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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remote ischemic preconditioning | Experimental | 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. |
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| SHAM remote ischemic preconditioning | Sham Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote ischemic preconditioning | Procedure | Remote ischemic preconditioning is performed with standard blood pressure cuff on upper-arm. RIPC will be started just before the coronarography or angiography. Time between the last inflation cycle and the beginning of the procedure will be less than 60 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in carotid-femoral pulse wave velocity compared with baseline and SHAM subgroup | 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. | 24 hours |
| Change in augmentation indices (augmentation index and heart rate-corrected augmentation index (AIx@75)) compared with baseline and SHAM subgroup | 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. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac markers | N-terminal pro-brain natriuretic peptide (NT-proBNP), creatine kinase (CK) MB isoenzyme, troponin T | 24 hours |
| Traditional biomarkers of renal function | Urea, creatinine |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jaan Eha, MD, PhD | Tartu University Hospital | Study Chair |
| Jaak Kals, MD, PhD | Tartu University Hospital | Principal Investigator |
| Mihkel Zilmer, MD, PhD | University of Tartu | Study Chair |
| Karl Kuusik, MD | University of Tartu | Study Director |
| Teele Kepler, MD | University of Tartu | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tartu University Hospital | Tartu | Tartu County | 50406 | Estonia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36645250 | Derived | Liang F, Liu S, Liu G, Liu H, Wang Q, Song B, Yao L. Remote ischaemic preconditioning versus no remote ischaemic preconditioning for vascular and endovascular surgical procedures. Cochrane Database Syst Rev. 2023 Jan 16;1(1):CD008472. doi: 10.1002/14651858.CD008472.pub3. |
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|
| SHAM Remote ischemic preconditioning | Procedure | SHAM Remote ischemic preconditioning is performed with standard blood pressure cuff on upper-arm. RIPC-SHAM will be started just before the coronarography or angiography. Time between the last inflation cycle and the beginning of the procedure will be less than 60 minutes |
|
| 24 hours |
| Novel biomarkers of renal function | 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 | 24 hours |
| Estimated glomerular filtration rate | eGFR | 24 hours |
| Markers of oxidative stress and inflammation | Oxidized low density lipoprotein (oxLDL), interleukin 18 (IL-18), myeloperoxidase (MPO) | 24 hours |
| Length of hospital stay | Length of hospital stay measured in days. | 30 days |
| Adverse events of angiographic procedures | Allergic reactions to iodinated contrast media or local anesthetics | 7 days |
| All-cause and cardiovascular mortality | Data of 1-year all-cause and cardiovascular mortality will be collected from the Estonian Causes of Death Registry. | 1 year |
| Adverse events associated with femoral artery puncture | Bleeding, hematoma, arterial thrombosis | 24 hours |
| Cardiac event | Myocardial infarction or cardiac arrest | 30 days |
| Adverse events of remote ischemic preconditioning | Upper-extremity deep vein thrombosis, acute upper limb ischaemia | 10 days |
| Low molecular weight metabolites | 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. | 24 hours |
| Arterial elasticity indices | 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. | 24 hours |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D060050 | Angina, Stable |
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000787 | Angina Pectoris |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016491 | Peripheral Vascular Diseases |
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