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

NCT ID: NCT07100457

Last Updated: 2025-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-01

Study Completion Date

2027-08-30

Brief Summary

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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.

Detailed Description

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Conditions

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Myocardial Ischemia-Reperfusion Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients With Myocardial Ischemia-Reperfusion Injury

Blood Biomarker Profiling and Prognostic Follow-up

Intervention Type 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.

Interventions

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Blood Biomarker Profiling and Prognostic Follow-up

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

1. 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.
2. Age 18-90 years inclusive.

Exclusion Criteria

1. Active systemic infections.
2. Advanced heart failure (NYHA class III-IV).
3. Acute cerebrovascular conditions.
4. Active myocarditis.
5. cardiomyopathy.
6. Refractory ventricular tachycardia/fibrillation.
7. Diagnosis/concurrent treatment for malignancy within 5 years (except non-melanoma skin cancer/carcinoma in situ).
8. Severe renal insufficiency (estimated glomerular filtration rate \[eGFR\] \<30 mL/min/1.73m2 or dialysis dependence).
9. Child-Pugh class C hepatic dysfunction.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Southeast University, China

OTHER

Sponsor Role lead

Responsible Party

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Genshan Ma

Director of Cardiovascular Medicine & Deputy Director of Cardiovascular Disease Research Institute, Zhongda Hospital Southeast University; Professor (Level-II); Chief Physician; PhD Advisor; Chairman, Cardiovascular Society of Jiangsu Medical Association

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Cardiology, Zhongda Hospital, Southeast University

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wenbin Lu, PhD

Role: CONTACT

+86 13605185175

Yahao Zhang, M.D.

Role: CONTACT

+86 13523060936

Facility Contacts

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Tingting Xiao, M.D.

Role: primary

+86 16605198956

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2020ZDSYLL051-P01

Identifier Type: -

Identifier Source: org_study_id

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