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Clinical Presentations Before AMI Onset and Coronary Atherosclerosis

Sponsor
Harbin Medical University (Other)
Overall Status
Completed
CT.gov ID
NCT03107624
Collaborator
(none)
305
Enrollment
1
Location
12
Actual Duration (Months)
25.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study aimed to evaluate the incidence of preinfarction angina in AMI patients and test the hypothesis that different clinical presentations before AMI onset can affect coronary plaque morphologies in AMI patients .

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Patients with AMI who underwent primary percutaneous coronary intervention（PCI） and optical coherence tomography (OCT) examination is expected to be included in this study.Data about history were prospectively collected by a standard questionaire ,especially regarding the detail information about preinfarction angina.The basic clinical characteristics,angiographic and OCT findings are compared between patients with and without preinfarction angina.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    305 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Pre-infarction Angina and Culprit Plaque Characteristics in Patients With STEMI
    Actual Study Start Date :
    Jun 1, 2016
    Actual Primary Completion Date :
    Jun 1, 2017
    Actual Study Completion Date :
    Jun 1, 2017

    Outcome Measures

    Primary Outcome Measures

    1. Difference in culprit lesion morphologies assessed by OCT according to the presence or absence of PIA [baseline]

      Plaque rupture was defined by the presence of a cavity formation in the plaque with a discontinuity of the fibrous cap. TCFA was defined as a lipid-rich plaque with a thin fibrous cap thickness of ≤ 65 um.Thrombus was identified by OCT as an irregular mass ≧0.25 mm in diameter protruding into the vessel lumen or attached to the surface of the vessel wall.Culprit lesion features in patients with PIA show a lower incidence of plaque rupture and TCFA compared to those without PIA.

    Secondary Outcome Measures

    1. In-hospital outcomes after AMI. [baseline]

      Infarct size was measured as the peak cardiac troponin I (cTnI) level.PIA is associated with lower infarct size and lower in-hospital mortality.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    Inclusion Criteria：

    1. Men or non-pregnant women >18 years of age and < 85 years of age;

    2. Patients undergo cardiac catheterization for AMI;

    3. Patients able to provide written informed consent.

    Exclusion Criteria:

    1. Patients cant afford medical history;

    2. Cardiac shock；

    3. Severe left ventricular dysfunction;

    4. Left main disease;

    5. Hepatic or kidney dysfunction;

    6. OCT was performed after predilation;

    7. Poor OCT image or massive thrombus.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The 2nd Affiliated Hospital of Harbin Medical University Harbin Heilongjiang China

    Sponsors and Collaborators

    • Harbin Medical University

    Investigators

    • Principal Investigator: Bo Yu, MD,PhD, The Second Affiliated Hospital of Harbin Medical University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yu Bo, Director of Cardiology of The 2nd Affiliated Hospital of Harbin Medical University, Harbin Medical University
    ClinicalTrials.gov Identifier:
    NCT03107624
    Other Study ID Numbers:
    • HMUOCT-PIA
    First Posted:
    Apr 11, 2017
    Last Update Posted:
    Dec 2, 2019
    Last Verified:
    May 1, 2018
    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
    Additional relevant MeSH terms:
    Myocardial Infarction
    Infarction

    Study Results

    No Results Posted as of Dec 2, 2019