NCT04935086

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
370

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 3, 2021

Completed
19 days until next milestone

First Posted

Study publicly available on registry

June 22, 2021

Completed
8 days until next milestone

Study Start

First participant enrolled

June 30, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2021

Completed
Last Updated

December 12, 2024

Status Verified

December 1, 2024

Enrollment Period

5 months

First QC Date

June 3, 2021

Last Update Submit

December 7, 2024

Conditions

Coronary Artery Disease

Keywords

Risk FactorsCABGRadial ArteryMACE

Outcome Measures

Primary Outcomes (4)

  • 7-day MACE-4

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

    7 days post-CABG

  • 30-day MACE-4

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

    30 days post-CABG

  • 1-year MACE-4

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

    1 year post-CABG

  • 3-year MACE-4

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

    3 years post-CABG

Secondary Outcomes (6)

  • MACE-3

    7 days, 30 days, 1 year, and 3 years post-CABG

  • All-cause death

    7 days, 30 days, 1 year, and 3 years post-CABG

  • CV-death

    7 days, 30 days, 1 year, and 3 years post-CABG

  • Myocardial infraction

    7 days, 30 days, 1 year, and 3 years post-CABG

  • Stroke

    7 days, 30 days, 1 year, and 3 years post-CABG

  • +1 more secondary outcomes

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients 18-year and above underwent RA-CABG from Jan. 2009 to Dec.2019 in one single center.

You may qualify if:

  • 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

You may not qualify if:

  • With unavailable medical records

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruijin Hospital Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

Related Publications (1)

  • Xia T, Li B, Zhang W, Wang Z, Ye X, Zhou M, Li H, Qiu J, Zhu Y, Zhao Q. Risk factors for major adverse cardiovascular events after coronary artery bypass grafting using radial artery grafts. Front Cardiovasc Med. 2023 Sep 27;10:1238161. doi: 10.3389/fcvm.2023.1238161. eCollection 2023.

    PMID: 37829689BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Qiang Zhao, MD

    Ruijin Hospital

    PRINCIPAL INVESTIGATOR

  • Yunpeng Zhu, MD

    Ruijin Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Director, Department of Cardiovascular Surgery, Vice President, Ruijin Hospital

Study Record Dates

First Submitted

June 3, 2021

First Posted

June 22, 2021

Study Start

June 30, 2021

Primary Completion

November 30, 2021

Study Completion

November 30, 2021

Last Updated

December 12, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)