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White matter lesions in young to middle aged women with stroke, preeclampsia and migraine: a 7Tesla-study

White matter lesions in young to middle aged women with stroke, preeclampsia and migraine: a 7Tesla-study - WhiSPER-7T

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON55353
Enrollment
160
Registered
2018-11-15
Start date
2019-01-24
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

Ischemic stroke migraine preeclampsia

Interventions

None listed

Sponsors

Leids Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Age between 40 and 60 years - Ability and willingness to provide written informed consent

Exclusion criteria

Exclusion criteria: - Our three patient groups (ischemic stroke, preeclampsia and migraine) are mutually exclusive regarding the defining diagnose, e.g. patients in our ischemic stroke group cannot have a history of migraine and/or preeclampsia. - Contra-indications for 3T (migraine and controls) or 7T MRI (all groups).

Design outcomes

Primary

MeasureTime frame
Primary outcomes are i) distribution of WML (deep versus subcortical) on FLAIR, ii) total burden of SVD markers associated to WML (4 point score for presence or absence of microbleeds, perivascular spaces, lacunar infarcts and microinfarcts), iii) vasoreactivity measured by BOLD change.

Secondary

MeasureTime frame
Secondary/exploratory outcomes are i) total WML volume, ii) number and distribution of microbleeds, small infarctions and enlarged perivascular spaces, iii) pulsatility index measured with 2D Qflow, iv) normal appearing white matter on DTI, v) WML in relation to vascular function of the heart-brain axis, vi) WML in relation to cognitive and mood symptoms. In the women with stroke and the women with preeclampsia the 3T MRI has been performed in the CREW-MIST study (Protocol ID: NL54324.058.15) and is not part of this protocol.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)