- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06277895
VOCs in Patients With Acute Cardiogenic Chest Pain
February 18, 2024 updated by: Qilu Hospital of Shandong University
Application of Emergency Rapid Detection of Expiratory Volatile Organic Compounds (VOCs) in Patients With Acute Cardiogenic Chest Pain
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
- 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.
- The relationship between abnormal VOCs (mainly aldehydes) and prognosis of patients and the correlation with Super-score for early warning of acute heart failure.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
1400
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yuan Bian, Dr.
- Phone Number: +8618560083065
- Email: bianyuan@sdu.edu.cn
Study Contact Backup
- Name: Xiuting Yang, Dr.
- Phone Number: 800-872-5327
- Email: yxt-1819@163.com
Study Locations
-
-
Shandong
-
Jinan, Shandong, China, 250012
- Recruiting
- Qilu hospital
-
Contact:
- yuan bian
- Phone Number: 18560084775
- Email: 15165110975@163.com
-
-
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
Description
Inclusion Criteria:
Observation group inclusion criteria:
- Over 18 years old, male or female;
- Patients with acute cardiogenic chest pain (see diagnostic criteria);
- Patient's informed consent.
Inclusion criteria of healthy control group:
- Over 18 years old, male or female;
- Centerless cerebrovascular disease, lung disease, no abnormal liver and kidney function, no acute infection recently;
- Informed consent.
Exclusion Criteria:
- The patient had difficulty in collecting breath;
- Patients with terminal illness or receiving palliative care;
- Have participated in other clinical studies or consider it inappropriate to participate in this study.
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
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: cardiogenic chest pain group
cardiogenic chest pain group/acute coronary syndrome
|
test the end-expiratory gas
|
Other: normal group
Healthy population
|
test the end-expiratory gas
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Baseline VOCs (aldehydes) levels in healthy population
Time Frame: Baseline
|
Baseline VOCs (aldehydes) levels in healthy population
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
MACE in patients with cardiogenic chest pain
Time Frame: From enrollment to the end of treatment at 30 days
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 (Actual)
January 26, 2024
Primary Completion (Estimated)
December 31, 2024
Study Completion (Estimated)
December 31, 2024
Study Registration Dates
First Submitted
January 25, 2024
First Submitted That Met QC Criteria
February 18, 2024
First Posted (Estimated)
February 26, 2024
Study Record Updates
Last Update Posted (Estimated)
February 26, 2024
Last Update Submitted That Met QC Criteria
February 18, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KYLL-202401-047
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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