Plaque RuptureNBPE-ACSNCT06763835
Novel Serum Biomarkers for Identifying Plaque Erosion in ACS and Predicting Prognosis
An observational study of Plaque Rupture and Acute Coronary Syndromes, run by Xuebo Liu at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Plaque Rupture, Acute Coronary Syndromes
- What is being tested?
- Blood is drawn to test for specific biomarkers
- How many people
- 301 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2023to 30 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population of individuals with suspected acute coronary syndrome seeking treatment at the Department of Cardiology, Tongji Hospital, Shanghai.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Tongji Hospital, Tongj University School of Medicine, 200333, Shanghai ,China
Shanghai, 200333
About this study
Official title: Development and Validation of Diagnostic and Prognostic Model of Acute Coronary Syndrome Caused by Plaque Erosion Using Novel Serum Biomarkers
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.
- Conditions
- Plaque Rupture, Acute Coronary Syndromes
- Being tested
- Blood is drawn to test for specific biomarkers
- Keywords
- plaque erosion, plaque rupture, acute coronary syndrome
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood is drawn to test for specific biomarkersDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Diagnostic Test: Blood is drawn to test for specific biomarkers | |
| 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) Receives: Diagnostic Test: Blood is drawn to test for specific biomarkers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Specific biomarkers can serve as diagnostic and prognostic indicators for subclassifying PE-ACS or PR-ACS.
Specific biomarkers(Methylation sites, mRNA etc,.) can serve as diagnostic and prognostic indicators for subclassifying PE-ACS or PR-ACS.
Measured: From enrollment to the end of the follow-up at 1,2,5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2025
- Study start1 Feb 2023
- Primary completion30 Jul 2024
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Plaque RuptureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 301 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xuebo Liu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xuebo Liu, Shanghai Tongji Hospital, Tongji University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06763835
- Sponsor's protocol ID
- TJH-2023-010
- Other IDs
- ITJ(QN)2203, 18411950300
- Acronym
- NBPE-ACS
- Status last verified
- Jan 2025
- First submitted
- 2 Jan 2025
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22922416Roffi 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.
PubMed 26320110Johnson 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.
PubMed 31258132Jia 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.
PubMed 27578806Jia 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.
PubMed 23810884
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of Diagnostic and Prognostic Model of Acute Coronary Syndrome Caused by Plaque Erosion Using Novel Serum Biomarkers
- ClinicalTrials.gov ID
- NCT06763835
- Acronym / sponsor ID
- NBPE-ACS / TJH-2023-010
- Conditions
- Plaque Rupture, Acute Coronary Syndromes
- Keywords
- plaque erosion, plaque rupture, acute coronary syndrome
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 301 participants (actual)
- Lead sponsor
- Xuebo LiuUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 8 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| acute coronary syndrome casued by plaque erosion(PE-ACS) | – | Diagnostic Test: Blood is drawn to test for specific biomarkersacute coronary syndrome patients casued by plaque erosion as identified by invasive optical coherence tomography in catheter labs.(PE-ACS) |
| acute coronary syndrome casued by plaque rupture(PR-ACS) | – | Diagnostic Test: Blood is drawn to test for specific biomarkersacute coronary syndrome patients casued by plaque rupture as identified by invasive optical coherence tomography in catheter labs.(PR-ACS) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population of individuals with suspected acute coronary syndrome seeking treatment at the Department of Cardiology, Tongji Hospital, Shanghai.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood is drawn to test for specific biomarkersAfter 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. | Diagnostic test | acute coronary syndrome casued by plaque erosion(PE-ACS), acute coronary syndrome casued by plaque rupture(PR-ACS) |
Primary outcome
Specific biomarkers can serve as diagnostic and prognostic indicators for subclassifying PE-ACS or PR-ACS.
Time frame: From enrollment to the end of the follow-up at 1,2,5 year
Specific biomarkers(Methylation sites, mRNA etc,.) can serve as diagnostic and prognostic indicators for subclassifying PE-ACS or PR-ACS.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
- Background: PubMed 22922416Task 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.
- Background: PubMed 26320110Roffi 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.
- Background: PubMed 31258132Johnson 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.
- Background: PubMed 27578806Jia 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.
- Background: PubMed 23810884Jia 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Plaque Rupture and Acute Coronary Syndromes, run by Xuebo Liu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Specific biomarkers can serve as diagnostic and prognostic indicators for subclassifying PE-ACS or PR-ACS. (time frame: From enrollment to the end of the follow-up at 1,2,5 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06763835, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2025.