Acute Coronary SyndromeNCT06277895
VOCs in Patients With Acute Cardiogenic Chest Pain
A study testing VOCs in people with Acute Coronary Syndrome and Acute Aortic Syndrome, run by Qilu Hospital of Shandong University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Coronary Syndrome, Acute Aortic Syndrome
- What is being tested?
- VOCs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,400 participants
- Where
- 1 siteChina
- Study dates
- 26 Jan 2024to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Observation group inclusion criteria:
- Over 18 years old, male or female;
- Patients with acute cardiogenic chest pain (see diagnostic criteria);
- Patient\'s informed consent.
- Over 18 years old, male or female;
- Centerless cerebrovascular disease, lung disease, no abnormal liver and kidney function, no acute infection recently;
- Informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Qilu hospital
Jinan, Shandong, 250012
yuan bian, 18560084775, 15165110975@163.com
About this study
Official title: 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.
- Conditions
- Acute Coronary Syndrome, Acute Aortic Syndrome
- Being tested
- VOCs
- Medical subject headings
- Acute Coronary Syndrome, Acute Aortic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VOCsDiagnostic test
test the end-expiratory gas
| Study group | Role | What they receive |
|---|---|---|
| cardiogenic chest pain group | Experimental | cardiogenic chest pain group/acute coronary syndrome Receives: Diagnostic Test: VOCs |
| normal group | Other | Healthy population Receives: Diagnostic Test: VOCs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline VOCs (aldehydes) levels in healthy population
Baseline VOCs (aldehydes) levels in healthy population
Measured: Baseline
Secondary outcomes (1)
MACE in patients with cardiogenic chest pain
the relationship between the different VOCs levels and 30-day MACE in patients with cardiogenic chest pain
Measured: From enrollment to the end of treatment at 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start26 Jan 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06277895
- Sponsor's protocol ID
- KYLL-202401-047
- Status last verified
- Jan 2024
- First submitted
- 25 Jan 2024
- Last updated
- 26 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Emergency Rapid Detection of Expiratory Volatile Organic Compounds (VOCs) in Patients With Acute Cardiogenic Chest Pain
- ClinicalTrials.gov ID
- NCT06277895
- Acronym / sponsor ID
- KYLL-202401-047
- Conditions
- Acute Coronary Syndrome, Acute Aortic Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,400 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 26 Jan 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 26 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cardiogenic chest pain group | Experimental | Diagnostic Test: VOCscardiogenic chest pain group/acute coronary syndrome |
| normal group | Other | Diagnostic Test: VOCsHealthy population |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Over 18 years old, male or female;
- Patients with acute cardiogenic chest pain (see diagnostic criteria);
- Patient\'s informed consent.
- Over 18 years old, male or female;
- Centerless cerebrovascular disease, lung disease, no abnormal liver and kidney function, no acute infection recently;
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VOCstest the end-expiratory gas | Diagnostic test | cardiogenic chest pain group, normal group |
Primary outcome
Baseline VOCs (aldehydes) levels in healthy population
Time frame: Baseline
Baseline VOCs (aldehydes) levels in healthy population
1 secondary outcome
MACE in patients with cardiogenic chest pain
Time frame: From enrollment to the end of treatment at 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
Related trials for Acute Coronary Syndrome
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Recruiting
AI-Assisted Interpretation of Cardiac CT in the Emergency Department
Chest Pain, Acute Coronary Syndrome
Enrolling by invitation
Optical Coherence Tomography in Acute Vessel Evaluation
Ischemic Heart Disease, Ischemic Coronary Artery Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VOCs in people with Acute Coronary Syndrome and Acute Aortic Syndrome, run by Qilu Hospital of Shandong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuan Bian, Dr. (+8618560083065, bianyuan@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline VOCs (aldehydes) levels in healthy population (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2024.