the Effects of Cerebral Collateral Circulation on the Outcome of Leukoaraiosis in High-risk Population

Prospective, Single Center, Observational, Clinical Trial of the Effects of Cerebral Collateral Circulation on the Outcome of Leukoaraiosis in High-risk Population

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03246373

Enrollment

1037

Registered

2017-08-11

Start date

2017-10-11

Completion date

2020-12-30

Last updated

2020-07-07

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

Conditions

Leukoaraiosis

Keywords

cognitive impairment

Brief summary

This study observed the relationship between cerebral collateral circulation and the prognosis of leukoaraiosis in high-risk population. Cerebral collateral circulation and leukoaraiosis levels will be evaluated and followed up by magnetic resonance examination. The participants' clinical performance caused by leukoaraiosis will be assessed by a series of scales.

Detailed description

1. Case collection information is sent daily to clinical trial supervisors. 2. The clinical trial team meets once a week to monitor the quality of clinical trials. 3. The severity of the leukoaraiosis will be evaluated by a scale. The patients whose score is more than 2 will take additional magnetic resonance examination including magnetic resonance angiography (MRA) and arterial spin labeling (ASL). And their cognitive ability will be evaluated by a series of scales including Mini-Mental State Examination (MMSE) and Montreal cognitive assessment (MoCA) and gait by the short physical performance battery (SPPB). The blood sample will be taken for biochemical detection and hair and nail samples for trace element detection. 4. Data were analyzed by regression analysis.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

40 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Physical Examinees or out-patients * The MRI scale score ≥ 2

Exclusion criteria

* History of stroke * History of malignant tumor * History of connective tissue disease * Pregnant, trying to become pregnant or within 6 weeks after delivery * serious infections

Design outcomes

Primary

Measure	Time frame	Description
change in cognitive assessment scale score	baseline and one year	It will be assessed by the Mini-Mental state examination (MMSE) and Montreal cognitive assessment (MoCA). Each assessment is scored 0-30, yielding a total between 0-60.

Secondary

Measure	Time frame	Description
change in mood assessment Scale score	baseline and one year	It will be assessed by Hamilton Depression Scale (HAMD). It is scored 0-30.
change in gait evaluation score	baseline and one year	It will be assessed by the short physical performance battery (SPPB). It is scored 0-11.
stroke	baseline and one year	The participant is diagnosed with stroke

Countries

China

Contacts

Primary ContactAnyan Ge

ge.anyan@zs-hospital.sh.cn862164041990

Backup ContactJing Ding

8664041990

Outcome results