NCT05841082

Brief Summary

Coronary artery disease (CAD) is the leading cause of death in end-stage renal disease (ESRD) patients requiring dialysis. There are limited data on clinical characteristics, treatment strategies and outcomes in this special patient population in China. As a nationwide, observational, multicenter cohort study, this study consecutively included ESRD patients on dialysis with significant CAD at 30 tertiary care centers in 12 provinces in China from January 2015 to June 2021. Patient data collected included demographics, comorbidities, cardiac history, cardiac function, location and severity of CAD, procedural information, medications, and clinical events.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,249

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

January 1, 2015

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

April 22, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 3, 2023

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

May 6, 2023

Status Verified

May 1, 2023

Enrollment Period

6.5 years

First QC Date

April 22, 2023

Last Update Submit

May 4, 2023

Conditions

Coronary Artery DiseaseEnd Stage Renal DiseaseDialysis

Keywords

coronary artery diseaseend-stage renal diseasecardiac catheterizationspercutaneous coronary interventioncoronary artery bypass graftingprognosismetabolic Syndromerevascularizationoptimal medical therapy

Outcome Measures

Primary Outcomes (1)

  • All-cause death

    All-cause deaths include cardiovascular death and non-cardiovascular death. Cardiovascular death is defined as death due to acute myocardial infarction, heart failure, sudden cardiac death, stroke, cardiovascular procedure, or cardiovascular hemorrhage. Non-cardiovascular death: any death not covered by the above definitions, such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide, or trauma.

    12-month follow-up

Secondary Outcomes (8)

  • Major adverse cardiovascular events

    From the hospital admission to 12-month follow-up

  • Major or clinically relevant nonmajor bleeding

    From the hospital admission to 12-month follow-up

  • Cardiovascular death

    From the hospital admission to 12-month follow-up

  • Non-fatal myocardial infarction

    From the hospital admission to 12-month follow-up

  • Non-fatal myocardial stroke

    From the hospital admission to 12-month follow-up

  • +3 more secondary outcomes

Study Arms (1)

CAD

The investigators recruited all consecutive end-stage renal disease patients requiring dialysis who had significant coronary artery disease, defined as 50% or greater stenosis in any of three main coronary arteries or left main coronary artery on visual assessment of the coronary angiogram

Eligibility Criteria

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

The population of this study will be selected from January 2015 to June 2021 among 30 tertiary medical centers across 12 provinces in China

You may qualify if:

  • % or greater stenosis in any of three main coronary arteries or left main coronary artery on visual assessment of the coronary angiogram
  • Receive peritoneal dialysis or hemodialysis for more than 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

Location

Related Publications (1)

  • Xie E, Wu Y, Ye Z, He Y, Zeng H, Luo J, Chen M, Pang W, Xu Y, Gao C, Guo X, Cai L, Ji Q, Yang Y, Wu D, Yuan Y, Wan J, Ma Y, Zhang J, Du Z, Yang Q, Cheng J, Ding C, Ma X, Yin C, Fan Z, Tang Q, Li Y, Sun L, Lu C, Chi J, Yao Z, Gao Y, Yu C, Ren J, Zheng J. Percutaneous coronary intervention vs . medical therapy in patients on dialysis with coronary artery disease in China. Chin Med J (Engl). 2025 Feb 5;138(3):301-310. doi: 10.1097/CM9.0000000000003295. Epub 2024 Sep 25.

    PMID: 39317971DERIVED

MeSH Terms

Conditions

Coronary Artery DiseaseKidney Failure, ChronicMetabolic Syndrome

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesRenal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Jingang Zheng, MD, PhD

    China-Japan Friendship Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Cardiology

Study Record Dates

First Submitted

April 22, 2023

First Posted

May 3, 2023

Study Start

January 1, 2015

Primary Completion

June 30, 2021

Study Completion

June 30, 2024

Last Updated

May 6, 2023

Record last verified: 2023-05

Locations

CN(1)