Establishment of magnetic resonance imaging biomarkers for detection of early disease progression and identification of therapeutic strategies in cerebral small vessel disease (SVD)

Establishment of magnetic resonance imaging biomarkers for detection of early disease progression and identification of therapeutic strategies in cerebral small vessel disease (SVD) - EARLYPROG-SVD

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00034274

Enrollment

100

Registered

2026-01-12

Start date

2022-07-29

Completion date

Unknown

Last updated

2026-04-27

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

Conditions

I67.3

Interventions

Group 1: Arm 1: Patients with cerebral microangiopathy (n ˜ 50) are assessed with respect to cerebral imaging findings, clinical-neurological status, and cognitive status. Examinations are performed p

however, data processing, analysis, and statistical evaluation are performed in a blinded manner. Group 2: Arm 2: Control group – participants without cerebral microangiopathy or Fazekas less than or

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Evidence of microangiopathic white matter changes consistent with CSVD (CSVD-typical symptoms or events are NOT required for inclusion), or no/minimal imaging changes in control participants (Fazekas = 1) - Men and women > 18 years of age - Capacity to provide informed consent is present - Patients/participants have been informed about the purpose, benefits, and risks of the examination beforehand - Written informed consent regarding data collection and study participation has been obtained from all patients/participants

Exclusion criteria

Exclusion criteria: - Conventional contraindications that prevent the performance of an MRI examination: - Ferromagnetic metallic implants (e.g. metal fragments, metal plates or screws, cochlear implant, hormonal intrauterine device, clips after surgery, …) - Cardiac pacemaker - Neurostimulator - Infusion pump - Tattoos, permanent make-up - Retainer or fixed dental prostheses/implants made of metal - Claustrophobia - Fever - Pregnancy - Evidence of a competing intracranial pathology, e.g. intracranial mass lesion, severe traumatic brain injury, intracerebral hemorrhage, embolic cerebral infarcts, vasculitis-typical changes - Evidence of a hemodynamically relevant stenosis of a brain-supplying artery - Subjects/patients who are unable to provide informed consent

Design outcomes

Primary

Measure	Time frame
I. To measure quantitative MRI parameters (T1, T2, T2*, T2', FLAIR) as well as structural connectivity (DTI with fiber tracking) of the white matter in 50 patients with cerebral microangiopathy and 50 age- and sex-matched control participants using 3 Tesla MRI. II. To characterize the temporal course of these MRI parameters, including their variance, mutual associations, and patterns of progression. III. To investigate the association of MRI parameters with clinical–neurological status and cognitive status (CERAD-Plus). All target variables are collected prospectively at each study visit (baseline, 6 months, 12 months, and thereafter annually until 2027) and analyzed in a blinded, longitudinal statistical framework (including correlation and regression analyses and models for repeated measures) to assess temporal dynamics and relationships between imaging, clinical, and cognitive measures.	—

Measure

Time frame

I. To measure quantitative MRI parameters (T1, T2, T2*, T2', FLAIR) as well as structural connectivity (DTI with fiber tracking) of the white matter in 50 patients with cerebral microangiopathy and 50 age- and sex-matched control participants using 3 Tesla MRI. II. To characterize the temporal course of these MRI parameters, including their variance, mutual associations, and patterns of progression. III. To investigate the association of MRI parameters with clinical–neurological status and cognitive status (CERAD-Plus). All target variables are collected prospectively at each study visit (baseline, 6 months, 12 months, and thereafter annually until 2027) and analyzed in a blinded, longitudinal statistical framework (including correlation and regression analyses and models for repeated measures) to assess temporal dynamics and relationships between imaging, clinical, and cognitive measures.

—

Secondary

Measure	Time frame
I. To test for a potential correlation of MRI parameters with demographic characteristics and vascular risk factors (age, sex, mean systolic and diastolic blood pressure, ongoing or discontinued tobacco use, diabetes mellitus) as well as laboratory findings (lipid profile, HbA1c, serum creatinine level, and glomerular filtration rate). II. To assess the correlation of the acquired parameters with the extent and progression of conventional imaging findings (white matter lesions, lacunar and small subcortical infarcts, microbleeds, enlarged perivascular spaces, and brain volume loss).	—

Measure

Time frame

I. To test for a potential correlation of MRI parameters with demographic characteristics and vascular risk factors (age, sex, mean systolic and diastolic blood pressure, ongoing or discontinued tobacco use, diabetes mellitus) as well as laboratory findings (lipid profile, HbA1c, serum creatinine level, and glomerular filtration rate). II. To assess the correlation of the acquired parameters with the extent and progression of conventional imaging findings (white matter lesions, lacunar and small subcortical infarcts, microbleeds, enlarged perivascular spaces, and brain volume loss).

—

Countries

Germany

Contacts

Public ContactFranziska Frank

Universitäsklinikum Frankfurt

frank@med.uni-frankfurt.de0049 696301 95626

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: May 1, 2026