Skip to main content

Table 2 Definition of CVD events as parts of the primary outcome

From: Vitamin D receptor activator and prevention of cardiovascular events in hemodialysis patients—rationale and design of the Japan Dialysis Active Vitamin D (J-DAVID) trial

Acute myocardial infarction:
 Clinical signs and symptoms such as chest pain or cardiogenic shock, associated with abnormalities in biomarkers (creatine kinase, troponin, etc.) and/or electric cardiogram (new abnormal Q-wave, ST elevation, etc.) for myocardial infarction
Congestive heart failure:
 Congestive heart failure (NYHA grade III or IV) requiring hospitalization, excluding dyspnea due to non-cardiac causes (bronchial asthma, etc.)
Stroke:
 Rapidly developing clinical signs of neurological deficit attributable to a focal and/or total brain functions, without clear causes than vascular origin, lasting for more than 24 h or leading to death (if not interrupted by surgical operations or death). Stroke includes subarachnoidal hemorrhage, intracranial hemorrhage, and cerebral infarction but excludes transient ischemic attack, cerebrovascular disease due to hematological disorders (leukemia, polycytemia vera, etc.), primary brain tumors, and metastatic brain tumors. Stroke secondary to trauma is also excluded
Aortic dissection/rupture:
 Clinical symptom of chest pain and/or abdominal pain, and diagnosed with imaging test such as contrast enhanced computed tomography
Amputation of ischemic limb:
 Major amputations at ankle joint or proximal as treatment for patients with symptom and/or signs of lower extremity ischemia
Cardiac sudden death:
 Unexpected death from a cardiac cause that occurs within one hour of symptom onset (witnessed) or within 24 h of last being observed in normal health (unwitnessed)