Circulating circRNA in Acute Ischemic Stroke (CRAST)

Clinical Significance of Circulating circRNA in Acute Ischemic Stroke (CRAST)

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Ischemic Stroke
• Intervention / Treatment: Genetic: Quantitative Real-time polymerase chain reaction

Detailed Description

Circular RNAs have been highlighted to be involved in the pathological process of ischemic stroke (IS). The purpose of this protocol will investigate 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. Distinctive expression patterns of circRNA will be identified by individual quantitative real time polymerase chain reaction (qRT-PCR). A diagnostic or predictive model will be established using logistic regression. The panel of these altered circRNAs may be associated with acute IS and could serve as a novel diagnostic or predictive method.

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Xingzhi Wang, MD; Phone Number: 0086-13852000759; Email: wxz1220@126.com

Study Locations

• China
  • Jiangsu
    • Xuzhou, Jiangsu, China
      • Recruiting
      • Department of Neurology
      • Contact: Xingzhi Wang, MD; Phone Number: 0086-13852000759; Email: wxz1220@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
AIS group; This group includes patients with acute ischemic stroke (AIS).	Genetic: Quantitative Real-time polymerase chain reaction; Quantitative Real-time polymerase chain reaction of circular RNA (circRNA).
HC group; This group includes healthy controls (HC).	Genetic: Quantitative Real-time polymerase chain reaction; Quantitative Real-time polymerase chain reaction of circular RNA (circRNA).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dynamic changes of circRNA during the follow-up period	Dynamic changes of circRNA will be explored before and after endovascular therapy	90 days
Correlation of circRNA and stroke-associated infection	Correlation of circRNA and stroke-associated infection will be explored in acute ischemic stroke.	30 days
Correlation of circRNA and inflammatory factors in acute ischemic stroke	Correlation of circRNA and inflammatory factors on admission will be explored in acute ischemic stroke.	7 days
Prognostic value of circRNA in acute ischemic stroke	The prognosis of AIS patients will be analyzed between differential expressed candidate circRNA after they have completed the systematic therapy.	90 days

Collaborators and Investigators

• Sponsor: The Affiliated Hospital of Xuzhou Medical University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Estimated): October 30, 2024
• Study Completion (Estimated): October 30, 2024

Study Registration Dates

• First Submitted: October 17, 2021
• First Submitted That Met QC Criteria: October 17, 2021
• First Posted (Actual): October 28, 2021

Study Record Updates

• Last Update Posted (Actual): August 6, 2024
• Last Update Submitted That Met QC Criteria: August 4, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: circRNA
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Infarction; Brain Infarction; Stroke; Ischemic Stroke; Ischemia; Cerebral Infarction
• Other Study ID Numbers: XYFY2021-KL107-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No