NCT06277895

Brief 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. 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

January 26, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 26, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

February 26, 2024

Status Verified

January 1, 2024

Enrollment Period

11 months

First QC Date

January 25, 2024

Last Update Submit

February 18, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Baseline VOCs (aldehydes) levels in healthy population

    Baseline VOCs (aldehydes) levels in healthy population

    Baseline

Secondary Outcomes (1)

  • MACE in patients with cardiogenic chest pain

    From enrollment to the end of treatment at 30 days

Study Arms (2)

cardiogenic chest pain group

EXPERIMENTAL

cardiogenic chest pain group/acute coronary syndrome

Diagnostic Test: VOCs

normal group

OTHER

Healthy population

Diagnostic Test: VOCs

Interventions

VOCsDIAGNOSTIC_TEST

test the end-expiratory gas

cardiogenic chest pain groupnormal group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qilu hospital

Jinan, Shandong, 250012, China

RECRUITING

MeSH Terms

Conditions

Acute Coronary SyndromeAcute Aortic Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesAortic Diseases

Central Study Contacts

Xiuting Yang, Dr.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2024

First Posted

February 26, 2024

Study Start

January 26, 2024

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

February 26, 2024

Record last verified: 2024-01

Locations