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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04953819
Other study ID # 2020-112-K71
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 1, 2020
Est. completion date August 31, 2023

Study information

Verified date June 2021
Source China-Japan Friendship Hospital
Contact Zhengqin Zhai
Phone +86 18612511571
Email zhengqin712@outlook.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

China patients in end stage renal disease receiving maintenance dialysis have a high risk of cardiovascular disease (CVD), with a prevalence of 45.5% approximately, and coronary artery disease (CAD) has been identified as the most common one. It remains unclear that what their treatment status is and whether this group of patients can benefit from revascularization in China. The investigators plan to recruit around 30 hospitals from 7 regions as study centers, which represent different levels of economic development in Mainland China. The detailed information includes demographics, medical history, coronary angiogram, in-hospital treatment and procedures, short-term and long-term outcomes. The aim of the study is to provide the real world knowledge about current status of coronary revascularization and prognosis in patients with CAD and dialysis.


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date August 31, 2023
Est. primary completion date August 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: - Aged 18 or above and 85 or below. - Receives peritoneal dialysis or hemodialysis more than 1-time weekly and for more than 3 months. - Diagnosed with coronary artery disease, including STEMI, NST-ACD, stable coronary artery disease. Exclusion Criteria: - Pregnancy or lactation. - Can't be cooperative because of a mental illness or other reasons. - Malignant tumor or severe hepatic disease. - Life expectancy is less than 1 year.

Study Design


Intervention

Other:
Revascularization
Percutaneous coronary intervention and/or coronary bypass grafting for coronary artery disease
Medical therapy
Optimal medical therapy for coronary artery disease

Locations

Country Name City State
China China-Japan Friendship Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
China-Japan Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of all-cause death All-cause deaths includes cardiac death, vascular death and non-cardiovascular death.
Cardiac death: any death due to proximate cardiac cause (eg, MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, and all procedure-related deaths, including those related to concomitant treatment, will be classified as cardiac death.
Vascular death: caused by noncoronary vascular causes, such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular diseases.
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.
the duration of hospital stay, an expected average of 2 weeks
Primary Incidence of all-cause death and non-fatal myocardial infarction Non-fatal myocardial infarction is defined as elevated cardiac enzymes (troponin or myocardial band fraction of creatine kinase) above the upper reference limit with ischemic symptoms or electrocardiography findings indicative of ischemia that is not related to the index procedure. 12-month follow-up
Secondary Incidence of all-cause death and non-fatal myocardial infarction Definitions of all-cause death and non-fatal myocardial infarction as mentioned above. within 30 days after discharge
Secondary Incidence of all-cause death, non-fatal myocardial infarction, non-fatal stroke, repeat revascularization, cardiovascular rehospitalization. Definitions of all-cause death and non-fatal myocardial infarction as mentioned above.
Non-fatal stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause.
Repeat revascularization is any unplanned repeat revascularization of either a target vessel or non-target vessel or CABG.
Cardiovascular rehospitalization is rehospitalization due to MI, angina, heart failure, stroke, arrhythmia or conduction disturbance, sudden cardiac arrest and other cardiovascular problem.
12-month follow-up
Secondary Incidence of bleeding Bleeding Academic Research Consortium (BARC) type 2 to 5 bleeding. 12-month follow-up
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