Accuracy Assessment of a Novel Gas Detection Approach in Dyslipidemia Diagnosis

June 27, 2024 updated by: Beijing Anzhen Hospital

Accuracy Validation Study of a Novel Gas Detection Method for Dyslipidemia

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100029
        • Beijing Anzhen Hospital
        • Contact:
          • Zeqi Dai, PhD
        • Principal Investigator:
          • Yan Yan, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

healthy volunteer

Description

Inclusion Criteria:

  1. Age ≥ 18 years
  2. Voluntarily signed the informed consent form

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
accuracy of cholesterol testing
Time Frame: within 1 week day of sample collection
within 1 week day of sample collection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Anzhen Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2024

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

June 27, 2024

First Submitted That Met QC Criteria

June 27, 2024

First Posted (Actual)

July 5, 2024

Study Record Updates

Last Update Posted (Actual)

July 5, 2024

Last Update Submitted That Met QC Criteria

June 27, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KS2024055

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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