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NCT Number: NCT05677607

Feedback Loop Between Intracranial Atherosclerosis and Cerebral Small Vessel Disease

The present study aims at verifying the mutual effects between intracranial large artery atherosclerosis and cerebral small vessel disease on disease progression and prognosis by magnetic resonance imaging, and providing biomarkers for the early prevention and treatment of cerebrovascular disease.

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Key information

Age range

30 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location status: Recruiting

Location contact

Jinhao Lyu, MD

CONTACT

[email protected]

About this study

Cerebrovascular disease is the most common cause of death worldwide. There is a close link in structure and function between the intracranial large arteries and cerebral small vessels. Moreover, growing evidences have demonstrated that large artery atherosclerosis often coexists with small vessel disease, which may deteriorate the clinical outcomes of stroke and dementia. The mutual feedback mechanism between them is not fully understood. The present study focuses on the mechanism of mutual feedback between large artery atherosclerosis and cerebral small vessel disease by using magnetic resonance imaging. The study may provide biomarkers for the early prevention and treatment of cerebrovascular disease.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years
  • At least one intracranial artery ≥ 50% atherosclerotic stenosis
  • Modified Rankin Scale < 2
  • Mini-mental State Examination > 24

Exclusion criteria

  • Concurrent ipsilateral extracranial artery ≥ 50% stenosis
  • Pregnant women
  • Contraindications to magnetic resonance examination (patients with pacemakers, nerve stimulators, artificial metal heart valves and other metal foreign bodies)

Treatment and study plan

Magnetic Resonance Imaging

Diagnostic Test

Imaging diagnostics mainly based on Magnetic resonance imaging.

Primary outcomes

  1. Progression in total cerebral small vessel disease burden

    Time frame: 1-3 YEARS

    Total cerebral small vessel disease burden is assessed according to a sum of scores of white matter hyperintensity, cerebral microbleeds, lacunes and enlarged perivasular spaces on magnetic resonance imaging sequences.

  2. Frequency of stroke recurrence

    Time frame: 1-3 YEARS

    The percentage of symptomatic participants who suffer from stroke recurrence after enrollment in the territory of the targeted stenotic vessel.

Secondary outcomes

  1. Frequency of stroke of asymptomatic participants

    Time frame: 1-3 YEARS

    The percentage of asymptomatic participants who suffer from stroke after enrollment in the territory of the targeted stenotic vessel.

Study contacts

Contact information is provided by the study sponsor or research team.

Jinhao Lyu

CONTACT

[email protected]

+8615903562929

Sponsors and collaborators

Lead sponsor

Chinese PLA General Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jan 10, 2023
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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