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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06277895
Other study ID # KYLL-202401-047
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 26, 2024
Est. completion date December 31, 2024

Study information

Verified date January 2024
Source Qilu Hospital of Shandong University
Contact Yuan Bian, Dr.
Phone +8618560083065
Email bianyuan@sdu.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this observation study is to compare VOCs in cardiogenic chest pain population/health conditions, to answer:Establishment and promotion of the application system of emergency rapid detection of expiratory Volatile Organic Compounds (VOCs) in patients with acute cardiogenic chest pain 1. VOCs levels were measured at baseline in healthy people, and markers of VOCs that could be used to identify acute cardiogenic chest pain were sought. 2. The relationship between abnormal VOCs (mainly aldehydes) and prognosis of patients and the correlation with Super-score for early warning of acute heart failure.


Recruitment information / eligibility

Status Recruiting
Enrollment 1400
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: Observation group inclusion criteria: 1. Over 18 years old, male or female; 2. Patients with acute cardiogenic chest pain (see diagnostic criteria); 3. Patient's informed consent. Inclusion criteria of healthy control group: 1. Over 18 years old, male or female; 2. Centerless cerebrovascular disease, lung disease, no abnormal liver and kidney function, no acute infection recently; 3. Informed consent. Exclusion Criteria: 1. The patient had difficulty in collecting breath; 2. Patients with terminal illness or receiving palliative care; 3. Have participated in other clinical studies or consider it inappropriate to participate in this study.

Study Design


Intervention

Diagnostic Test:
VOCs
test the end-expiratory gas

Locations

Country Name City State
China Qilu hospital Jinan Shandong

Sponsors (1)

Lead Sponsor Collaborator
Qilu Hospital of Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Baseline VOCs (aldehydes) levels in healthy population Baseline VOCs (aldehydes) levels in healthy population Baseline
Secondary MACE in patients with cardiogenic chest pain the relationship between the different VOCs levels and 30-day MACE in patients with cardiogenic chest pain From enrollment to the end of treatment at 30 days
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