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Risk Factors for Predictors of MACEs After RA-CABG

Sponsor
Ruijin Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04935086
Collaborator
(none)
370
Enrollment
1
Location
5
Actual Duration (Months)
73.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

As the secondary choice of artery grafts, radial artery is more and more used to achieve multiple arterial revascularization in CABG. Risk factors for predictors of major cardiovascular adverse events (MACE) after CABG using radial-artery grafts (RA-CABG), however, remain uncertain. This case-control study aims to identify the baseline predictors of MACE after RA-CABG.

We will collect the baseline characteristics and perioperative data of patients underwent RA-CABG from Jan. 2009 to Dec. 2019 in our single center. By reviewing the latest follow-up records, we will examine the correlation between the baseline characteristics and clinical outcomes (MACEs), then identify the independent risk factors for predictors of MACEs after RA-CABG.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    370 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Retrospective
    Official Title:
    Risk Factors for Predictors of Major Adverse Cardiovascular Events After Coronary Artery Bypass Using Radial Artery Grafts
    Actual Study Start Date :
    Jun 30, 2021
    Actual Primary Completion Date :
    Nov 30, 2021
    Actual Study Completion Date :
    Nov 30, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    MACE Group

    MACE Group includes the patients suffered from any component of MACE after RA-CABG until the latest follow-up.
    Non-MACE Group

    Non-MACE Group includes the patients freed from any component of MACE after RA-CABG until the latest follow-up.

    Outcome Measures

    Primary Outcome Measures

    1. 7-day MACE-4 [7 days post-CABG]

      a composite of all-cause death, myocardial infraction, stroke and repeat revascularization

    2. 30-day MACE-4 [30 days post-CABG]

      a composite of all-cause death, myocardial infraction, stroke and repeat revascularization

    3. 1-year MACE-4 [1 year post-CABG]

      a composite of all-cause death, myocardial infraction, stroke and repeat revascularization

    4. 3-year MACE-4 [3 years post-CABG]

      a composite of all-cause death, myocardial infraction, stroke and repeat revascularization

    Secondary Outcome Measures

    1. MACE-3 [7 days, 30 days, 1 year, and 3 years post-CABG]

      a composite of CV-death, myocardial infraction and stroke

    2. All-cause death [7 days, 30 days, 1 year, and 3 years post-CABG]

      Death from any cause

    3. CV-death [7 days, 30 days, 1 year, and 3 years post-CABG]

      Including death resulting from an acute myocardial infarction , sudden cardiac death, death due to heart failure, death due to stroke, death due to cardiovascular procedures, death due to cardiovascular hemorrhage, and death due to other cardiovascular causes

    4. Myocardial infraction [7 days, 30 days, 1 year, and 3 years post-CABG]

      According to the 2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials, including CABG-related MI, non CABG-related MI, silent MI and unknown type.

    5. Stroke [7 days, 30 days, 1 year, and 3 years post-CABG]

      According to the 2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials, including ischemic, hemorrhagic and unknown type.

    6. Repeat revascularization [7 days, 30 days, 1 year, and 3 years post-CABG]

      According to the 2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials, including any PCI and CABG.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Underwent CABG using at least a radial artery grafts from Jan.2009 to Dec.2019. with or without cardiopulmonary bypass , with or without concomitant procedure

    • Aged 18 and above at procedure

    • With any gender

    Exclusion Criteria:
    • With unavailable medical records

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ruijin Hospital Shanghai Jiao Tong University School of Medicine Shanghai Shanghai China 200025

    Sponsors and Collaborators

    • Ruijin Hospital

    Investigators

    • Principal Investigator: Qiang Zhao, MD, Ruijin Hospital
    • Principal Investigator: Yunpeng Zhu, MD, Ruijin Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Qiang Zhao,MD, Professor and Director, Department of Cardiovascular Surgery, Vice President, Ruijin Hospital, Ruijin Hospital
    ClinicalTrials.gov Identifier:
    NCT04935086
    Other Study ID Numbers:
    • KY-2020388
    First Posted:
    Jun 22, 2021
    Last Update Posted:
    Dec 1, 2021
    Last Verified:
    Nov 1, 2021
    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
    Keywords provided by Qiang Zhao,MD, Professor and Director, Department of Cardiovascular Surgery, Vice President, Ruijin Hospital, Ruijin Hospital
    Risk Factors
    CABG
    Radial Artery
    MACE
    Additional relevant MeSH terms:
    Coronary Artery Disease

    Study Results

    No Results Posted as of Dec 1, 2021