AtherosclerosisNCT02700958
Remote Ischemic Preconditioning as a Method Against Subclinical Renal Injury and Contrast-induced Nephropathy
A study testing Remote ischemic preconditioning in people with Atherosclerosis and Stable Angina, run by Tartu University Hospital at 1 site in Estonia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atherosclerosis, Stable Angina, Peripheral Artery Disease
- What is being tested?
- Remote ischemic preconditioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteEstonia
- Study dates
- Feb 2016to 19 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Remote Ischemic Preconditioning as a Preventative 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.
- Being tested
- Remote ischemic preconditioning, SHAM Remote ischemic preconditioning
- Keywords
- Remote ischemic preconditioning, Contrast-induced Nephropathy, Stable coronary artery disease, Lower extremity arterial disease, Low molecular weight metabolites, Functional properties of arteries
- Medical subject headings
- Atherosclerosis, Angina, Stable, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote ischemic preconditioningProcedure or surgery
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 preconditioningProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: SHAM Remote ischemic preconditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 24 hours
Secondary outcomes (13)
Cardiac markers
N-terminal pro-brain natriuretic peptide (NT-proBNP), creatine kinase (CK) MB isoenzyme, troponin T
Measured: 24 hours
Traditional biomarkers of renal function
Urea, creatinine
Measured: 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
Measured: 24 hours
Estimated glomerular filtration rate
eGFR
Measured: 24 hours
Markers of oxidative stress and inflammation
Oxidized low density lipoprotein (oxLDL), interleukin 18 (IL-18), myeloperoxidase (MPO)
Measured: 24 hours
Length of hospital stay
Length of hospital stay measured in days.
Measured: 30 days
Adverse events of angiographic procedures
Allergic reactions to iodinated contrast media or local anesthetics
Measured: 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.
Measured: 1 year
Adverse events associated with femoral artery puncture
Bleeding, hematoma, arterial thrombosis
Measured: 24 hours
Cardiac event
Myocardial infarction or cardiac arrest
Measured: 30 days
Adverse events of remote ischemic preconditioning
Upper-extremity deep vein thrombosis, acute upper limb ischaemia
Measured: 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.
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.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completion19 Mar 2018
- Study completion19 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tartu University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaak Kals, Tartu University Hospital
- Investigators
- Jaan Eha, MD, PhD, Study chair, Tartu University HospitalJaak Kals, MD, PhD, Principal investigator, Tartu University HospitalMihkel Zilmer, MD, PhD, Study chair, University of TartuKarl Kuusik, MD, Study director, University of TartuTeele Kepler, MD, Study chair, University of Tartu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02700958
- Sponsor's protocol ID
- 16003
- Status last verified
- May 2018
- First submitted
- 3 Feb 2016
- Last updated
- 17 May 2018
- Results posted
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 36645250
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Remote Ischemic Preconditioning as a Preventative Method Against Subclinical Renal Injury and Contrast-induced Nephropathy
- ClinicalTrials.gov ID
- NCT02700958
- Acronym / sponsor ID
- 16003
- Keywords
- Remote ischemic preconditioning, Contrast-induced Nephropathy, Stable coronary artery disease, Lower extremity arterial disease, Low molecular weight metabolites, Functional properties of arteries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Tartu University HospitalUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- 19 Mar 2018 (actual)
- Study completion
- 19 Mar 2019
- First posted
- 7 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remote ischemic preconditioning | Experimental | Procedure: Remote ischemic preconditioningRemote 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. |
| SHAM remote ischemic preconditioning | Sham comparator | Procedure: SHAM Remote ischemic preconditioningSHAM 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (15 listed)
- 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))
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote ischemic preconditioningRemote 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. | Procedure or surgery | Remote ischemic preconditioning |
| SHAM Remote ischemic preconditioningSHAM 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 | Procedure or surgery | SHAM remote ischemic preconditioning |
Primary outcome
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.
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.
13 secondary outcomes
Cardiac markers
Time frame: 24 hours
Traditional biomarkers of renal function
Time frame: 24 hours
Novel biomarkers of renal function
Time frame: 24 hours
Estimated glomerular filtration rate
Time frame: 24 hours
Markers of oxidative stress and inflammation
Time frame: 24 hours
Length of hospital stay
Time frame: 30 days
Adverse events of angiographic procedures
Time frame: 7 days
All-cause and cardiovascular mortality
Time frame: 1 year
Adverse events associated with femoral artery puncture
Time frame: 24 hours
Cardiac event
Time frame: 30 days
Adverse events of remote ischemic preconditioning
Time frame: 10 days
Low molecular weight metabolites
Time frame: 24 hours
Arterial elasticity indices
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2018.
- Derived from this study: PubMed 36645250Liang 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaan Eha, MD, PhD study chair
Tartu University Hospital
Jaak Kals, MD, PhD principal investigator
Tartu University Hospital
Mihkel Zilmer, MD, PhD study chair
University of Tartu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote ischemic preconditioning in people with Atherosclerosis and Stable Angina, run by Tartu University Hospital at 1 site in Estonia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Estonia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in carotid-femoral pulse wave velocity compared with baseline and SHAM subgroup (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02700958, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2018.