CAA-related ICH is defined as an ICH that meets the criteria for definite or probable CAA according to the Modified Boston Criteria (appendix A) b HA-related ICH is defined as ICH located in the basal ganglia, thalamus, or the deep white matter and the presence of hypertension defined as: on treatment for hypertension, or known with high blood pressure (two measurements SBP >140 or DBP >90 mmHg) but not treated for hypertension.

Exclusion criteria

Exclusion criteria: 5.3 Exclusion criteria 1. Age < 55y 2. Unable to provide informed consent. 3. Pre-existing cognitive impairment assessed with the Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE); scores between 53 - 63 reflect pre-existing cognitive mpairment. 4. Contra indications, such as: Contra-indications for 3T MRI and contraindications for lumbar puncture:

Design outcomes

Primary

MeasureTime frame
The main parameters are cognitive decline (according to the neuropsychological assessment) at 12 months.

Secondary

MeasureTime frame
Secondary outcomes are burden of SVD markers on MRI and CSF markers at baseline, at six months and 12 months.

Contacts

Public ContactEllis van Etten

Leiden University Medical Center

e.s.van_etten@lumc.nl071-5263355

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)