Remote Ischemic Preconditioning as a Method Against Subclinical Renal Injury and Contrast-induced Nephropathy

Not Applicable

Completed

• Conditions: Contrast-induced Nephropathy; Stable Angina; Atherosclerosis; Peripheral Artery Disease
• Interventions: Procedure: SHAM Remote ischemic preconditioning; Procedure: Remote ischemic preconditioning

• Registration Number: NCT02700958
• Lead Sponsor: Tartu University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-02-03
• Study First Submitted QC: 2016-03-04
• Study First Posted: 2016-03-07
• Primary Completion: 2018-03-19
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-16
• Last Update Posted: 2018-05-17
• Study Completion: 2019-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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

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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
• Inability to understand the instructions of the study
• Vascular surgery in axillary region
• Unable to lie supine for 40 minutes
• Home oxygen treatment
• Documented upper limb deep vein thrombosis

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SHAM remote ischemic preconditioning	SHAM Remote ischemic preconditioning	SHAM Remote Ischemic Preconditioning (RIPC-SHAM) is accomplished by alternating 4 cycles of 5-minute inflation with 5-minute deflation. Blood pressure cuff will be inflated to 10-20 mmHg. RIPC-SHAM is performed with standard blood pressure cuff on upper-arm.
Remote ischemic preconditioning	Remote ischemic preconditioning	Remote Ischemic Preconditioning (RIPC) is performed by inflating blood pressure cuff for 5-minutes at 200 mmHg, or if patients systolic blood pressure is higher than 200 mmHg 20 mmHg above systolic pressure, alternated with 5-minute deflation for 4 times.

Primary Outcome Measures

Name	Time	Method
Change in carotid-femoral pulse wave velocity compared with baseline and SHAM subgroup	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	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 Outcome Measures

Name	Time	Method
Adverse events of angiographic procedures	7 days	Allergic reactions to iodinated contrast media or local anesthetics
Adverse events of remote ischemic preconditioning	10 days	Upper-extremity deep vein thrombosis, acute upper limb ischaemia
Cardiac markers	24 hours	N-terminal pro-brain natriuretic peptide (NT-proBNP), creatine kinase (CK) MB isoenzyme, troponin T
Markers of oxidative stress and inflammation	24 hours	Oxidized low density lipoprotein (oxLDL), interleukin 18 (IL-18), myeloperoxidase (MPO)
Estimated glomerular filtration rate	24 hours	eGFR
Traditional biomarkers of renal function	24 hours	Urea, creatinine
Novel biomarkers of renal function	24 hours	Neutrophil gelatinase-associated lipocalin (NGAL), renal liver-type fatty acid binding protein (L-FABP), kidney injury molecule-1 (KIM-1), isoprostane, cystatin C, beta-2 microglobulin
Length of hospital stay	30 days	Length of hospital stay measured in days.
Cardiac event	30 days	Myocardial infarction or cardiac arrest
Low molecular weight metabolites	24 hours	Amino acids (alanine, arginine, asparagine, aspartate, citrulline, cysteine, glutamine, glutamate, glycine, histidine, hydroxyproline, leucine, lysine, methionine, ornithine, phenylalanine, proline, serine, threonine, tryptophan, tyrosine, valine), acylcarnitines (free carnitine, acylcarnitine, propionylcarnitine, butyrylcarnitine, pentanoylcarnitine, hexanoylcarnitine, octanoylcarnitine, decanoylcarnitine, tetradecanoylcarnitine, octadecanoylcarnitine), hydroxy acids and other metabolic parameters (aconitate, α-ketoglutarate, β-hydroxybutyrate, citrate, citrulline, 7-ketocholesterol, lactate, malonate, oxaloacetate, pyruvate, succinate) will be measured.
All-cause and cardiovascular mortality	1 year	Data of 1-year all-cause and cardiovascular mortality will be collected from the Estonian Causes of Death Registry.
Adverse events associated with femoral artery puncture	24 hours	Bleeding, hematoma, arterial thrombosis
Arterial elasticity indices	24 hours	Arterial elasticity 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 HD/PulseWave™ CR-2000.

Trial Locations

Locations (1)

Tartu University Hospital; 🇪🇪 Tartu, Tartu County, Estonia