Clinical trial NCT02700958: Remote Ischemic Preconditioning as a Method Against Subclinical Renal Injury and Contrast-induced Nephropathy
Official title: Study of Remote Ischemic Preconditioning as a Preventative Method Against Subclinical Renal Injury and Contrast-induced Nephropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atherosclerosis
Stable Angina
Peripheral Artery Disease
Contrast-induced Nephropathy
Keywords: Remote ischemic preconditioning
Contrast-induced Nephropathy
Stable coronary artery disease
Lower extremity arterial disease
Low molecular weight metabolites
Functional properties of arteries
Lead sponsor: Tartu University Hospital
Sponsor class: OTHER
First posted: 2016-03-07
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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
* 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

Primary outcomes:
measure: Change in carotid-femoral pulse wave velocity compared with baseline and SHAM subgroup
timeFrame: 24 hours
measure: Change in augmentation indices (augmentation index and heart rate-corrected augmentation index (AIx@75)) compared with baseline and SHAM subgroup
timeFrame: 24 hours
Secondary outcomes:
measure: Cardiac markers
timeFrame: 24 hours
measure: Traditional biomarkers of renal function
timeFrame: 24 hours
measure: Novel biomarkers of renal function
timeFrame: 24 hours
measure: Estimated glomerular filtration rate
timeFrame: 24 hours
measure: Markers of oxidative stress and inflammation
timeFrame: 24 hours
measure: Length of hospital stay
timeFrame: 30 days
measure: Adverse events of angiographic procedures
timeFrame: 7 days
measure: All-cause and cardiovascular mortality
timeFrame: 1 year
measure: Adverse events associated with femoral artery puncture
timeFrame: 24 hours
measure: Cardiac event
timeFrame: 30 days
measure: Adverse events of remote ischemic preconditioning
timeFrame: 10 days
measure: Low molecular weight metabolites
timeFrame: 24 hours
measure: Arterial elasticity indices
timeFrame: 24 hours
Other outcomes:
Locations:
city: Tartu
country: Estonia
facility: Tartu University Hospital
state: Tartu County
Study officials:
affiliation: Tartu University Hospital
name: Jaan Eha, MD, PhD
role: STUDY_CHAIR
affiliation: Tartu University Hospital
name: Jaak Kals, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Tartu
name: Mihkel Zilmer, MD, PhD
role: STUDY_CHAIR
affiliation: University of Tartu
name: Karl Kuusik, MD
role: STUDY_DIRECTOR
affiliation: University of Tartu
name: Teele Kepler, MD
role: STUDY_CHAIR
References: