Study of Remote Ischemic Preconditioning as a Preventative Method Against Subclinical Renal Injury and Contrast-induced Nephropathy
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Atherosclerosis
- Sponsor
- Tartu University Hospital
- Enrollment
- 160
- Locations
- 1
- Primary Endpoint
- Change in carotid-femoral pulse wave velocity compared with baseline and SHAM subgroup
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
Contrast-induced nephropathy (CIN) has remained significant and severe complication of angiographic procedures despite the increasing use of preventative methods. It has been associated with prolonged hospital stay, high morality and the need for dialysis. Since classically used creatinine for diagnosing of CIN does not reflect the degree of tubular injury before 24-48 hours after exposure to contrast media alternative earlier biomarkers and preventative methods are needed. Remote ischemic preconditioning is a non-invasive and safe method which in some studies has been reported to protect against contrast-induced nephropathy. The purpose of this study is to evaluate the effect of remote ischemic preconditioning (RIPC) (1) as an additional method to standard treatment to prevent subclinical and clinical contrast-induced acute kidney injury and (2) to assess its effect on functional properties of arterial wall, organ damage biomarkers and low molecular weight metabolites.
Investigators
Jaak Kals
Tartu University Hospital, Clinic of Surgery, Department of Vascular Surgery, cardiovascular surgeon; MD-PhD
Tartu University Hospital
Eligibility Criteria
Inclusion Criteria
- •Age greater than 18 years, no upper age limit
- •Patients with stable coronary artery disease (II - III class according to the Canadian Cardiovascular Society) hospitalized for coronarography or with lower extremity arterial disease hospitalized for angiography
- •Written informed consent
Exclusion Criteria
- •Pregnancy
- •Age less than 18 years
- •eGFR \< 30 ml/min/1,73 m2
- •Simultaneous participation in an other clinical trial
- •Coexisting pathology of the upper-limbs limiting the use of the cuff (bilateral amputee, recent trauma, chronic ulcers, significant upper limb peripheral atherosclerosis (radial pulse not palpable on either side))
- •Malignant tumor (in remission less than 5 years or ongoing treatment)
- •Documented allergic reaction to iodinated contrast agent
- •Acute infection (body temperature 38 degrees Celsius or higher, c reactive protein 50mg/L or higher)
- •Cardiac rhythm abnormalities (atrial fibrillation, frequent supraventricular premature complexes)
- •Documented myocardial infarction within 30 days
Outcomes
Primary Outcomes
Change in carotid-femoral pulse wave velocity compared with baseline and SHAM subgroup
Time Frame: 24 hours
Carotid-femoral pulse wave velocity baseline measurement is performed. Second measuring is performed 24 hours after angiographic procedure. Change from baseline will be compared between RIPC and SHAM subgroups. Measuring is performed with SphygmoCor XCEL PWA and PWV Device.
Change in augmentation indices (augmentation index and heart rate-corrected augmentation index (AIx@75)) compared with baseline and SHAM subgroup
Time Frame: 24 hours
Augmentation indices baseline measurement is performed. Second measuring is performed 24 hours after angiographic procedure. Change from baseline will be compared between RIPC and SHAM subgroups. Measuring is performed with SphygmoCor XCEL PWA and PWV Device.
Secondary Outcomes
- Adverse events of angiographic procedures(7 days)
- Adverse events of remote ischemic preconditioning(10 days)
- Cardiac markers(24 hours)
- Markers of oxidative stress and inflammation(24 hours)
- Estimated glomerular filtration rate(24 hours)
- Traditional biomarkers of renal function(24 hours)
- Novel biomarkers of renal function(24 hours)
- Length of hospital stay(30 days)
- Cardiac event(30 days)
- Low molecular weight metabolites(24 hours)
- All-cause and cardiovascular mortality(1 year)
- Adverse events associated with femoral artery puncture(24 hours)
- Arterial elasticity indices(24 hours)