REST4-AAA Registry

NCT07056491 | Not Yet Recruiting

• 1 other identifier: REST4-AAA
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Abdominal Aortic Aneurysm

Outcome Measures

Primary Outcomes (3)

• Serum REST4 Level

  Quantification of serum REST4 mRNA levels in enrolled patients using RT-qPCR method

  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

  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.

  5 years

Secondary Outcomes (2)

• Rates of AAA repair/rupture

  5 years

• Mortality

  5 years

Interventions

mRNA level of REST4 in serum; OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients With an Abdominal Aortic Aneurysm of 39-49 mm in Diameter.

You may qualify if:

• 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.

You may not qualify if:

• 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.;
• 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.

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Ren Ji Hospital Afflited to School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

This study need to retain processed serum samples from participants to isolate exosome and quantify the REST4 mRNA level.

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Central Study Contacts

Jun Pu, MD,PhD

CONTACT

86-21-68383477; pujun310@hotmail.com

Yinan Li, MD,PhD

CONTACT

86-21-68383477; liyinan0402@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2025
• First Posted: July 9, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2031
• Study Completion (Estimated): July 1, 2031
• Last Updated: July 9, 2025

Record last verified: 2025-06

Locations

CN (1)