NCT05410457

Brief Summary

AISDTS is a prospective registry study, in which clinical information, examination and imaging data of patients with acute ischemic stroke receiving different treatment strategies were collected, grouped and statistically analyzed, and corresponding clinical prediction models were constructed to explore the role of clinical biological indicators in the occurrence and development of stroke.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
13mo left

Started May 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress80%
May 2022Jun 2027

Study Start

First participant enrolled

May 24, 2022

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

May 26, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 8, 2022

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 24, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 24, 2027

Last Updated

April 9, 2026

Status Verified

January 1, 2026

Enrollment Period

5.1 years

First QC Date

May 26, 2022

Last Update Submit

April 6, 2026

Conditions

Ischemic Stroke

Keywords

ischemic strokeclincial indicatorsthrombolysisthrombectomyneuroimaginggeneticsone-stop multimodal-MRIstroke related complications

Outcome Measures

Primary Outcomes (2)

  • To assess the changes of prognosis of stroke patients under different treatment strategies

    assessed by The Modified Rankin Score (mRS) of stroke patients \[mild to wores ranging from 0 to 5, 6 represents death\].

    3 months, 6 months, 12 months or 24 months

  • To assess the early neurological changes of ischemic stroke

    change from baseline National Institute of Health stroke scalescore (NIHSS) \[higher scores mean worse conditions\]7 days or 14 days

    7 days or 14 days

Secondary Outcomes (4)

  • To assess the incidence of recurrent stroke under different treatment strategies

    7 days-24 months

  • To assess the types and incidence of adverse events of ischemic stroke patients

    3 days-24 months

  • To assess the correlation of RNA/DNA and age factor in acute ischemic stroke

    3 months

  • To assess the therapeutical effects of Edaravone dexborneol on inflammation and prognosis after acute ischemic stroke

    3 months

Study Arms (6)

thrombolysis group

Inclusion criteria: a) age ≥18 years; B) hospital admission for acute ischemic stroke; C) the time from onset to admission ≤ 4.5 hours; D) received intravenous thrombolysis; E) signed informed consent.

thrombectomy group

Inclusion criteria: a) age ≥18 years; B) hospital admission for acute ischemic stroke; C) the time from onset to admission ≤ 24 hours; D) vascular assessment by CTA or multimodal MRI; E) received thrombectomy; F) signed informed consent.

stent group

Inclusion criteria: a) age ≥18 years; B) hospital admission due to ischemic stroke; C) vascular assessment by CTA or multimodal MRI; D) received stent implantation ; E) Signed informed consent.

regular treatment group

Inclusion criteria: a) age ≥18 years; B) hospital admission due to ischemic stroke; C) received regular medical treatment; D) signed informed consent.

young stroke group

Inclusion criteria: a) age between 18 and 50 years of age (45/55Y); B) hospital admission due to ischemic stroke; C) received CT or MRI imaging assessment; D) signed informed consent.

unexplained stroke group

Inclusion criteria: a) age ≥18 years; B) hospital admission due to ischemic stroke; C) Received CT or MRI imaging assessment; D)TOAST was classified as unknown cause type (including two or more causes and no cause was found by auxiliary examination); E) signed informed consent.

Eligibility Criteria

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

Patients admitted to hospital for ischemic stroke were enrolled.

You may qualify if:

  • A) ≥18 years of age; B) hospital admission for ischemic stroke; C) Signed informed consent.

You may not qualify if:

  • A) patients with incomplete clinical information; B) hospitalization observation time less than 24 hours; C) recent trauma, severe inflammation, severe liver and kidney dysfunction, progressive malignance and other serious diseases; D) baseline mRS score\>2; E) informed consent is not signed.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanjing First Hospital, Nanjing Medical University

Nanjing, Jiangsu, 210006, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples were collected from routine blood sample.

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Qiwen Deng, M.D.

CONTACT

+86025-87726218qiw_deng@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2022

First Posted

June 8, 2022

Study Start

May 24, 2022

Primary Completion (Estimated)

June 24, 2027

Study Completion (Estimated)

June 24, 2027

Last Updated

April 9, 2026

Record last verified: 2026-01

Locations

CN(1)