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

Atherosclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02700958
• Other study ID #: 16003
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: March 19, 2019

Study information

• Verified date: May 2018
• Source: Tartu University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: March 19, 2019
• Est. primary completion date: March 19, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Angina, Stable
• Atherosclerosis
• Contrast-induced Nephropathy
• Kidney Diseases
• Peripheral Arterial Disease
• Peripheral Artery Disease
• Stable Angina

Intervention

Procedure:
• Remote ischemic preconditioning
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
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

Locations

Country	Name	City	State
Estonia	Tartu University Hospital	Tartu	Tartu County

Sponsors (1)

Lead Sponsor	Collaborator
Tartu University Hospital

Country where clinical trial is conducted

Estonia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	Cardiac markers	N-terminal pro-brain natriuretic peptide (NT-proBNP), creatine kinase (CK) MB isoenzyme, troponin T	24 hours
Secondary	Traditional biomarkers of renal function	Urea, creatinine	24 hours
Secondary	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
Secondary	Estimated glomerular filtration rate	eGFR	24 hours
Secondary	Markers of oxidative stress and inflammation	Oxidized low density lipoprotein (oxLDL), interleukin 18 (IL-18), myeloperoxidase (MPO)	24 hours
Secondary	Length of hospital stay	Length of hospital stay measured in days.	30 days
Secondary	Adverse events of angiographic procedures	Allergic reactions to iodinated contrast media or local anesthetics	7 days
Secondary	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
Secondary	Adverse events associated with femoral artery puncture	Bleeding, hematoma, arterial thrombosis	24 hours
Secondary	Cardiac event	Myocardial infarction or cardiac arrest	30 days
Secondary	Adverse events of remote ischemic preconditioning	Upper-extremity deep vein thrombosis, acute upper limb ischaemia	10 days
Secondary	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, a-ketoglutarate, ß-hydroxybutyrate, citrate, citrulline, 7-ketocholesterol, lactate, malonate, oxaloacetate, pyruvate, succinate) will be measured.	24 hours
Secondary	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