Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04586452 · ClinicalTrials.gov registry record · Early Phase 1
NIH CCR2 AAA Study
A Early Phase 1 study of Abdominal Aortic Aneurysm (AAA) and No Abdominal Aortic Aneurysm (Non-AAA), sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT04586452: Completed Early Phase 1 study of Abdominal Aortic Aneurysm (AAA) and No Abdominal Aortic Aneurysm (Non-AAA), sponsored by Washington University School of Medicine.
NCT04586452 is a Early Phase 1 study of Abdominal Aortic Aneurysm (AAA) and No Abdominal Aortic Aneurysm (Non-AAA) that has completed, run by Washington University School of Medicine. The registered enrollment target is 50 participants, below the 172-participant average among 3 other Abdominal Aortic Aneurysm (AAA) trials with a reported enrollment target (71% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04586452, a Early Phase 1 study of Abdominal Aortic Aneurysm (AAA) and No Abdominal Aortic Aneurysm (Non-AAA), has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
Abdominal aortic aneurysm (AAA) is a degenerative vascular disease, which is typically asymptomatic until rupture, resulting in high mortality. AAAs are more prevalent in men over age 65, though rupture is disproportionately higher in women. Due to nonlinear and unpredictable aortic dilatation, it is challenging to predict the AAA rupture using clinical diagnostics based on morphology. No medical therapy is used clinically to treat AAA, and there is an unmet need for clinically translatable, molecular biomarkers of AAA disease activity for surveillance and patient-specific management. The goal of this proposal is to develop a new approach for the diagnosis and targeted therapy of AAA.
Primary Outcome
Perform histopathological evaluation of human AAA specimens and categorize them based on clinical status (e.g, diameter) and degree of inflammation. The investigators will consider healthy, nonatherosclerotic aorta as negative controls, and non-aneurysmal aortas from patients that have undergone surgery for aortoiliac occlusive disease as positive controls. Disease severity will be graded as mild, moderate, and severe based on the degree of VSMC loss and elastic layer disruption (\<25%, 25-75%,
Conditions Studied
Interventions
- DIAGNOSTIC_TEST AAA Group (Aim 3A)
- DIAGNOSTIC_TEST Non-AAA Group
- OTHER Ex Vivo Human AAA Specimens (Aim 2A)
- OTHER Relationship between radiotracer and CCR2 (Aim 2B)
- DIAGNOSTIC_TEST AAA Group (Aim 3B-Reproducibility)
Study Locations (1)
Missouri
- Washington University School of Medicine - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2021-02-17 |
| Est. Completion | 2022-04-04 |
| Phase | Early Phase 1 |
What the finished NCT04586452 record still lists
NCT04586452 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 172-participant average among 3 other Abdominal Aortic Aneurysm (AAA) trials with a reported enrollment target (71% lower).
The record links to 2 conditions, with Abdominal Aortic Aneurysm (AAA) appearing as the primary indexed condition, and to 5 interventions - of which AAA Group (Aim 3A) is the first listed.
NCT04586452 reports a single indexed study location in Missouri.
Frequently Asked Questions
What is clinical trial NCT04586452 about?
NCT04586452 is a clinical study titled "NIH CCR2 AAA Study". Abdominal aortic aneurysm (AAA) is a degenerative vascular disease, which is typically asymptomatic until rupture, resulting in high mortality. AAAs are more prevalent in men over age 65, though rupture is disproportionately higher in women. Due to nonlinear and unpredictable aortic dilatation, it i...
What is the current status of trial NCT04586452?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 50 participants. The study started on 2021-02-17. Estimated completion is 2022-04-04.
What conditions does trial NCT04586452 study?
This clinical trial studies the following conditions: Abdominal Aortic Aneurysm (AAA), No Abdominal Aortic Aneurysm (Non-AAA).
What interventions are being tested in trial NCT04586452?
The interventions under investigation include: AAA Group (Aim 3A) (DIAGNOSTIC_TEST), Non-AAA Group (DIAGNOSTIC_TEST), Ex Vivo Human AAA Specimens (Aim 2A) (OTHER), Relationship between radiotracer and CCR2 (Aim 2B) (OTHER), AAA Group (Aim 3B-Reproducibility) (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT04586452?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04586452 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Abdominal Aortic Aneurysm (AAA)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Evaluation of the Aortoseal™ for Sealing and Fixation of AAA Endovascular Grafts to Aortic Wall
RECRUITING · NA
-
Clinical Study of the Treovance Stent-Graft for Patients With Abdominal Aortic Aneurysms
ACTIVE NOT RECRUITING · NA
-
Safety and Effectiveness Study of Endovascular Abdominal Aortic Aneurysm Repair Using the Nellix® System
COMPLETED · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00200889 · 50 participants · Early Phase 1
Mapping Auricular Vagus Nerve Circuitry
- NCT00409435 · 50 participants · Phase 2
A Study of Pyridostigmine in Postural Tachycardia Syndrome
- NCT01202305 · 50 participants
The Use of Lymph Node Biopsies to Support HIV Pathogenesis Studies
- NCT01225913 · 50 participants · Phase 4
Mechanism(s) of Airflow Limitation During Exacerbation of Asthma
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI