Novel Serum Biomarkers for Identifying Plaque Erosion in ACS and Predicting Prognosis

NCT ID: NCT06763835

Last Updated: 2025-01-14

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

ACTIVE_NOT_RECRUITING

Total Enrollment

301 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-01

Study Completion Date

2026-07-30

Brief Summary

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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.

Detailed Description

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Conditions

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Plaque Rupture Acute Coronary Syndromes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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acute coronary syndrome casued by plaque erosion(PE-ACS)

acute coronary syndrome patients casued by plaque erosion as identified by invasive optical coherence tomography in catheter labs.(PE-ACS)

Blood is drawn to test for specific biomarkers

Intervention Type DIAGNOSTIC_TEST

After identifying characteristic biomarkers that can distinguish between PE-ACS and PR-ACS, we draw blood from ACS patients for testing to assist in determining whether the ACS subtype is PE-ACS or PR-ACS.

acute coronary syndrome casued by plaque rupture(PR-ACS)

acute coronary syndrome patients casued by plaque rupture as identified by invasive optical coherence tomography in catheter labs.(PR-ACS)

Blood is drawn to test for specific biomarkers

Intervention Type DIAGNOSTIC_TEST

After identifying characteristic biomarkers that can distinguish between PE-ACS and PR-ACS, we draw blood from ACS patients for testing to assist in determining whether the ACS subtype is PE-ACS or PR-ACS.

Interventions

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Blood is drawn to test for specific biomarkers

After identifying characteristic biomarkers that can distinguish between PE-ACS and PR-ACS, we draw blood from ACS patients for testing to assist in determining whether the ACS subtype is PE-ACS or PR-ACS.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xuebo Liu

OTHER

Sponsor Role lead

Responsible Party

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Xuebo Liu

Medical Doctor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Tongji Hospital, Tongj University School of Medicine, 200333, Shanghai ,China

Shanghai, , China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 22922416 (View on PubMed)

Roffi M, Patrono C, Collet JP, Mueller C, Valgimigli M, Andreotti F, Bax JJ, Borger MA, Brotons C, Chew DP, Gencer B, Hasenfuss G, Kjeldsen K, Lancellotti P, Landmesser U, Mehilli J, Mukherjee D, Storey RF, Windecker S; ESC Scientific Document Group. 2015 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation: Task Force for the Management of Acute Coronary Syndromes in Patients Presenting without Persistent ST-Segment Elevation of the European Society of Cardiology (ESC). Eur Heart J. 2016 Jan 14;37(3):267-315. doi: 10.1093/eurheartj/ehv320. Epub 2015 Aug 29. No abstract available.

Reference Type BACKGROUND
PMID: 26320110 (View on PubMed)

Johnson TW, Raber L, Di Mario C, Bourantas CV, Jia H, Mattesini A, Gonzalo N, de la Torre Hernandez JM, Prati F, Koskinas KC, Joner M, Radu MD, Erlinge D, Regar E, Kunadian V, Maehara A, Byrne RA, Capodanno D, Akasaka T, Wijns W, Mintz GS, Guagliumi G. Clinical use of intracoronary imaging. Part 2: acute coronary syndromes, ambiguous coronary angiography findings, and guiding interventional decision-making: an expert consensus document of the European Association of Percutaneous Cardiovascular Interventions. EuroIntervention. 2019 Aug 29;15(5):434-451. doi: 10.4244/EIJY19M06_02.

Reference Type BACKGROUND
PMID: 31258132 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27578806 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23810884 (View on PubMed)

Other Identifiers

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ITJ(QN)2203

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

18411950300

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

TJH-2023-010

Identifier Type: -

Identifier Source: org_study_id

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