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The effects of chronic kidney disease in ischemic cardiomyopathy

The effect of chronic kidney disease in ischemic cardiomyopathy: Long-term follow-up - REVISION-DM2 Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN17786790
Enrollment
918
Registered
2018-08-22
Start date
2011-05-25
Completion date
Unknown
Last updated
2020-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic kidney disease in ischemic cardiomyopathy Urological and Genital Diseases Chronic kidney disease in ischemic cardiomyopathy

Interventions

This study will include 2160 patients with coronary artery disease (CAD) previously treated by surgery, percutaneous revascularization, or medical treatment in an outpatient follow-up for 5 years. The

Sponsors

Zerbini Foundation
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Stable angina 2. Multi-vessel coronary artery disease 3. Had an evaluation of left ventricular function 4. Aged 18 years or older

Exclusion criteria

Exclusion criteria: 1. In dialysis programs 2. Pacemaker 3. Defibrillators 4. Reduced life expectancy 5. Degenerative diseases

Design outcomes

Primary

MeasureTime frame
The following are assessed throughout the study, from the date of inclusion to the end of the study: 1. Mortality from any cause 2. Non-fatal myocardial infarction, defined as the following: 2.1. Elevation of specific cardiac enzymes within 14 days of a revascularization procedure 2.2. Presence of new Q waves in at least 2 or more contiguous leads 2.3. CK-MB (creatine kinase-muscle/brain)( or troponin US elevation, 10 times above normal level 3. Unplanned cardiac surgery - the need for unplanned revascularization, after symptoms of angina after coronary surgery with or without cardiopulmonary bypass 4. Stroke, defined as one of the following: 4.1. Patients with a focal neurological deficit of central origin, lasting more than 72 hours 4.2. Focal neurological deficit of central origin, lasting more than 24 hours, with imaging evidence of cerebral infarction or intracerebral haemorrhage 4.3. Non-focal encephalopathy, with imaging evidence of cerebral infarction 4.4. Haemorrhage adequate to account for the clinical state 5. Hospital admissions for cardiac causes, including the following: 5.1. Anginal symptoms 5.2. Heart failure 5.3. Generalized edema 5.4. Cardiac arrhythmia 6. Hospital admissions for renal causes, including the following: 6.1. Loss of urinary volume 6.2. Increase of plasmatic potassium without specific cause 6.3. Generalised edema

Secondary

MeasureTime frame
Quality of life, assessed every 6 months for 5 years using a questionnaire evaluating topics including the following: 1. Pain 2. Vitality 3. Emotional aspects 4. Physical aspects

Countries

Brazil

Contacts

Public ContactThiago Hueb

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 21, 2026