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NCT Number: NCT02700958

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

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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Key information

Conditions

Atherosclerosis Angina Pectoris Angina, Stable Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Chest Pain Contrast-induced Nephropathy Heart Diseases Myocardial Ischemia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Peripheral Artery Disease Peripheral Vascular Diseases Signs and Symptoms Stable Angina Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tartu University Hospital

Tartu, Tartu County, 50406, Estonia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • 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

Treatment and study plan

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.

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

Primary outcomes

  1. 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.

  2. 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

  1. Cardiac markers

    Time frame: 24 hours

    N-terminal pro-brain natriuretic peptide (NT-proBNP), creatine kinase (CK) MB isoenzyme, troponin T

  2. Traditional biomarkers of renal function

    Time frame: 24 hours

    Urea, creatinine

  3. Novel biomarkers of renal function

    Time frame: 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

  4. Estimated glomerular filtration rate

    Time frame: 24 hours

    eGFR

  5. Markers of oxidative stress and inflammation

    Time frame: 24 hours

    Oxidized low density lipoprotein (oxLDL), interleukin 18 (IL-18), myeloperoxidase (MPO)

  6. Length of hospital stay

    Time frame: 30 days

    Length of hospital stay measured in days.

  7. Adverse events of angiographic procedures

    Time frame: 7 days

    Allergic reactions to iodinated contrast media or local anesthetics

  8. All-cause and cardiovascular mortality

    Time frame: 1 year

    Data of 1-year all-cause and cardiovascular mortality will be collected from the Estonian Causes of Death Registry.

  9. Adverse events associated with femoral artery puncture

    Time frame: 24 hours

    Bleeding, hematoma, arterial thrombosis

  10. Cardiac event

    Time frame: 30 days

    Myocardial infarction or cardiac arrest

  11. Adverse events of remote ischemic preconditioning

    Time frame: 10 days

    Upper-extremity deep vein thrombosis, acute upper limb ischaemia

  12. Low molecular weight metabolites

    Time frame: 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.

  13. Arterial elasticity indices

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Tartu University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Mar 7, 2016
Registry last updated
May 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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