Accuracy Assessment of a Novel Gas Detection Approach in Dyslipidemia Diagnosis

NCT06486857 | Not Yet Recruiting

• 1 other identifier: KS2024055
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to validate the feasibility and accuracy of a novel gas detection method for dyslipidemia screening by analyzing the lipid profile of human breath metabolites. It explores a simple, rapid, and non-invasive method for screening dyslipidemia. The application prospects of this method are broad; it can be used not only for early screening and monitoring of dyslipidemia in hospitals and communities, providing strong support for the prevention of cardiovascular diseases, but also for the routine monitoring and treatment effectiveness evaluation of patients with hyperlipidemia, offering a scientific basis for personalized treatment plans. This study not only has profound scientific value but also provides a theoretical basis for the development of subsequent new clinical testing methods.

Conditions

Dyslipidemias; Gas Detection Method

Outcome Measures

Primary Outcomes (1)

• accuracy of cholesterol testing

  within 1 week day of sample collection

Interventions

a novel gas detection method for dyslipidemia screening DIAGNOSTIC_TEST

Multidimensional Mass Spectrometry Technologies Based on Exhaled Metabolic Fingerprint Spectra for Dyslipidemia Detection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

healthy volunteer

You may qualify if:

• Age ≥ 18 years
• Voluntarily signed the informed consent form

You may not qualify if:

• Patients with lung cancer, asthma, chronic obstructive pulmonary disease, pulmonary cystic fibrosis, or acute respiratory distress syndrome
• Women who are pregnant or breastfeeding
• Patients with chronic kidney disease (GFR \< 60 ml/min) or cirrhosis
• Individuals unable to cooperate with the collection of exhaled gas samples

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead

Study Sites (1)

Beijing Anzhen hospital

Beijing, Beijing Municipality, 100029, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

exhaled breath condensate

MeSH Terms

Conditions

Dyslipidemias

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2024
• First Posted: July 5, 2024
• Study Start: July 1, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 30, 2026
• Last Updated: July 5, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)