OCTAMI: Optical Coherence Tomography Examination in Acute Myocardial Infarction

Sponsor
China National Center for Cardiovascular Diseases (Other)
Overall Status
Unknown status
CT.gov ID
NCT03593928
Collaborator
(none)
400
1
37
10.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Acute myocardial infarction (AMI), which results from coronary artery occlusion due to thrombosis, remains the leading cause of death and disability worldwide. Pathological studies have demonstrated that plaque rupture accompanied by subsequent thrombus formation is the main mechanism responsible for AMI, accounting for approximately two thirds of cases; the remaining approximately one third of cases are the result of plaque erosion. Moreover, previous studies showed that the risk of cardiovascular events is significantly higher in patients with plaque rupture compared to those with plaque erosion. The EROSION study suggested that in patients with acute coronary syndrome presenting with plaque erosion, conservative treatment with anti-thrombotic therapy may be a reasonable option instead of stents implantation. Therefore, it is important to differentiate between the culprit morphologies in order to perform an accurate risk stratification and determine a personalized treatment strategy with the goal to improve the prognosis of patients with AMI.

    Optical coherence tomography (OCT), a newly developed high resolution near infrared light-based intravascular imaging modality, can visualize the microstructure of atherosclerotic plaques such as the fibrotic cap, lipid pool, thrombi, and so on, and has been considered as the golden standard for differentiating plaque morphology in vivo.

    In this study, we aimed to find risk factors and biomarkers for culprit lesion morphology as assessed by OCT.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    400 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Pre-intervention and Post-intervention Optical Coherence Tomography Examination for Culprit Lesion in Patients With ST-segment Elevation Myocardial Infarction
    Actual Study Start Date :
    Mar 29, 2017
    Anticipated Primary Completion Date :
    Mar 29, 2020
    Anticipated Study Completion Date :
    Apr 29, 2020

    Outcome Measures

    Primary Outcome Measures

    1. culprit lesion morphology as assessed by OCT [1 day (pre-intervention OCT examination of culprit lesion)]

      plaque rupture, plaque erosion or calcified nodule

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • 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

    Exclusion Criteria:
    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chinese Academy of Medical Sciences, Fuwai Hospital Beijing Beijing China 100037

    Sponsors and Collaborators

    • China National Center for Cardiovascular Diseases

    Investigators

    • Principal Investigator: Hongbing Yan, MD, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    hongbing_yan, Co-Director, center of coronary artery disease, Fuwai hospital, China National Center for Cardiovascular Diseases
    ClinicalTrials.gov Identifier:
    NCT03593928
    Other Study ID Numbers:
    • 2018-0710
    First Posted:
    Jul 20, 2018
    Last Update Posted:
    May 16, 2019
    Last Verified:
    May 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by hongbing_yan, Co-Director, center of coronary artery disease, Fuwai hospital, China National Center for Cardiovascular Diseases
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 16, 2019