NCT07056491|Not Yet Recruiting
REST4-AAA Registry
REST4 Registry
Serum REST4 as a Predictive Biomarker for Abdominal Aortic Aneurysm Progression
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REST4 Registry
Serum REST4 as a Predictive Biomarker for Abdominal Aortic Aneurysm Progression
Sponsor study identifier
observational
70
1 country
1
Study Start
July 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
July 1, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
July 1, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 1, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 19, 2025
Actual (reported)July 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
July 9, 2025
Actual (reported)July 1, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
July 1, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
Rates of AAA repair/rupture
5 years
Mortality
5 years
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.
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Patients With an Abdominal Aortic Aneurysm of 39-49 mm in Diameter.
Ren Ji Hospital Afflited to School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, China
This study need to retain processed serum samples from participants to isolate exosome and quantify the REST4 mRNA level.
First Submitted
June 19, 2025
First Posted
July 9, 2025
Study Start
July 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
July 1, 2031
EstimatedThe Effect of Abdominal Aortic Aneurysm Screening on Mortality in Asian Population
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Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
July 1, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
July 9, 2025
Record last verified: 2025-06
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Source: ClinicalTrials.gov.
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