Circulating Non-coding RNA in Acute Ischemic Stroke With Endovascular Treatment (EVTRNA)

• Sponsor: Nanjing First Hospital, Nanjing Medical University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04230785
• Collaborator: Zhongda Hospital (Other)
• Enrollment: 300
• Location: 1
• Anticipated Duration (Months): 59.5
• Patients Per Site Per Month: 5

Study Details

Study Description

Brief Summary

EVTRNA is to analyze the differentiated expression pattern of circular RNA (circRNA), long non-coding RNA (lncRNA) and micro-RNA (miRNA) by next-generation sequencing in acute ischemic stroke patients before and/or after endovascular treatment. The candidate circRNA/lncRNA/miRNA will be verified as the biomarker and regulator for progression and prognosis of acute ischemic stroke with endovascular treatment. Further, the candidate non-coding RNA will be used to evaluate the effect of endovascular treatment on both peripheral and central immune after stroke.

Condition or Disease	Intervention/Treatment	Phase
Stroke, Acute; Stroke, Ischemic; Endovascular Treatment	Genetic: Sequencing of circRNA/lncRNA/miRNA

Detailed Description

Noncoding RNAs have been highlighted to be involved in the pathological process of ischemic stroke (IS). The purpose of this protocol will investigate the differentiated expression pattern of circular RNA (circRNA), long non-coding RNA (lncRNA) and micro-RNA (miRNA) by next-generation sequencing in acute ischemic stroke patients before and/or after endovascular treatment. The candidate circRNA/lncRNA/miRNA will be verified as the biomarker and regulator for progression and prognosis of acute ischemic stroke with endovascular treatment. Further, the candidate non-coding RNA will be used to evaluate the effect of endovascular treatment on both peripheral and central immune after stroke. Distinctive expression patterns of circRNA/miRNA/lncRNA will be identified by the next-generation sequencing and individual quantitative real time polymerase chain reaction (qRT-PCR). A predictive model will be established using logistic regression. The panel of these altered ncRNAs may be associated with the immune status after acute IS and could serve as a regulator for progression and prognosis of acute ischemic stroke with endovascular treatment.

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 300 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Clinical Significance of Circulating Non-coding RNA in Acute Ischemic Stroke With Endovascular Treatment (EVTRNA)
• Actual Study Start Date: Mar 15, 2020
• Anticipated Primary Completion Date: Mar 1, 2024
• Anticipated Study Completion Date: Mar 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
AIS before EVT group This group includes patients with acute ischemic stroke (AIS) before endovascular treatment (EVT)	Genetic: Sequencing of circRNA/lncRNA/miRNA; Next generation sequencing and quantitative real-time polymerase chain reaction of circular RNA (circRNA), long non-coding RNA (lncRNA) and micro-RNA (miRNA); Other Names: Quantitative Real-time polymerase chain reaction
AIS after EVT group This group includes patients with acute ischemic stroke (AIS) after endovascular treatment (EVT)	Genetic: Sequencing of circRNA/lncRNA/miRNA; Next generation sequencing and quantitative real-time polymerase chain reaction of circular RNA (circRNA), long non-coding RNA (lncRNA) and micro-RNA (miRNA); Other Names: Quantitative Real-time polymerase chain reaction

Outcome Measures

Primary Outcome Measures

1. Differential expression pattern of circRNA/lncRNA/miRNA in acute ischemic stroke patients before and after endovascular treatment [90 days]

   Differential expression pattern of circular RNA (circRNA), long non-coding RNA (lncRNA) and micro-RNA (miRNA) will be compared in acute ischemic stroke patients before and after endovascular treatment, thus candidate circRNA/lncRNA/miRNA will be verified as biomarkers and regulators for progression and prognosis of acute ischemic stroke with endovascular treatment.

Secondary Outcome Measures

1. Prognostic value of circRNA/miRNA/lncRNA in acute ischemic stroke with endovascular treatment [90 days]

   The prognosis of AIS patients will be analyzed between differential expressed candidate circRNA/lncRNA/miRNA after they have endovascular treatment.

2. Correlation of circRNA/lncRNA/miRNA and inflammatory factors in acute ischemic stroke with endovascular treatment [90 days]

   Correlation of circRNA/lncRNA/miRNA and inflammatory factors in acute ischemic stroke before and after endovascular treatment will be explored.

3. Correlation of circRNA/lncRNA/miRNA and stroke-associated infection [90 days]

   Correlation of circRNA/lncRNA/miRNA and stroke-associated infection will be explored in acute ischemic stroke with endovascular treatment.

4. Dynamic changes of circRNA/lncRNA/miRNA during the follow-up period [90 days]

   Dynamic changes of circRNA/lncRNA/miRNA will be explored after endovascular therapy during the follow-up period

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 24 hours of symptom onset and treat with endovascular therapy

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nanjing First Hospital, Nanjing Medical University	Nanjing	Jiangsu	China	210006

Sponsors and Collaborators

• Nanjing First Hospital, Nanjing Medical University
• Zhongda Hospital

Investigators

• Study Chair: Junshan Zhou, M.D, Nanjing First Hospital, Nanjing Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

• Deng QW, Li S, Wang H, Sun HL, Zuo L, Gu ZT, Lu G, Sun CZ, Zhang HQ, Yan FL. Differential long noncoding RNA expressions in peripheral blood mononuclear cells for detection of acute ischemic stroke. Clin Sci (Lond). 2018 Jul 31;132(14):1597-1614. doi: 10.1042/CS20180411. Print 2018 Jul 31.

• Responsible Party: Nanjing First Hospital, Nanjing Medical University
• ClinicalTrials.gov Identifier: NCT04230785
• Other Study ID Numbers: EVTRNA
• First Posted: Jan 18, 2020
• Last Update Posted: Apr 7, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Nanjing First Hospital, Nanjing Medical University: acute ischemic stroke; noncoding RNA; endovascular treatment; clinical significance; outcome
• Additional relevant MeSH terms: Stroke; Ischemic Stroke; Ischemia

Study Results

No Results Posted as of Apr 7, 2022