Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT06170086 |
| Other study ID # |
brain acute ischemic stroke |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2023 |
| Est. completion date |
September 1, 2028 |
Study information
| Verified date |
December 2023 |
| Source |
Chinese PLA General Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Prospective identification of potential responsible blood vessels, provision of intervention
targets, prevention of fatal and disabling cerebrovascular diseases, identification of early
END patients, determination of clinical treatment pathways, improvement of efficacy, and
improvement of prognosis
Description:
1. Research background： Stroke is divided into ischemic stroke and hemorrhagic stroke, with
ischemic stroke accounting for about 70% and being the main type of stroke. The branch
atherosclerotic disease (BAD) accounts for 10%~15% of all acute ischemic stroke (ALS),
mainly involving lenticular artery (LSA), parapontine median artery (PPA), thalamic
geniculate body artery, anterior choroidal artery Heubner's artery and thalamic
perforating artery. Its clinical symptoms often manifest as early neurological
deterioration (END), mainly progressive motor dysfunction (PDM), within 48 to 72 hours
of onset, with an incidence rate of approximately 17% -75%. The clinical prognosis is
poor.
2. The purpose and significance of the research Prospective identification of potential
responsible blood vessels, provision of intervention targets, prevention of fatal and
disabling cerebrovascular diseases, identification of early END patients, determination
of clinical treatment pathways, improvement of efficacy, and improvement of prognosis
3. Research contents 1) Research on the relationship between stroke responsibility vessels
and the pathogenesis of END in patients based on magnetic resonance three-dimensional
time leap vascular imaging technology; 2) The impact of clinical interventions
(intravenous thrombolysis, antiplatelet therapy, anticoagulation, statins,
neuroprotective drugs, etc.) on END
4. Patient inclusion and exclusion criteria inclusion criteria
1. Acute perforating atherosclerotic stroke patients within 48 hours of onset;
2. Age ≥ 18 years and ≤ 80 years old;
3. Having two or more vascular risk factors, including hypertension, diabetes,
coronary heart disease, hyperlipidemia, smoking and obesity;
4. Sign informed consent form exclusion criteria
1. Patients with large artery stroke;
2. Contraindications to magnetic resonance imaging or pregnant women;
3. Other vascular lesions, such as aneurysms, vascular dissection, vasculitis, and
brain tumors
5. Research method Select and treat emergency stroke patients according to the research
design requirements, record clinical data, and evaluate the timing of 7T MRI. The
patient underwent 7T MRI examination within 24 hours after the first diagnosis of acute
stroke of the perforating artery, within 24 hours after aggravation, and 2 weeks after
treatment according to the consensus of Chinese experts on perforating artery
atherosclerosis. The sequences involved include: T1, T2flair, DWI, ADC, SWI, MRA, and
high-resolution MRI of the responsible carrier artery (including cross section and
longitudinal section). Collect original image images, search for the responsible
perforating artery for stroke, calculate baseline core infarct volume (DWI), aggravated
core infarct volume (DWI), and final infarct volume (T2 flair) after 2 weeks of
treatment. Clinical evaluation baseline and NIHSS score after 3 months, to explore the
relationship between responsible blood vessels and core infarct volume and NIHSS score.
6. Data statistical methods Measurement data that follow a normal distribution are
expressed in the form of mean ± standard deviation, while non normal distribution
measurement data are expressed in the form of median (25% percentile -75% percentile).
Inter group comparison of econometric data with normal distribution and homogeneity of
variance, using t-test or analysis of variance; The Wilcoxon rank sum test is used for
inter group comparison of non normal distribution econometric data. The chi square test
is used for inter group comparison of count data. Correlation analysis uses either
Person correlation analysis or Spearman correlation analysis. The consistency test
between methodologies was conducted using Kappa test.
