CHRONIC RENAL DISEASE
Conditions
Brief summary
incidence of the primary event consisting of: death from cardiovascular causes; acute coronary syndrome; angina requiring hospitalisation; coronary revascularisation; transient ischaemic attack or non-cardioembolic ischaemic stroke; or peripheral vascular disease, defined as acute peripheral arterial embolism or ischaemia, or the need for amputation or percutaneous surgical revascularisation, Incidence of primary event consisting of death from cardiovascular causes; acute coronary syndrome; angina requiring hospitalization; coronary revascularization; transient ischemic attack or noncardioembolic ischemic stroke; or peripheral vasculopathy, defined as embolism or acute peripheral arterial ischemia, or need for amputation or surgical or percutaneous revascularization.
Detailed description
- Incidence of death from cardiovascular causes. - Incidence of acute coronary syndrome. - Incidence of hospitalization for cardiac angina. - Incidence of coronary revascularization. - Incidence of transient ischemic attack or noncardioembolic ischemic stroke. - Incidence of peripheral vasculopathy, defined as embolism or acute peripheral arterial ischemia, or need for amputation or percutaneous surgical revascularization., - Individual and combined incidence of renal events: o 40% decrease in glomerular filtration rate estimated by CKD-EPI with respect to baseline. o Doubling of serum creatinine over its baseline level. o Persistent drop in glomerular filtration rate estimated by CKD-EPI below 15 mL/min/1.73m2. o Need for renal replacement therapy on a sustained basis. - Effect on plasma levels of markers of inflammation, fibrosis and renal progression. - Incidence of adverse events.
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| incidence of the primary event consisting of: death from cardiovascular causes; acute coronary syndrome; angina requiring hospitalisation; coronary revascularisation; transient ischaemic attack or non-cardioembolic ischaemic stroke; or peripheral vascular disease, defined as acute peripheral arterial embolism or ischaemia, or the need for amputation or percutaneous surgical revascularisation, Incidence of primary event consisting of death from cardiovascular causes; acute coronary syndrome; angina requiring hospitalization; coronary revascularization; transient ischemic attack or noncardioembolic ischemic stroke; or peripheral vasculopathy, defined as embolism or acute peripheral arterial ischemia, or need for amputation or surgical or percutaneous revascularization. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Incidence of death from cardiovascular causes. - Incidence of acute coronary syndrome. - Incidence of hospitalization for cardiac angina. - Incidence of coronary revascularization. - Incidence of transient ischemic attack or noncardioembolic ischemic stroke. - Incidence of peripheral vasculopathy, defined as embolism or acute peripheral arterial ischemia, or need for amputation or percutaneous surgical revascularization., - Individual and combined incidence of renal events: o 40% decrease in glomerular filtration rate estimated by CKD-EPI with respect to baseline. o Doubling of serum creatinine over its baseline level. o Persistent drop in glomerular filtration rate estimated by CKD-EPI below 15 mL/min/1.73m2. o Need for renal replacement therapy on a sustained basis. - Effect on plasma levels of markers of inflammation, fibrosis and renal progression. - Incidence of adverse events. | — |
Countries
Spain