NCT03593928

Brief Summary

Different plaque morphology may have an important effect on the prognosis of acute myocardial infarction (AMI), as recent studies show that patients with plaque rupture have a significantly higher risk of cardiac events compared with those with plaque erosion. The primary purpose of this study is to find risk factors and biomarkers for different culprit lesion morphology to perform accurate risk stratification and determine an appropriate treatment strategy for patients with AMI.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 29, 2017

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 11, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 20, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 29, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 29, 2020

Completed
Last Updated

May 16, 2019

Status Verified

May 1, 2019

Enrollment Period

3 years

First QC Date

July 11, 2018

Last Update Submit

May 15, 2019

Conditions

Myocardial InfarctionOptical Coherence Tomography

Keywords

biomarkerplaque morphology

Outcome Measures

Primary Outcomes (1)

  • culprit lesion morphology as assessed by OCT

    plaque rupture, plaque erosion or calcified nodule

    1 day (pre-intervention OCT examination of culprit lesion)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients (age ≥18 years) who presented with STEMI and underwent emergent procedures were prospectively screened for OCT examination of the culprit lesion.

You may qualify if:

  • Patients with ST-segment elevation myocardial infarction (defined as continuous chest pain lasted \>30 min, ST-segment elevation \>0.1 mV in at least two contiguous leads or new left bundle-branch block on the 18-lead electrocardiogram (ECG), and an elevated troponin I level)
  • Age ≥18 years
  • Provide written informed consent

You may not qualify if:

  • Cardiac shock
  • History of coronary artery bypass graft
  • Left main diseases, extremely tortuous or heavily calcified vessels, or chronic total occlusion
  • Inability to obtain Thrombolysis in myocardial infarction flow grade ≥ 2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese Academy of Medical Sciences, Fuwai Hospital

Beijing, Beijing Municipality, 100037, China

RECRUITING

Related Publications (13)

  • Li J, Chen R, Zhou J, Wang Y, Zhao X, Liu C, Zhou P, Chen Y, Song L, Yan S, Yan H, Zhao H. Associations of Culprit Vessel Size and Plaque Characteristics in Patients with ST-Segment Elevation Myocardial Infarction. Rev Cardiovasc Med. 2023 Jun 29;24(7):186. doi: 10.31083/j.rcm2407186. eCollection 2023 Jul.

    PMID: 39077009DERIVED

  • Zhao X, Zhao H, Chen R, Li J, Zhou J, Li N, Yan S, Liu C, Zhou P, Chen Y, Song L, Yan H. A Combined Measure of the Triglyceride Glucose Index and Trimethylamine N-Oxide in Risk Stratification of ST-Segment Elevation Myocardial Infarction Patients with High-Risk Plaque Features Defined by Optical Coherence Tomography: A Substudy of the OCTAMI Registry Study. Vasc Health Risk Manag. 2024 Mar 29;20:141-155. doi: 10.2147/VHRM.S443742. eCollection 2024.

    PMID: 38567028DERIVED

  • Li N, Zhou J, Chen R, Zhao X, Li J, Zhou P, Liu C, Chen Y, Wang Y, Song L, Yan S, Zhao H, Yan H. Prognostic impacts of diabetes status and lipoprotein(a) levels in patients with ST-segment elevation myocardial infarction: a prospective cohort study. Cardiovasc Diabetol. 2023 Jun 26;22(1):151. doi: 10.1186/s12933-023-01881-w.

    PMID: 37365608DERIVED

  • Li N, Chen R, Li J, Zhao X, Wang Y, Zhou J, Zhou P, Liu C, Chen Y, Song L, Yan S, Zhao H, Yan H. Prognostic significance of serial N-terminal pro-B-type natriuretic peptide levels in patients with acute myocardial infarction: A prospective study. Am Heart J. 2023 Aug;262:90-99. doi: 10.1016/j.ahj.2023.04.015. Epub 2023 Apr 26.

    PMID: 37116605DERIVED

  • Zhao X, Wang Y, Chen R, Li J, Zhou J, Liu C, Zhou P, Sheng Z, Chen Y, Song L, Zhao H, Yan H. Prognostic value of characteristics of plaque combined with residual syntax score among patients with STEMI undergoing primary PCI: an intravascular optical coherence tomography study. Thromb J. 2021 Nov 12;19(1):85. doi: 10.1186/s12959-021-00329-z.

    PMID: 34772417DERIVED

  • Wang Y, Zhao X, Zhou P, Liu C, Sheng Z, Li J, Zhou J, Chen R, Chen Y, Song L, Zhao H, Yan H. Plasma Pentraxin-3 Combined with Plaque Characteristics Predict Cardiovascular Risk in ST-Segment Elevated Myocardial Infarction: An Optical Coherence Tomography Study. J Inflamm Res. 2021 Sep 2;14:4409-4419. doi: 10.2147/JIR.S330600. eCollection 2021.

    PMID: 34511975DERIVED

  • Wang Y, Zhao X, Zhou P, Liu C, Sheng Z, Li J, Zhou J, Chen R, Chen Y, Song L, Zhao H, Yan H. Residual SYNTAX Score in Relation to Coronary Culprit Plaque Characteristics and Cardiovascular Risk in ST Segment Elevation Myocardial Infarction: an Intravascular Optical Coherence Tomography Study. J Cardiovasc Transl Res. 2022 Feb;15(1):75-83. doi: 10.1007/s12265-021-10152-6. Epub 2021 Jul 9.

    PMID: 34244969DERIVED

  • Zhou J, Chen R, Liu C, Zhou P, Li J, Wang Y, Zhao X, Zhao H, Song L, Yan H. Associations of NETs with inflammatory risk and atherosclerotic severity in ST-segment elevation myocardial infarction. Thromb Res. 2021 Jul;203:5-11. doi: 10.1016/j.thromres.2021.04.015. Epub 2021 Apr 19.

    PMID: 33894474DERIVED

  • Li J, Tan Y, Zhou P, Liu C, Zhao H, Song L, Zhou J, Chen R, Wang Y, Zhao X, Chen Y, Yan H. Association of Trimethylamine N-Oxide Levels and Calcification in Culprit Lesion Segments in Patients With ST-Segment-Elevation Myocardial Infarction Evaluated by Optical Coherence Tomography. Front Cardiovasc Med. 2021 Feb 24;8:628471. doi: 10.3389/fcvm.2021.628471. eCollection 2021.

    PMID: 33718451DERIVED

  • Zhou J, Yu S, Tan Y, Zhou P, Liu C, Sheng Z, Li J, Chen R, Zhao S, Yan H. Trimethylamine N-Oxide Was Not Associated With 30-Day Left Ventricular Systolic Dysfunction in Patients With a First Anterior ST-Segment Elevation Myocardial Infarction After Primary Revascularization: A Sub-analysis From an Optical Coherence Tomography Registry. Front Cardiovasc Med. 2020 Dec 23;7:613684. doi: 10.3389/fcvm.2020.613684. eCollection 2020.

    PMID: 33426008DERIVED

  • Zhou J, Sheng Z, Liu C, Zhou P, Li J, Chen R, Song L, Zhao H, Yan H. Association between Admission Hyperglycemia and Culprit Lesion Characteristics in Nondiabetic Patients with Acute Myocardial Infarction: An Intravascular Optical Coherence Tomography Study. J Diabetes Res. 2020 Jun 20;2020:1763567. doi: 10.1155/2020/1763567. eCollection 2020.

    PMID: 32685552DERIVED

  • Sheng Z, Zhou P, Liu C, Li J, Chen R, Zhou J, Song L, Zhao H, Yan H. Relationships of coronary culprit-plaque characteristics with duration of diabetes mellitus in acute myocardial infarction: an intravascular optical coherence tomography study. Cardiovasc Diabetol. 2019 Oct 19;18(1):136. doi: 10.1186/s12933-019-0944-8.

    PMID: 31629406DERIVED

  • Tan Y, Sheng Z, Zhou P, Liu C, Zhao H, Song L, Li J, Zhou J, Chen Y, Wang L, Qian H, Sun Z, Qiao S, Xu B, Gao R, Yan H. Plasma Trimethylamine N-Oxide as a Novel Biomarker for Plaque Rupture in Patients With ST-Segment-Elevation Myocardial Infarction. Circ Cardiovasc Interv. 2019 Jan;12(1):e007281. doi: 10.1161/CIRCINTERVENTIONS.118.007281.

    PMID: 30599768DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

plasma; serum; monocyte

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Hongbing Yan, MD

    Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hongbing Yan, MD

CONTACT

008601088322281bcc_ami@126.com

Yu Tan, PhD

CONTACT

008601088322287fuwaity@126.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Co-Director, center of coronary artery disease, Fuwai hospital

Study Record Dates

First Submitted

July 11, 2018

First Posted

July 20, 2018

Study Start

March 29, 2017

Primary Completion

March 29, 2020

Study Completion

April 29, 2020

Last Updated

May 16, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)