Coronary Artery Disease, Dialysis, Intervention
Conditions
Keywords
dialysis, coronary artery disease, revascularization, optimal medical therapy, prognosis
Brief 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.
Interventions
OTHERRevascularization
Percutaneous coronary intervention and/or coronary bypass grafting for coronary artery disease
OTHERMedical therapy
Optimal medical therapy for coronary artery disease
Sponsors
China-Japan Friendship Hospital
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of all-cause death | the duration of hospital stay, an expected average of 2 weeks | All-cause deaths includes cardiac death, vascular death and non-cardiovascular death. 1. 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. 2. Vascular death: caused by noncoronary vascular causes, such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular diseases. 3. 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. |
| Incidence of all-cause death and non-fatal myocardial infarction | 12-month follow-up | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of all-cause death and non-fatal myocardial infarction | within 30 days after discharge | Definitions of all-cause death and non-fatal myocardial infarction as mentioned above. |
| Incidence of all-cause death, non-fatal myocardial infarction, non-fatal stroke, repeat revascularization, cardiovascular rehospitalization. | 12-month follow-up | 1. Definitions of all-cause death and non-fatal myocardial infarction as mentioned above. 2. 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. 3. Repeat revascularization is any unplanned repeat revascularization of either a target vessel or non-target vessel or CABG. 4. Cardiovascular rehospitalization is rehospitalization due to MI, angina, heart failure, stroke, arrhythmia or conduction disturbance, sudden cardiac arrest and other cardiovascular problem. |
| Incidence of bleeding | 12-month follow-up | Bleeding Academic Research Consortium (BARC) type 2 to 5 bleeding. |
Countries
China
Contacts
Primary ContactZhengqin Zhai
Outcome results
None listed