Abdominal Aortic AneurysmREST4 RegistryNCT07056491
REST4-AAA Registry
An observational study of Abdominal Aortic Aneurysm, run by RenJi Hospital at 1 site in China.
Trial summary
This prospective observational study aims to investigate whether serum REST4 concentration can serve as a quantitative indicator correlated with abdominal aortic aneurysm (AAA) diameter and a predictive biomarker for AAA progression and rupture risk. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysm
- What is being tested?
- mRNA level of REST4 in serum;
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2025to 1 Jul 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients With an Abdominal Aortic Aneurysm of 39-49 mm in Diameter.
Who may be able to join
- Presence of an infrarenal AAA with a maximum diameter of 39-49 mm;
- Han nationality;
- Between 50 years or more, no gender limit;
- No mental illness;
- Subjects voluntarily participate in this study, sign an informed consent form, have good compliance, and cooperate with follow-up.
Who cannot join
- Previous infrarenal aortic surgery;
- Planned major surgery;
- Known aortic dissection;
- Have received any other clinical trial treatment within 1 year;
- Systemic treatment with corticosteroids or other systemic immunomodulatory therapy;
- Severe infections, including but not limited to infections requiring hospitalization, bacteremia, severe pneumonia, etc.;
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- Known or suspected inherited connective tissue disorder;
- Known or suspected prostate cancer;
- Calculated creatinine clearance of less than 30 ml/min;
- Known significant liver disease;
- Known human immunodeficiency virus infection at the time of screening；
- Serious concomitant illness associated with life expectancy of less than 2 years；
- Any other significant and unstable condition that could limit compliance with the trial protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Ren Ji Hospital Afflited to School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality
Jun Pu, MD,PhD, 86-21-68383477, pujun310@hotmail.com
About this study
Official title: Serum REST4 as a Predictive Biomarker for Abdominal Aortic Aneurysm Progression
This prospective observational study aims to investigate whether serum REST4 concentration can serve as a quantitative indicator correlated with abdominal aortic aneurysm (AAA) diameter and a predictive biomarker for AAA progression and rupture risk. Emerging evidence suggests that REST4, a splice variant of the RE-1 Silencing Transcription Factor (REST), is upregulated in vascular smooth muscle cells during AAA pathogenesis and may be released into circulation via exosomes. The study will enroll patients with asymptomatic AAA (diameter between 39-49 mm) and measure baseline serum REST4 levels, analyzing their association with morphological severity (maximum aortic diameter) and clinical outcomes (aneurysm growth rate, rupture and related mortality) through a 5-year follow-up period.
Read the detailed description
Abdominal aortic aneurysm (AAA) is a life-threatening vascular disease characterized by progressive dilation of the abdominal aorta, ultimately leading to catastrophic rupture with high mortality. Currently, clinical management relies mainly on aneurysm diameter for risk assessment, lacking reliable biomarkers to predict disease progression or rupture risk. Emerging evidence highlights the critical role of vascular smooth muscle cell (VSMC) phenotypic switching in AAA pathogenesis. Preliminary research has identified that RE-1 Silencing Transcription Factor (REST) in VSMC undergoes alternative splicing in AAA tissues, resulting in predominant expression of its splice variant REST4 and downregulation of full-length REST. This molecular shift triggers STAT1 activation, promoting synthetic VSMC transformation.
The study hypothesizes that synthetic VSMC in AAA lesions secrete REST4 into circulation via exosomes, making serum REST4 a potential dual-parameter biomarker that quantitatively correlates with aneurysm diameter (morphological severity) and predicts disease progression and rupture risk.
This prospective observational study will systematically evaluate asymptomatic AAA patients (39-49 mm diameter) to first determine the relationship between serum REST4 levels and maximum aortic diameter. Subsequently, through 5-year follow-up, the investigators will assess the prognostic capacity of serum REST4 concentration for predicting annual aneurysm growth rates, rupture incidence, and aneurysm-specific mortality.
Validation of correlation between serum REST4 concentration and AAA progression could transform current AAA surveillance approaches by integrating molecular profiling with traditional anatomical monitoring, enabling more precise risk stratification and personalized clinical management to ultimately improve patient outcomes.
- Conditions
- Abdominal Aortic Aneurysm
- Being tested
- mRNA level of REST4 in serum;
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mRNA level of REST4 in serum;Other
- mRNA level of REST4 in serum The mRNA expression level of REST4 was measured in serum-derived exosomes using RT-qPCR at the time of patient enrollment.
- Computed tomography angiography (CTA) Baseline maximum internal diameter of the abdominal aortic aneurysm (AAA) was determined by CTA at enrollment. During follow-up, CTA was performed to assess the increase in maximum AAA diameter.
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum REST4 Level
Quantification of serum REST4 mRNA levels in enrolled patients using RT-qPCR method
Measured: Baseline
Maximal diameter of abdominal aorta
Measurement of maximal diameter of infrarenal abdominal aorta from leading edge adventitia at the anterior wall to leading edge adventitia at the posterior wall by computed tomography angiography
Measured: Baseline
Change in abdominal aortic diameter
Measurement of maximal diameter of infrarenal abdominal aorta from leading edge adventitia at the anterior wall to leading edge adventitia at the posterior wall by computed tomography angiography during 5-year follow-up period.
Measured: 5 years
Secondary outcomes (2)
Rates of AAA repair/rupture
Calculate the incidence of AAA repair/rupture
Measured: 5 years
Mortality
Calculate the mortality due to AAA rupture
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2025
- Study start1 Jul 2025 (estimated)
- Primary completion1 Jul 2031 (estimated)
- Study completion1 Jul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Aortic AneurysmStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07056491
- Sponsor's protocol ID
- REST4-AAA
- Acronym
- REST4 Registry
- Status last verified
- Jun 2025
- First submitted
- 19 Jun 2025
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum REST4 as a Predictive Biomarker for Abdominal Aortic Aneurysm Progression
- ClinicalTrials.gov ID
- NCT07056491
- Acronym / sponsor ID
- REST4 Registry / REST4-AAA
- Conditions
- Abdominal Aortic Aneurysm
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 1 Jul 2031 (estimated)
- Study completion
- 1 Jul 2031 (estimated)
- First posted
- 9 Jul 2025 (actual)
- 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.
This prospective observational study aims to investigate whether serum REST4 concentration can serve as a quantitative indicator correlated with abdominal aortic aneurysm (AAA) diameter and a predictive biomarker for AAA progression and rupture risk. Emerging evidence suggests that REST4, a splice variant of the RE-1 Silencing Transcription Factor (REST), is upregulated in vascular smooth muscle cells during AAA pathogenesis and may be released into circulation via exosomes. The study will enroll patients with asymptomatic AAA (diameter between 39-49 mm) and measure baseline serum REST4 levels, analyzing their association with morphological severity (maximum aortic diameter) and clinical outcomes (aneurysm growth rate, rupture and related mortality) through a 5-year follow-up period.
Detailed description
Abdominal aortic aneurysm (AAA) is a life-threatening vascular disease characterized by progressive dilation of the abdominal aorta, ultimately leading to catastrophic rupture with high mortality. Currently, clinical management relies mainly on aneurysm diameter for risk assessment, lacking reliable biomarkers to predict disease progression or rupture risk. Emerging evidence highlights the critical role of vascular smooth muscle cell (VSMC) phenotypic switching in AAA pathogenesis. Preliminary research has identified that RE-1 Silencing Transcription Factor (REST) in VSMC undergoes alternative splicing in AAA tissues, resulting in predominant expression of its splice variant REST4 and downregulation of full-length REST. This molecular shift triggers STAT1 activation, promoting synthetic VSMC transformation.
The study hypothesizes that synthetic VSMC in AAA lesions secrete REST4 into circulation via exosomes, making serum REST4 a potential dual-parameter biomarker that quantitatively correlates with aneurysm diameter (morphological severity) and predicts disease progression and rupture risk.
This prospective observational study will systematically evaluate asymptomatic AAA patients (39-49 mm diameter) to first determine the relationship between serum REST4 levels and maximum aortic diameter. Subsequently, through 5-year follow-up, the investigators will assess the prognostic capacity of serum REST4 concentration for predicting annual aneurysm growth rates, rupture incidence, and aneurysm-specific mortality.
Validation of correlation between serum REST4 concentration and AAA progression could transform current AAA surveillance approaches by integrating molecular profiling with traditional anatomical monitoring, enabling more precise risk stratification and personalized clinical management to ultimately improve patient outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients With an Abdominal Aortic Aneurysm of 39-49 mm in Diameter.
Key inclusion criteria (5 listed)
- Presence of an infrarenal AAA with a maximum diameter of 39-49 mm;
- Han nationality;
- Between 50 years or more, no gender limit;
- No mental illness;
- Subjects voluntarily participate in this study, sign an informed consent form, have good compliance, and cooperate with follow-up.
Key exclusion criteria (13 listed)
- Previous infrarenal aortic surgery;
- Planned major surgery;
- Known aortic dissection;
- Have received any other clinical trial treatment within 1 year;
- Systemic treatment with corticosteroids or other systemic immunomodulatory therapy;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mRNA level of REST4 in serum;1. mRNA level of REST4 in serum The mRNA expression level of REST4 was measured in serum-derived exosomes using RT-qPCR at the time of patient enrollment. 2. Computed tomography angiography (CTA) Baseline maximum internal diameter of the abdominal aortic aneurysm (AAA) was determined by CTA at enrollment. During follow-up, CTA was performed to assess the increase in maximum AAA diameter. | Other | – |
Primary outcome
Serum REST4 Level
Time frame: Baseline
Quantification of serum REST4 mRNA levels in enrolled patients using RT-qPCR method
Maximal diameter of abdominal aorta
Time frame: Baseline
Measurement of maximal diameter of infrarenal abdominal aorta from leading edge adventitia at the anterior wall to leading edge adventitia at the posterior wall by computed tomography angiography
Change in abdominal aortic diameter
Time frame: 5 years
Measurement of maximal diameter of infrarenal abdominal aorta from leading edge adventitia at the anterior wall to leading edge adventitia at the posterior wall by computed tomography angiography during 5-year follow-up period.
2 secondary outcomes
Rates of AAA repair/rupture
Time frame: 5 years
Mortality
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
- Individual participant dataSharing planned: Undecided
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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.
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 Abdominal Aortic Aneurysm, run by RenJi Hospital at 1 site in China.
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 5 inclusion and 13 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: opening soon, as of the sponsor's last update on 9 Jul 2025. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jun Pu, MD,PhD (86-21-68383477, pujun310@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum REST4 Level (time frame: Baseline). The study lists 3 primary outcomes in all. 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 9 Jul 2025.