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Identification of microRNAs Involved in Cerebral Collateral Regulation (microRNA)

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ClinicalTrials.gov Identifier: NCT03905434
Recruitment Status : Recruiting
First Posted : April 5, 2019
Last Update Posted : April 5, 2019
Sponsor:
Information provided by (Responsible Party):
Shraddha Mainali, Ohio State University

Brief Summary:
Patients >18 years of age presenting to Ohio State Wexner Medical Center Emergency department with stroke symptoms, within 6 hours of last know well and found to have acute anterior circulation large vessel occlusion (LVO) will be included in this study. The purpose of this study is to evaluate the differential expression of exosomal microRNAs in patients with stroke due to acute LVO as compared to healthy controls. In addition, the investigators will also evaluate the differential expression of exosomal microRNA in patients with good vs poor collateral grade.

Condition or disease Intervention/treatment
Cerebrovascular Disorders Genetic: miRNA sampling

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Study Type : Observational
Estimated Enrollment : 45 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Identification of microRNAs Involved in Cerebral Collateral Regulation
Actual Study Start Date : August 14, 2018
Estimated Primary Completion Date : August 14, 2019
Estimated Study Completion Date : August 20, 2020

Group/Cohort Intervention/treatment
Control
A total of 15 healthy controls will be enrolled and miRNA samples will be collected
Genetic: miRNA sampling
Blood samples for miRNA testing will be collected from all subjects (control and patients diagnosed with acute ischemic stroke)

Stroke
A total of 30 acute stroke patients with large vessel occlusions will be enrolled.
Genetic: miRNA sampling
Blood samples for miRNA testing will be collected from all subjects (control and patients diagnosed with acute ischemic stroke)




Primary Outcome Measures :
  1. identification of differentially expressed microRNAs in patients with sudden acute anterior circulation large vessel occlusion, compared to healthy controls. [ Time Frame: 2 years ]
    The investigators will identify and report the microRNAs differentially expressed in patients with acute large vessel occlusion compared to healthy controls.


Secondary Outcome Measures :
  1. Identification of differentially expressed microRNAs in patients with good vs poor cerebral collateral circulation [ Time Frame: 2 years ]
    differential expression of microRNAs in participants with good and poor collateral circulation will be assessed and reported


Biospecimen Retention:   Samples Without DNA
microRNA sampling


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients aged >18 years presenting to the Emergency Department at Ohio State Wexner Medical Center with acute ischemic stroke within 6 hours of last known well will be screened. The investigators will include patients with acute anterior circulation LVO as identified by CT Angiogram. Healthy subjects will be used as controls to assess differentially expressed miRNAs specific to stroke population.
Criteria

Inclusion criteria:

  1. Age 18 years or older.
  2. Diagnosis of Acute Ischemic Stroke secondary to LVO
  3. LVO from presumed embolic source (<50% ICA)
  4. CT perfusion/RAPID images showing salvageable penumbra (evaluated by PI)

Exclusion:

  1. >50% stenosis of internal carotid artery
  2. >50% stenosis of bilateral vertebral arteries.
  3. Patients with moderate to severe intracranial atherosclerotic disease as seen in CTA of head and neck.
  4. Known moderate to severe PVD or symptomatic CAD
  5. Past medical history of stent or coronary artery bypass surgery
  6. Prisoners
  7. Pregnant women
  8. Previous stroke within 30 days
  9. Intracranial vascular malformation or evidence of moya-moya disease
  10. Serious advanced or terminal illness per judgment of the investigator with life expectancy <1yr
  11. Known allergy to iodine that precludes CTA or CTP studies
  12. Presumed septic embolus or suspected bacterial endocarditis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03905434


Contacts
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Contact: Mohammad M Hamed 614-688-6681 mohammad.hamed@osumc.edu
Contact: Luke Herren 614-366-6703 luke.herren@osumc.edu

Locations
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United States, Ohio
The Ohio State University Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Mohammad M Hamed    614-668-6681    mohammad.hamed@osumc.edu   
Principal Investigator: Shraddha Mainali, MD         
Sponsors and Collaborators
Ohio State University
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Responsible Party: Shraddha Mainali, Assistant Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT03905434    
Other Study ID Numbers: 2018H0199
First Posted: April 5, 2019    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shraddha Mainali, Ohio State University:
Large vessel occlusion
Acute ischemic stroke
microRNA
Additional relevant MeSH terms:
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Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases