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Peripheral Vascular Disease and Coronary Artery Disease

Sponsor
Harbin Medical University (Other)
Overall Status
Completed
CT.gov ID
NCT03971864
Collaborator
(none)
350
Enrollment
1
Location
13.7
Actual Duration (Months)
25.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study aims at evaluating the relationship between peripheral artery plaque characteristics evaluated by ultrasound and coronary culprit lesion characteristics evaluated by OCT in ACS patients.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Patients with acute coronary syndrome (ACS) who underwent percutaneous coronary intervention (PCI) and optical coherence tomography (OCT) are included in this study. Two skillful echocardiographers will evaluate peripheral artery plaque characteristics by ultrasound.Ultrasound parameters of peripheral artery will be compared among patients with different coronary culprit lesion characteristics, such as plaque rupture and plaque erosion.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    350 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Relationship Between Peripheral Artery Plaque Characteristics Evaluated by Ultrasound and Coronary Culprit Lesion Characteristics Evaluated by OCT in ACS Patients
    Actual Study Start Date :
    Nov 8, 2018
    Actual Primary Completion Date :
    Dec 31, 2019
    Actual Study Completion Date :
    Dec 31, 2019

    Outcome Measures

    Primary Outcome Measures

    1. Differences in ultrasound parameters of peripheral artery plaque according to different coronary culprit lesion morphology. [Baseline]

      Plaque rupture is characterized by the presence of fibrous cap discontinuity with a cavity formation. plaque erosion is characterized by the presence of the attached thrombus overlying an intact and visual plaque, luminal surface irregularity at the culprit lesion in the absence of thrombus, or attenuation of the underlying plaque by thrombus without superficial lipid or calcification immediately proximal or distal to the site of thrombus.Patients with plaque erosion have less plaques, lower intima-media thickness (IMT), lower plaque score (PS) compared to patients with plaque rupture.

    Eligibility Criteria

    Criteria

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

    • Diagnosed as ACS underwent coronary angiography and OCT examination

    • Agreed to accept peripheral artery ultrasound examination

    Exclusion Criteria:

    • In-stent restenosis, coronary dissection, coronary spam, thrombus

    • left main artery disease

    • Age>85 years old

    • Cardiogenic shock or stroke admission

    • Severe hepatic or renal dysfunction

    • Poor quality of OCT image or massive thrombus

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Second Affiliated Hospital of Harbin Medical University Harbin Heilongjiang China 150081

    Sponsors and Collaborators

    • Harbin Medical University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yu Bo, Director of Cardiology of The Seconf Affiliated Hospital of Harbin Mdical University, Harbin Medical University
    ClinicalTrials.gov Identifier:
    NCT03971864
    Other Study ID Numbers:
    • HMUOCT-PAU
    First Posted:
    Jun 3, 2019
    Last Update Posted:
    Sep 16, 2020
    Last Verified:
    Sep 1, 2020
    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:
    Acute Coronary Syndrome

    Study Results

    No Results Posted as of Sep 16, 2020