Clinical trial NCT06763835: Novel Serum Biomarkers for Identifying Plaque Erosion in ACS and Predicting Prognosis
Official title: Development and Validation of Diagnostic and Prognostic Model of Acute Coronary Syndrome Caused by Plaque Erosion Using Novel Serum Biomarkers
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Plaque Rupture
Acute Coronary Syndromes
Keywords: plaque erosion
plaque rupture
acute coronary syndrome
Lead sponsor: Shanghai Tongji Hospital, Tongji University School of Medicine
Sponsor class: OTHER
First posted: 2025-01-08
Enrollment: 301
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population of individuals with suspected acute coronary syndrome seeking treatment at the Department of Cardiology, Tongji Hospital, Shanghai.

Brief summary: The goal of this observational study is to find novel serum biomarkers for the accurate diagnosis of plaque erosion (PE) from acute coronary syndrome (ACS) and help predicting the prognosis of PE. The main question it aims to answer is

• Whether novel serum biomarkers could facilitate the non-invasive diagnosis and prognosis prediction of PE ? Participants will be contacted at 1,2,5 year after the diagnosis of PE-ACS or other reasons of ACS.


Eligibility criteria: Inclusion Criteria:

people presenting with an acute coronary syndrome (ACS)-either non-ST-segment elevation myocardial infarction (NSTE-ACS); or ST-segment elevation myocardial infarction (STE-ACS), and subsequently underwent emergent coronary angiography followed by percutaneous coronary intervention (PCI). Culprit leisions were tested using optical coheren tomograpgy and pathological diagnosis(PE OR PR) were validated by 2 independent experienced core lab members.

Exclusion Criteria:

* patients younger than 18 years or older than 85 years
* patients in cardiogenic shock
* prior coronary artery bypass grafting,
* patients with corornary stent thrombosis
* patients with left main coronary disease
* patients with congestive heart failure
* patients with life-threatening arrhythmia
* patients with thrombocytopenia patients with significant hepatic or renal impairment
* patients with septicemia, leukopenia, active inflammatory or malignant disease
* other factors compromising high-quality optical coherence tomography (OCT) imaging (e.g., severe vessel tortuosity or calcification, persistent no-reflow, lesions in distal segments, or an indeterminate culprit lesion)
* Individuals unable to provide informed consent were also excluded.

Primary outcomes:
measure: Specific biomarkers can serve as diagnostic and prognostic indicators for subclassifying PE-ACS or PR-ACS.
timeFrame: From enrollment to the end of the follow-up at 1,2,5 year
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Tongji Hospital, Tongj University School of Medicine, 200333, Shanghai ,China
Study officials:
References:
citation: Task Force on the management of ST-segment elevation acute myocardial infarction of the European Society of Cardiology (ESC); Steg PG, James SK, Atar D, Badano LP, Blomstrom-Lundqvist C, Borger MA, Di Mario C, Dickstein K, Ducrocq G, Fernandez-Aviles F, Gershlick AH, Giannuzzi P, Halvorsen S, Huber K, Juni P, Kastrati A, Knuuti J, Lenzen MJ, Mahaffey KW, Valgimigli M, van 't Hof A, Widimsky P, Zahger D. ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation. Eur Heart J. 2012 Oct;33(20):2569-619. doi: 10.1093/eurheartj/ehs215. Epub 2012 Aug 24. No abstract available.
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citation: Jia H, Dai J, Hou J, Xing L, Ma L, Liu H, Xu M, Yao Y, Hu S, Yamamoto E, Lee H, Zhang S, Yu B, Jang IK. Effective anti-thrombotic therapy without stenting: intravascular optical coherence tomography-based management in plaque erosion (the EROSION study). Eur Heart J. 2017 Mar 14;38(11):792-800. doi: 10.1093/eurheartj/ehw381.
citation: Jia H, Abtahian F, Aguirre AD, Lee S, Chia S, Lowe H, Kato K, Yonetsu T, Vergallo R, Hu S, Tian J, Lee H, Park SJ, Jang YS, Raffel OC, Mizuno K, Uemura S, Itoh T, Kakuta T, Choi SY, Dauerman HL, Prasad A, Toma C, McNulty I, Zhang S, Yu B, Fuster V, Narula J, Virmani R, Jang IK. In vivo diagnosis of plaque erosion and calcified nodule in patients with acute coronary syndrome by intravascular optical coherence tomography. J Am Coll Cardiol. 2013 Nov 5;62(19):1748-58. doi: 10.1016/j.jacc.2013.05.071. Epub 2013 Jun 27.