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Identification of Predictors for Coronary Plaque Erosion in Patients With Acute Coronary Syndrome

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ClinicalTrials.gov Identifier: NCT03479723
Recruitment Status : Recruiting
First Posted : March 27, 2018
Last Update Posted : February 24, 2021
Sponsor:
Information provided by (Responsible Party):
Ik-Kyung Jang, MD, PhD, Massachusetts General Hospital

Tracking Information
First Submitted Date March 14, 2018
First Posted Date March 27, 2018
Last Update Posted Date February 24, 2021
Actual Study Start Date December 1, 2017
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 25, 2018)
Cardiac death [ Time Frame: 3-year ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 14, 2018)
  • all cause death [ Time Frame: 3-year ]
  • myocardial infarction [ Time Frame: 3-year ]
  • stent thrombosis [ Time Frame: 3-year ]
    stent thrombosis was defined according to the Academic Research Consortium criteria
  • any target lesion revascularization [ Time Frame: 3-year ]
    Any revascularization due to thrombosis or restenosis of the target lesion
  • clinically driven target lesion revascularization [ Time Frame: 3-year ]
    target lesion revascularization performed because of ischemic symptoms, electrocardiographic changes at rest or positive stress test relists
  • target-vessel revascularization [ Time Frame: 3-year ]
    Revascularization of any segment of the coronary artery containing the target lesion
  • any repeat revascularization [ Time Frame: 3-year ]
  • stroke [ Time Frame: 3-year ]
  • device-oriented composite (cardiac death, target vessel MI, and TLR) [ Time Frame: 3-year ]
  • bleeding complication [ Time Frame: 3-year ]
    Gusto and BARC definition
  • patients-oriented composite (all cause death, MI, any repeat coronary revascularization) [ Time Frame: 3-year ]
  • target vessel failure (TVF; cardiac death, MI, or ischemia-driven TVR) [ Time Frame: 3-year ]
  • major adverse cardiac events (MACEs: cardiac death, MI, or ischemia-driven TLR) [ Time Frame: 3-year ]
Original Secondary Outcome Measures
 (submitted: March 25, 2018)
  • all cause death [ Time Frame: 3-year ]
  • myocardial infarction [ Time Frame: 3-year ]
  • stent thrombosis [ Time Frame: 3-year ]
    stent thrombosis was defined according to the Academic Research Consortium criteria
  • any target lesion revascularization [ Time Frame: 3-year ]
    Any revascularization due to thrombosis or restenosis of the target lesion
  • clinically driven target lesion revascularization [ Time Frame: 3-year ]
    target lesion revascularizaion performed because of ischemic symptoms, electrocardiographic changes at rest or positive stress test relists
  • target-vessel revascularization [ Time Frame: 3-year ]
    Revascularization of any segment of the coronary artery containing the target lesion
  • any repeat revascularization [ Time Frame: 3-year ]
  • stroke [ Time Frame: 3-year ]
  • device-oriented composite (cardiac death, target vessel MI, and TLR) [ Time Frame: 3-year ]
  • bleeding complication [ Time Frame: 3-year ]
    Gusto and BARC definition
  • patients-oriented composite (all cause death, MI, any repeat coronary revascularization) [ Time Frame: 3-year ]
  • target vessel failure (TVF; cardiac death, MI, or ischemia-driven TVR) [ Time Frame: 3-year ]
  • major adverse cardiac events (MACEs: cardiac death, MI, or ischemia-driven TLR) [ Time Frame: 3-year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Identification of Predictors for Coronary Plaque Erosion in Patients With Acute Coronary Syndrome
Official Title Identification of Predictors for Coronary Plaque Erosion in Patients With Acute Coronary Syndrome
Brief Summary The purpose of this study is to perform pooled analysis with data collected from 5 previously published studies and 8 unpublished datasets collected from international sites. The main goal of this study is to identify the predictors of plaque erosion.
Detailed Description Plaque erosion is reported to be responsible for about one third of patients with acute coronary syndrome (ACS). In the EROSION study, we reported that antithrombotic therapy without stenting achieved a reduction in thrombus volume greater than 50% in over 70% of patients diagnosed with ACS caused by plaque erosion. This result suggests that the conservative approach of anti-thrombotic therapy without stenting may be an option for patients diagnosed with ACS caused by plaque erosion, which may be the paradigm shift in treatment of ACS patients. However, at present, the only way to make an in vivo diagnosis of plaque erosion is intra-coronary optical coherence tomography (OCT). If we can identify clinical factors associated with plaque erosion, we may be able to narrow down a sub-population of patients with a higher likelihood of plaque erosion. This group of patients may be stabilized with pharmacologic therapy and avoid invasive procedures, thereby preventing related complications and reducing health care burden. However, specific demographic characteristics of the ACS patients with plaque erosion are not known. Our group has the world's largest dataset of patients with plaque erosion and several published reports on plaque erosion. However, the study population of each study is still small and unbalanced to identify the demographic characteristics associated with plaque erosion. Therefore, we propose to pool data from a large number of institutions around the world. This will provide an opportunity to identify factors associated with plaque erosion.
Study Type Observational [Patient Registry]
Study Design Observational Model: Case-Only
Time Perspective: Other
Target Follow-Up Duration 3 Years
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients with diagnosis of ACS confirmed by OCT imaging of the culprit lesion.
Condition Acute Coronary Syndrome
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 25, 2018)
2000
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Diagnosed with ACS upon admission to hospital, including patients with ST-elevation myocardial infarction (STEMI), non-ST elevation myocardial infarction (NSTEMI), and unstable angina pectoris (UAP).
  2. Intra-vascular OCT imaging of culprit vessel.

Exclusion Criteria:

  • None
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Ik-Kyung Jang, MD, PhD 617-726-9226 IJANG@mgh.harvard.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03479723
Other Study ID Numbers 2017P000329
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Ik-Kyung Jang, MD, PhD, Massachusetts General Hospital
Study Sponsor Massachusetts General Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Ik-Kyung Jang, MD, PhD Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date February 2021