AtherosclerosisNCT01928095
RNA Cloning and Visualization in Human Atherosclerosis
An observational study of Atherosclerosis, run by University of Virginia at 1 site in United States.
Trial summary
The research objectives of this project are as follows: 1. Obtain high-quality human atherosclerotic arterial samples from diseased donors. 2. Perform biochemical analysis to determine the abundance, localization and activity of Dicer and double-stranded RNAs in these diseased tissues. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atherosclerosis
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Nov 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Male and Female patients undergoing carotid endarterectomy
Who may be able to join
- Age of 18 and older
- Undergoing carotid endarterectomy
Who cannot join
- Under 18 years of age
- Not undergoing carotid endarterectomy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kentucky Chandler Medical Center
Lexington, Kentucky, 40536
About this study
The research objectives of this project are as follows:
- Obtain high-quality human atherosclerotic arterial samples from diseased donors.
- Perform biochemical analysis to determine the abundance, localization and activity of Dicer and double-stranded RNAs in these diseased tissues.
Read the detailed description
Participants enrolled in to this pilot study will not be randomized and will not receive any investigation medication.
In collaboration with Dr. Sibu Saha, Professor of Surgery, University of Kentucky, the investigator will obtain freshly isolated human atherosclerotic tissue from patients undergoing carotid endarterectomy. The surgical process by which the tissue is obtained is not part of this research project. These tissues are surgically removed from patients as a treatment for atherosclerosis of the carotid arteries and typically sent for pathological examination.
After the the clinical pathology has been completed, the investigator will obtain and analyze a small amount of discarded (200mg) tissue. Subsequent analyses will be performed on the basis of the pathological grading provided by UK Pathology (e.g do readouts of the Dicer pathway correlate with pathological plaque characteristics). Tissue will be anonymized, with only information with respect to drug history, age, gender and pathological grade of the tissue.
The will extract protein and RNA. Dicer abundance will be assessed by western blot, quantitative RT-PCR and northern blot. Dicer related RNAs will be measured by quantitative RT-PCR and northern blot. The invesigator will inspect the tissue for evidence of altered Dicer activity by measuring the relative levels of abundant canonical Dicer substrates/enzymatic products (i.e. the ratio of pre- to mature micro-RNA) via northern blot. The investigator predicts that Dicer levels and activity are reduced in human atherosclerotic tissue compared to healthy arteries.
Next, the investigator will assess whether downstream mediators of Dicer dysregulation are activated in these tissue samples by comparing levels and activation of the inflammasome (caspase-1, NLRP3, ASC), cytokines (IL-1β, IL-18) and signaling intermediates (MyD88, IRAK1/4) between healthy and diseased tissues. The investigator predicts that atherosclerotic plaques will exhibit evidence of Dicer dysregulation.
Next, the investigator will co-stain tissue sections with antibodies recognizing Dicer as well as cell-specific markers (CD31 for endothelium, SMA for smooth muscle, MAC-1 for macrophages) to assess whether Dicer dysregulation displays cell type-specific patterns.
- Conditions
- Atherosclerosis
- Keywords
- atherosclerosis, carotid endartherectomy
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Carotid Endocardectomy Patients | Subsequent analyses will be performed on the basis of the pathological grading provided by UK Pathology (e.g do readouts of the Dicer pathway correlate with pathological plaque characteristics). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Altered Dicer Activity
The investigator will measure the relative levels of abundant canonical Dicer substrates/enzymatic products (i.e. the ratio of pre- to mature micro-RNA) via northern blot
Measured: 1 year
Secondary outcomes (1)
Are downstream mediators of Dicer dysregulation activated
Analysis will compare levels and activation of the inflammasome (caspase-1, NLRP3, ASC), cytokines (IL-1β, IL-18) and signaling intermediates (MyD88, IRAK1/4) between healthy and diseased tissues.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2013 (estimated)
- Study startOct 2013
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bradley Gelfand, PhD, University of Virginia
- Investigators
- Bradley Gelfand, PhD, Principal investigator, University of Virginia, Department of OphthalmologyBradley Gelfand, PhD, Principal investigator, Ophthalmology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01928095
- Sponsor's protocol ID
- IRB # 13-0623-F1V
- Status last verified
- Apr 2017
- First submitted
- 20 Aug 2013
- Last updated
- 13 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RNA Cloning and Visualization in Human Atherosclerosis
- ClinicalTrials.gov ID
- NCT01928095
- Acronym / sponsor ID
- IRB # 13-0623-F1V
- Conditions
- Atherosclerosis
- Keywords
- atherosclerosis, carotid endartherectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 23 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The research objectives of this project are as follows:
- Obtain high-quality human atherosclerotic arterial samples from diseased donors.
- Perform biochemical analysis to determine the abundance, localization and activity of Dicer and double-stranded RNAs in these diseased tissues.
Detailed description
Participants enrolled in to this pilot study will not be randomized and will not receive any investigation medication.
In collaboration with Dr. Sibu Saha, Professor of Surgery, University of Kentucky, the investigator will obtain freshly isolated human atherosclerotic tissue from patients undergoing carotid endarterectomy. The surgical process by which the tissue is obtained is not part of this research project. These tissues are surgically removed from patients as a treatment for atherosclerosis of the carotid arteries and typically sent for pathological examination.
After the the clinical pathology has been completed, the investigator will obtain and analyze a small amount of discarded (200mg) tissue. Subsequent analyses will be performed on the basis of the pathological grading provided by UK Pathology (e.g do readouts of the Dicer pathway correlate with pathological plaque characteristics). Tissue will be anonymized, with only information with respect to drug history, age, gender and pathological grade of the tissue.
The will extract protein and RNA. Dicer abundance will be assessed by western blot, quantitative RT-PCR and northern blot. Dicer related RNAs will be measured by quantitative RT-PCR and northern blot. The invesigator will inspect the tissue for evidence of altered Dicer activity by measuring the relative levels of abundant canonical Dicer substrates/enzymatic products (i.e. the ratio of pre- to mature micro-RNA) via northern blot. The investigator predicts that Dicer levels and activity are reduced in human atherosclerotic tissue compared to healthy arteries.
Next, the investigator will assess whether downstream mediators of Dicer dysregulation are activated in these tissue samples by comparing levels and activation of the inflammasome (caspase-1, NLRP3, ASC), cytokines (IL-1β, IL-18) and signaling intermediates (MyD88, IRAK1/4) between healthy and diseased tissues. The investigator predicts that atherosclerotic plaques will exhibit evidence of Dicer dysregulation.
Next, the investigator will co-stain tissue sections with antibodies recognizing Dicer as well as cell-specific markers (CD31 for endothelium, SMA for smooth muscle, MAC-1 for macrophages) to assess whether Dicer dysregulation displays cell type-specific patterns.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Carotid Endocardectomy Patients | – | –Subsequent analyses will be performed on the basis of the pathological grading provided by UK Pathology (e.g do readouts of the Dicer pathway correlate with pathological plaque characteristics). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male and Female patients undergoing carotid endarterectomy
Key inclusion criteria (2 listed)
- Age of 18 and older
- Undergoing carotid endarterectomy
Key exclusion criteria (2 listed)
- Under 18 years of age
- Not undergoing carotid endarterectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Altered Dicer Activity
Time frame: 1 year
The investigator will measure the relative levels of abundant canonical Dicer substrates/enzymatic products (i.e. the ratio of pre- to mature micro-RNA) via northern blot
1 secondary outcome
Are downstream mediators of Dicer dysregulation activated
Time frame: 1 Year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bradley Gelfand, PhD principal investigator
University of Virginia, Department of Ophthalmology
Bradley Gelfand, PhD principal investigator
Ophthalmology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atherosclerosis, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Altered Dicer Activity (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2017.