Clinical trial NCT05841082: Coronary Revascularization in Patients On Dialysis in China-Retrospective Registry
Official title: Coronary RevascUlarIzation in Patients With End-StagE Renal Disease on Dialysis in China-Retrospective Registry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
End Stage Renal Disease
Dialysis
Keywords: coronary artery disease
end-stage renal disease
cardiac catheterizations
percutaneous coronary intervention
coronary artery bypass grafting
prognosis
metabolic Syndrome
revascularization
optimal medical therapy
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
Collaborators: name: Aerospace Center Hospital
name: Beijing Chao Yang Hospital
name: Cangzhou Central Hospital of Tianjin Medical University
name: Civil Aviation General Hospital
name: Dongguan Tungwah Hospital
name: Emergency General Hospital
name: Fifth Affiliated Hospital of Xinjiang Medical University
name: First Central Hospital of Tianjin
name: Fuwai Yunnan Cardiovascular Hospital
name: Guangdong Provincial People's Hospital
name: Henan Provincial Chest Hospital
name: Ningbo No. 1 Hospital
name: Peking University People's Hospital
name: Peking University Shougang Hospital
name: People's Hospital of Xinjiang Uygur Autonomous Region
name: Tianjin Medical University Second Hospital
name: Shaoxing People's Hospital
name: Shengjing Hospital
name: First Affiliated Hospital of Xinjiang Medical University
name: the First Affiliated Hospital, Harbin Medical University
name: Zhejiang University
name: People's Hospital of Guangxi Zhuang Autonomous Region
name: The Third People's Hospital of Chengdu
name: Tianjin Medical University General Hospital
name: Tianjin Union Medicine Center
name: Tongji Hospital
name: West China Hospital
name: Xuanwu Hospital, Beijing
name: Wuhan University
First posted: 2023-05-03
Enrollment: 1249
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_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

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.


Eligibility criteria: Inclusion Criteria:

* 50% 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

Exclusion Criteria:

-

Primary outcomes:
measure: All-cause death
timeFrame: 12-month follow-up
Secondary outcomes:
measure: Major adverse cardiovascular events
timeFrame: From the hospital admission to 12-month follow-up
measure: Major or clinically relevant nonmajor bleeding
timeFrame: From the hospital admission to 12-month follow-up
measure: Cardiovascular death
timeFrame: From the hospital admission to 12-month follow-up
measure: Non-fatal myocardial infarction
timeFrame: From the hospital admission to 12-month follow-up
measure: Non-fatal myocardial stroke
timeFrame: From the hospital admission to 12-month follow-up
measure: Major bleeding
timeFrame: From the hospital admission to 12-month follow-up
measure: Clinically relevant nonmajor bleeding
timeFrame: From the hospital admission to 12-month follow-up
measure: Follow-up major adverse cardiovascular and clinical events
timeFrame: From the hospital admission, and up to 10 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
Study officials:
affiliation: China-Japan Friendship Hospital
name: Jingang Zheng, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: