Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06240468 |
| Other study ID # |
CALM2003 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 10, 2022 |
| Est. completion date |
December 30, 2025 |
Study information
| Verified date |
May 2023 |
| Source |
Zhujiang Hospital |
| Contact |
Mengxi Li |
| Phone |
15013048680 |
| Email |
1135621389[@]qq.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
(1) The main purpose
To explore the predictive value of human microbiome and its metabolome for adverse prognosis
in patients with acute ischemic stroke (AIS).
(2) Secondary purposes
1. To explore the characteristics of cross-regional disturbance of human microbiome in
stroke patients;
2. To investigate the characteristics and rules of bacterial flora changes before and after
recurrent apoplexy;
3. Markers closely related to AIS prognosis and cognitive emotional complications were
excavated by metagenomic, metabolic, peptide and imaging groups.
4. To explore the relationship between serum markers of ultra early stage and prognosis.
Description:
This is a multicenter, prospective clinical cohort study. In this study, 2000 patients with
AIS were continuously enrolled in a multicenter study, and neurological function scores
(including NIHSS, mRS And ADL scores) were evaluated during and after hospitalization (3
months, 6 months, 12 months) by outpatient/telephone follow-up, and recurrent stroke and
other cardiovascular and cerebrovascular events were recorded. Besides, periodontal swabs,
urine, feces and blood samples were collected at multiple time points (Residual blood after
the first clinical examination was collected for patients with very early stage, and blood,
urine, feces and periodontal swabs were collected the next day after admission, before
discharge, 3 months and 6 months after admission. Since the collection time of fecal
specimens is difficult to control, only two specimens should be collected 48 hours apart
during hospitalization. The first specimen should be collected as early as possible, and the
time of specimen separation should be recorded.
Baseline data collection and discharge neurological function score were completed for the
enrolled AIS patients before discharge, and the final diagnosis, stroke etiology
classification, lifestyle survey (1 year ago), and relevant examination and treatment during
hospitalization were recorded. Neurological function score, lifestyle survey, new
cardiovascular and cerebrovascular events and biological specimen collection (blood, urine,
feces, periodontal swab) were recorded during outpatient visits 3 months and 6 months after
admission. Telephone follow-up was conducted 12 months after admission, mRS Score, ADL score
and new cardiovascular and cerebrovascular events were recorded.
For the patients (750 cases) who met the criteria for inclusion in the cognitive emotion
subcohort, outpatient emotional and cognitive psychological assessment was also required
before discharge, 3 months and 6 months after admission on the basis of the AIS cohort.
For the subcohort with recurrence within 1 year, only data collection during hospitalization
(baseline hospitalization data) and biological specimen collection during hospitalization
(residual blood after the first laboratory examination was retained for patients in the very
early stage, and blood, urine, feces, and periodontal swabs were collected the next day after
admission and before discharge. As the time of fecal sample collection is difficult to
control, it only needs to be 48 hours between hospitalization), and no follow-up will be
conducted after discharge.
In addition, 500 patients without stroke were recruited as healthy control group according to
the prescribed inclusion criteria.
No randomization or any study protocol-driven treatment will be administered or provided to
the subject during the study. If clinically applicable, treatment decisions and treatment
options are made at the discretion of the treating physician.
