NCT04978701

Brief Summary

Recent studies have found a close relationship between acute ischemic stroke(AIS) and gut microbiota, but whether the dynamic changes in human microbiome after stroke can predict poor prognosis of stroke remains unclear. Therefore, we planned to explore the predictive value of human microbiome and its metabolites in stroke prognosis through a multicenter cohort study

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 20, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 27, 2021

Completed
5 days until next milestone

Study Start

First participant enrolled

August 1, 2021

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

November 12, 2021

Status Verified

November 1, 2021

Enrollment Period

3.4 years

First QC Date

July 20, 2021

Last Update Submit

November 11, 2021

Conditions

Acute Ischemic Stroke

Keywords

acute ischemic stroke, microbiome, prognosis

Outcome Measures

Primary Outcomes (3)

  • modified Rankin Scale

    An evaluation of neurological deficits

    3 months after the onset

  • National Institute of Health stroke scale

    An evaluation of neurological deficits

    3 months after the onset

  • Major ischemic events

    Major ischemic event is defined as ischemic stroke, myocardial infarction, or death from an ischemic vascular event.

    within 3 months

Secondary Outcomes (6)

  • modified Rankin Scale

    6 months after the onset

  • National Institute of Health stroke scale

    6 months after the onset

  • Major ischemic events

    within 6 months

  • modified Rankin Scale

    12 months after the onset

  • National Institute of Health stroke scale

    12 months after the onset

  • +1 more secondary outcomes

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who met the eligibility criteria for acute ischemic stroke

You may qualify if:

  • Meet the AIS diagnostic criteria;
  • Age 18-80;
  • Within 7 days of the onset;
  • Signing the informed consent, providing relevant medical history and biological specimens.

You may not qualify if:

  • mRS \> score 2 before onset;
  • Serious systemic diseases including malignant tumors;
  • Hematological diseases and autoimmune diseases;
  • ALT or AST \> 2 times the upper limit of normal value or severe liver disease;
  • Serum creatinine \> 1.5 times the upper normal limit or severe nephropathy;
  • History of alcoholism, drug abuse, and chemical poisoning (e.g. pesticide poisoning);
  • History of intestinal tumor, irritable bowel syndrome or inflammatory bowel disease or confirmed in hospital;
  • Antibiotic use within 1 month before admission;
  • Fece cannot be obtained within 4 days after admission.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurology, NanFang Hospital, Southern Medical University

Guanzhou, Guangdong, 510515, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood plasm；Faeces；Oral swabs

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Yin Jia, Master

    Department of Neurology, NanFang Hospital, Southern Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yin Jia, Master

CONTACT

+86 13802964883jiajiayin@139.com

Zhang Mingsi, Master

CONTACT

+86 13827003570meens19@qq.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Physician

Study Record Dates

First Submitted

July 20, 2021

First Posted

July 27, 2021

Study Start

August 1, 2021

Primary Completion

December 31, 2024

Study Completion

June 30, 2025

Last Updated

November 12, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)