NCT05098340

Brief Summary

CRAST is to analyze the expression pattern of circular RNA (circRNA) by bioinformatics analysis in patients with acute ischemic stroke and healthy control. The candidate circRNA will be verified as biomarkers for the detection and prognosis of acute ischemic stroke.

Trial Health

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Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2020

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2020

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

October 17, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 28, 2021

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2024

Completed
Last Updated

August 6, 2024

Status Verified

August 1, 2024

Enrollment Period

4.1 years

First QC Date

October 17, 2021

Last Update Submit

August 4, 2024

Conditions

Keywords

circRNA

Outcome Measures

Primary Outcomes (1)

  • Differential expression pattern of circRNA

    Differential expression pattern of circular RNA (circRNA) will be compared between AIS group and HC group, thus candidate circRNA will be verified as biomarkers for the detection and prognosis of AIS.

    90 days

Secondary Outcomes (4)

  • Dynamic changes of circRNA during the follow-up period

    90 days

  • Correlation of circRNA and stroke-associated infection

    30 days

  • Correlation of circRNA and inflammatory factors in acute ischemic stroke

    7 days

  • Prognostic value of circRNA in acute ischemic stroke

    90 days

Study Arms (2)

AIS group

This group includes patients with acute ischemic stroke (AIS).

Genetic: Quantitative Real-time polymerase chain reaction

HC group

This group includes healthy controls (HC).

Genetic: Quantitative Real-time polymerase chain reaction

Interventions

Quantitative Real-time polymerase chain reaction of circular RNA (circRNA).

AIS groupHC group

Eligibility Criteria

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

There will be 100 patients suspected of AIS (such as transient ischemic attack), 300 AIS patients and 100 Healthy controls,whose data will be applied for construction and validation of diagnostic and predictive models of circRNA from the circulating blood.

You may qualify if:

  • Aged 18 years or older
  • Confirmed acute ischemic stroke by a diffusion-weighted imaging-position lesion on magnetic resonance imaging (MRI) and a new lesion on a brain computed tomography (CT) scan
  • Within 72 hours of symptom onset
  • Good performance status
  • Signed an approved informed consents

You may not qualify if:

  • a history of hemorrhagic infarction, chronic kidney/liver diseases, peripheral arterial occlusive disease, active malignant disease, and inflammatory or infectious diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurology

Xuzhou, Jiangsu, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

An 10 ml peripheral venous blood will be collected from the participants before and after interventions (i.e. intravenous thrombolysis and/or endovascular therapy)

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Real-Time Polymerase Chain Reaction

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Polymerase Chain ReactionNucleic Acid Amplification TechniquesGenetic TechniquesInvestigative Techniques

Central Study Contacts

Xingzhi Wang, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
90 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2021

First Posted

October 28, 2021

Study Start

October 1, 2020

Primary Completion

October 30, 2024

Study Completion

October 30, 2024

Last Updated

August 6, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations