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OR6A2 on Monocytes and Cardiovascular Outcomes in Myocardial Ischemia-Reperfusion Injury

ConditionMyocardial Ischemia-Reperfusion Injury
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorSoutheast University, China

About this trial

This study examines how the interaction between octanal (an OR6A2 receptor activator) and OR6A2 expression influences inflammation and clinical outcomes in Myocardial Ischemia-Reperfusion Injury patients. We analyze two key relationships: 1) The octanal-OR6A2 pathway's association with systemic oxidative stress/inflammatory biomarkers, and 2) How OR6A2 expression patterns on monocyte subtypes and plasma octanal levels correlate with major cardiovascular events. Patients undergoing this post-revascularization injury provided blood samples for OR6A2/octanal/inflammation measurements. IR Injury patients underwent 44-month clinical follow-up. Results may identify biological markers for personalized risk assessment after revascularization therapies. Ethics approval: Zhongda Hospital #2020ZDSYLL051-P01.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Acute myocardial infarction (AMI) patients with angiographically-confirmed coronary artery disease undergoing primary percutaneous coronary intervention (PCI), and subsequently diagnosed with protocol-defined myocardial ischemia-reperfusion injury during the post-PCI period.

Age 18-90 years inclusive.

Disqualifiers

Active systemic infections.

Advanced heart failure (NYHA class III-IV).

Acute cerebrovascular conditions.

Active myocarditis.

Trial population

The study population consists of consecutively enrolled participants with myocardial ischemia-reperfusion injury who are recruited from the Department of Cardiology at Zhongda Hospital, Southeast University, China.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Blood Biomarker Profiling and Prognostic Follow-up

    Diagnostic test

    Peripheral venous blood collection for in-vitro quantification of serum biomarkers (including octanal, OR6A2, and inflammatory mediators) via mass spectrometry/ELISA/flow cytometry, coupled with longitudinal surveillance of Major Adverse Cardiovascular Events (MACEs) using hospital records, patient interviews, and adjudicated endpoint verification during scheduled follow-up visits.

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: Patients With Myocardial Ischemia-Reperfusion Injury1 intervention

Trial outcomes

Primary outcomes

1

Major Adverse Cardiovascular Events

Major Adverse Cardiovascular Events (MACEs) defined as the composite endpoint of recurrent acute myocardial infarction, cardiac death, stroke, hospitalization for unstable angina, or unplanned coronary revascularization.

Time frame
From enrollment to 44 months after reperfusion injury

Secondary outcomes

1

Serum IL-1α Level

Units: pg/mL

Time frame
Baseline (within 24 hours after confirmed myocardial ischemia-reperfusion injury)
2

Serum IL-1β Level

Units: pg/mL

Time frame
Baseline (within 24 hours after confirmed myocardial ischemia-reperfusion injury)
3

Plasma Malondialdehyde (MDA) Level

Units: μmol/L

Time frame
Baseline (within 24 hours after confirmed myocardial ischemia-reperfusion injury)
4

Plasma Hydrogen Peroxide (H₂O₂) Level

Units: μmol/L

Time frame
Baseline (within 24 hours after confirmed myocardial ischemia-reperfusion injury)

Other outcomes

Sponsors and contacts

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Southeast University, China

Lead sponsor

Source ClinicalTrials.gov
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