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Objective Vascular Biomarkers as Triage for Depression in Chronic Atrophic Gastritis

NCT07319338 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 520

Last updated 2026-01-06

No results posted yet for this study

Summary

Depressive symptoms are highly prevalent in patients with chronic atrophic gastritis (CAG) but are frequently under-detected due to stigma and reliance on subjective questionnaires. This multicenter, cross-sectional observational study aims to validate a novel clinical triage workflow. It repurposes routine vascular assessments (specifically dorsalis pedis artery ultrasound and arterial stiffness metrics) as objective "biological entry points" to facilitate mental health referrals. The study will enroll approximately 450-520 adults with histologically confirmed CAG across four clinical centers in China. The primary objective is to determine the diagnostic accuracy of these vascular biomarkers for identifying patients with moderate-to-severe depressive symptoms (PHQ-9 score \>= 10). Secondary objectives include evaluating the implementation feasibility (e.g., referral uptake, screening completion rate) of this integrated care model in routine gastroenterology practice.

Conditions

  • Chronic Atrophic Gastritis
  • Depressive Symptoms
  • Depression
  • Gastrointestinal Diseases

Interventions

DIAGNOSTIC_TEST

Vascular-Psychological Triage Workflow

Participants undergo a multimodal assessment including high-frequency ultrasound of the dorsalis pedis artery, measurement of brachial-ankle pulse wave velocity (baPWV), and completion of the PHQ-9 depression screening scale.

Sponsors & Collaborators

  • Beijing Anzhen Hospital

    collaborator OTHER

  • Hengshui Hospital of Traditional Chinese Medicine

    collaborator UNKNOWN

  • Liyang Hospital of Traditional Chinese Medicine

    collaborator UNKNOWN

  • China Academy of Chinese Medical Sciences

    lead OTHER

Eligibility

Min Age
20 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-01
Primary Completion
2026-06-20
Completion
2026-08-30

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07319338 on ClinicalTrials.gov