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Optical Coherence Tomography Examination in Acute Myocardial Infarction (OCTAMI)

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ClinicalTrials.gov Identifier: NCT03593928
Recruitment Status : Recruiting
First Posted : July 20, 2018
Last Update Posted : May 16, 2019
Sponsor:
Information provided by (Responsible Party):
hongbing_yan, China National Center for Cardiovascular Diseases

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
Myocardial Infarction Optical Coherence Tomography

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.


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Study Type : Observational
Estimated 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 : March 29, 2017
Estimated Primary Completion Date : March 29, 2020
Estimated Study Completion Date : April 29, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack




Primary Outcome Measures :
  1. culprit lesion morphology as assessed by OCT [ Time Frame: 1 day (pre-intervention OCT examination of culprit lesion) ]
    plaque rupture, plaque erosion or calcified nodule


Biospecimen Retention:   Samples With DNA
plasma; serum; monocyte


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:   Non-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.
Criteria

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

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 ClinicalTrials.gov identifier (NCT number): NCT03593928


Contacts
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Contact: Hongbing Yan, MD 008601088322281 bcc_ami@126.com
Contact: Yu Tan, PhD 008601088322287 fuwaity@126.com

Locations
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China, Beijing
Chinese Academy of Medical Sciences, Fuwai Hospital Recruiting
Beijing, Beijing, China, 100037
Contact: Hongbing Yan, MD    (0086)10+88322281    bcc_ami@126.com   
Contact: Yu Tan, PhD    (0086)10+88322287    fuwaity@126.com   
Sponsors and Collaborators
China National Center for Cardiovascular Diseases
Investigators
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Principal Investigator: Hongbing Yan, MD Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: hongbing_yan, Co-Director, center of coronary artery disease, Fuwai hospital, China National Center for Cardiovascular Diseases
ClinicalTrials.gov Identifier: NCT03593928     History of Changes
Other Study ID Numbers: 2018-0710
First Posted: July 20, 2018    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by hongbing_yan, China National Center for Cardiovascular Diseases:
biomarker
plaque morphology

Additional relevant MeSH terms:
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Infarction
Myocardial Infarction
ST Elevation Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases