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

NCT02700958 | Completed

• 1 other identifier: 16003
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (13)

• Cardiac markers

  24 hours

• Traditional biomarkers of renal function

  24 hours

• Novel biomarkers of renal function

  24 hours

• Estimated glomerular filtration rate

  24 hours

• Markers of oxidative stress and inflammation

  24 hours

Study Arms (2)

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.

Procedure: Remote ischemic preconditioning

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.

Procedure: SHAM Remote ischemic preconditioning

Interventions

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.

Remote ischemic preconditioning

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

SHAM remote ischemic preconditioning

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tartu University Hospital: lead

Study Sites (1)

Tartu University Hospital

Tartu, Tartu County, 50406, Estonia

Location

Related Publications (1)

• 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.

  PMID: 36645250 DERIVED

MeSH Terms

Conditions

Atherosclerosis; Angina, Stable; Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Angina Pectoris; Myocardial Ischemia; Heart Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Vascular Diseases

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Tartu University Hospital, Clinic of Surgery, Department of Vascular Surgery, cardiovascular surgeon; MD-PhD

Study Record Dates

• First Submitted: February 3, 2016
• First Posted: March 7, 2016
• Study Start: February 1, 2016
• Primary Completion: March 19, 2018
• Study Completion: March 19, 2019
• Last Updated: May 17, 2018

Record last verified: 2018-05

Locations

ES (1)