Objective Vascular Biomarkers as Triage for Depression in Chronic Atrophic Gastritis (NCT07319338) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Objective Vascular Biomarkers as Triage for Depression in Chronic Atrophic Gastritis
China520 participantsStarted 2026-02-01
Plain-language 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.
Who can participate
Age range20 Years – 60 Years
SexALL
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Inclusion criteria
✓. Age between 20 and 60 years, regardless of sex.
✓. Diagnosed with chronic atrophic gastritis (CAG) confirmed by upper gastrointestinal endoscopy and histopathology within the past 6 months.
✓. Ability to comprehend and voluntarily complete psychological assessments and multimodal vascular examinations.
✓. Willingness to provide written informed consent.
Exclusion criteria
✕. History of major psychiatric disorders (e.g., schizophrenia, bipolar disorder) or currently experiencing an acute psychotic episode.
✕. Major cardiovascular or cerebrovascular events (e.g., acute myocardial infarction, stroke) within the past 3 months.
✕. Severe peripheral artery disease or major anatomical abnormalities in the lower extremities (e.g., Fontaine stage III-IV, diabetic foot with ulcers) that would preclude reliable dorsalis pedis artery ultrasound assessment.
✕. Severe hepatic or renal dysfunction, or malignancy with a limited life expectancy.
What they're measuring
1
Depressive Symptom Screening-Positive Status (PHQ-9 ≥10)