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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03479723
Recruitment Status : Recruiting
First Posted : March 27, 2018
Last Update Posted : February 24, 2021
Information provided by (Responsible Party):
Ik-Kyung Jang, MD, PhD, Massachusetts General Hospital

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The purpose of this study is to perform pooled analysis with data collected from 5 previously published studies and 8 unpublished datasets collected from international sites.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.

Condition or disease
Acute Coronary Syndrome

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 2000 participants
Observational Model: Case-Only
Time Perspective: Other
Target Follow-Up Duration: 3 Years
Official Title: Identification of Predictors for Coronary Plaque Erosion in Patients With Acute Coronary Syndrome
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Primary Outcome Measures :
  1. Cardiac death [ Time Frame: 3-year ]

Secondary Outcome Measures :
  1. all cause death [ Time Frame: 3-year ]
  2. myocardial infarction [ Time Frame: 3-year ]
  3. stent thrombosis [ Time Frame: 3-year ]
    stent thrombosis was defined according to the Academic Research Consortium criteria

  4. any target lesion revascularization [ Time Frame: 3-year ]
    Any revascularization due to thrombosis or restenosis of the target lesion

  5. 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

  6. target-vessel revascularization [ Time Frame: 3-year ]
    Revascularization of any segment of the coronary artery containing the target lesion

  7. any repeat revascularization [ Time Frame: 3-year ]
  8. stroke [ Time Frame: 3-year ]
  9. device-oriented composite (cardiac death, target vessel MI, and TLR) [ Time Frame: 3-year ]
  10. bleeding complication [ Time Frame: 3-year ]
    Gusto and BARC definition

  11. patients-oriented composite (all cause death, MI, any repeat coronary revascularization) [ Time Frame: 3-year ]
  12. target vessel failure (TVF; cardiac death, MI, or ischemia-driven TVR) [ Time Frame: 3-year ]
  13. major adverse cardiac events (MACEs: cardiac death, MI, or ischemia-driven TLR) [ Time Frame: 3-year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with diagnosis of ACS confirmed by OCT imaging of the culprit lesion.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03479723

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Contact: Ik-Kyung Jang, MD, PhD 617-726-9226

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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Ik-Kyung Jang, MD. PhD    617-726-9226   
Sponsors and Collaborators
Massachusetts General Hospital
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Principal Investigator: Ik-Kyung Jang, MD, PhD Massachusetts General Hospital
Additional Information:

Publications automatically indexed to this study by Identifier (NCT Number):

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Responsible Party: Ik-Kyung Jang, MD, PhD, Professor of Medicine; Director, Cardiology Laboratory for Integrative Physiology & Imaging, Massachusetts General Hospital Identifier: NCT03479723    
Other Study ID Numbers: 2017P000329
First Posted: March 27, 2018    Key Record Dates
Last Update Posted: February 24, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases