Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2026-02-24 @ 3:16 PM
Study NCT ID:
NCT02700958
Status:
COMPLETED
Last Update Posted:
2018-05-17
First Post:
2016-02-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Remote Ischemic Preconditioning as a Method Against Subclinical Renal Injury and Contrast-induced Nephropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D060050', 'term': 'Angina, Stable'}, {'id': 'D058729', 'term': 'Peripheral Arterial Disease'}], 'ancestors': [{'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000787', 'term': 'Angina Pectoris'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2019-03-19'}, 'lastUpdateSubmitDate': '2018-05-16', 'studyFirstSubmitDate': '2016-02-03', 'studyFirstSubmitQcDate': '2016-03-04', 'lastUpdatePostDateStruct': {'date': '2018-05-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in carotid-femoral pulse wave velocity compared with baseline and SHAM subgroup', 'timeFrame': '24 hours', 'description': '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.'}, {'measure': 'Change in augmentation indices (augmentation index and heart rate-corrected augmentation index (AIx@75)) compared with baseline and SHAM subgroup', 'timeFrame': '24 hours', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Cardiac markers', 'timeFrame': '24 hours', 'description': 'N-terminal pro-brain natriuretic peptide (NT-proBNP), creatine kinase (CK) MB isoenzyme, troponin T'}, {'measure': 'Traditional biomarkers of renal function', 'timeFrame': '24 hours', 'description': 'Urea, creatinine'}, {'measure': 'Novel biomarkers of renal function', 'timeFrame': '24 hours', 'description': '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'}, {'measure': 'Estimated glomerular filtration rate', 'timeFrame': '24 hours', 'description': 'eGFR'}, {'measure': 'Markers of oxidative stress and inflammation', 'timeFrame': '24 hours', 'description': 'Oxidized low density lipoprotein (oxLDL), interleukin 18 (IL-18), myeloperoxidase (MPO)'}, {'measure': 'Length of hospital stay', 'timeFrame': '30 days', 'description': 'Length of hospital stay measured in days.'}, {'measure': 'Adverse events of angiographic procedures', 'timeFrame': '7 days', 'description': 'Allergic reactions to iodinated contrast media or local anesthetics'}, {'measure': 'All-cause and cardiovascular mortality', 'timeFrame': '1 year', 'description': 'Data of 1-year all-cause and cardiovascular mortality will be collected from the Estonian Causes of Death Registry.'}, {'measure': 'Adverse events associated with femoral artery puncture', 'timeFrame': '24 hours', 'description': 'Bleeding, hematoma, arterial thrombosis'}, {'measure': 'Cardiac event', 'timeFrame': '30 days', 'description': 'Myocardial infarction or cardiac arrest'}, {'measure': 'Adverse events of remote ischemic preconditioning', 'timeFrame': '10 days', 'description': 'Upper-extremity deep vein thrombosis, acute upper limb ischaemia'}, {'measure': 'Low molecular weight metabolites', 'timeFrame': '24 hours', 'description': '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.'}, {'measure': 'Arterial elasticity indices', 'timeFrame': '24 hours', 'description': '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.'}]}, 'conditionsModule': {'keywords': ['Remote ischemic preconditioning', 'Contrast-induced Nephropathy', 'Stable coronary artery disease', 'Lower extremity arterial disease', 'Low molecular weight metabolites', 'Functional properties of arteries'], 'conditions': ['Atherosclerosis', 'Stable Angina', 'Peripheral Artery Disease', 'Contrast-induced Nephropathy']}, 'referencesModule': {'references': [{'pmid': '36645250', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age greater than 18 years, no upper age limit\n* 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\n* Written informed consent\n\nExclusion Criteria:\n\n* Pregnancy\n* Age less than 18 years\n* eGFR \\< 30 ml/min/1,73 m2\n* Simultaneous participation in an other clinical trial\n* 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))\n* Malignant tumor (in remission less than 5 years or ongoing treatment)\n* Documented allergic reaction to iodinated contrast agent\n* Acute infection (body temperature 38 degrees Celsius or higher, c reactive protein 50mg/L or higher)\n* Cardiac rhythm abnormalities (atrial fibrillation, frequent supraventricular premature complexes)\n* Documented myocardial infarction within 30 days\n* Inability to understand the instructions of the study\n* Vascular surgery in axillary region\n* Unable to lie supine for 40 minutes\n* Home oxygen treatment\n* Documented upper limb deep vein thrombosis'}, 'identificationModule': {'nctId': 'NCT02700958', 'briefTitle': 'Remote Ischemic Preconditioning as a Method Against Subclinical Renal Injury and Contrast-induced Nephropathy', 'organization': {'class': 'OTHER', 'fullName': 'Tartu University Hospital'}, 'officialTitle': 'Study of Remote Ischemic Preconditioning as a Preventative Method Against Subclinical Renal Injury and Contrast-induced Nephropathy', 'orgStudyIdInfo': {'id': '16003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Remote ischemic preconditioning', 'description': '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.', 'interventionNames': ['Procedure: Remote ischemic preconditioning']}, {'type': 'SHAM_COMPARATOR', 'label': 'SHAM remote ischemic preconditioning', 'description': '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.', 'interventionNames': ['Procedure: SHAM Remote ischemic preconditioning']}], 'interventions': [{'name': 'Remote ischemic preconditioning', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['Remote ischemic preconditioning']}, {'name': 'SHAM Remote ischemic preconditioning', 'type': 'PROCEDURE', 'description': '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', 'armGroupLabels': ['SHAM remote ischemic preconditioning']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50406', 'city': 'Tartu', 'state': 'Tartu County', 'country': 'Estonia', 'facility': 'Tartu University Hospital', 'geoPoint': {'lat': 58.38062, 'lon': 26.72509}}], 'overallOfficials': [{'name': 'Jaan Eha, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Tartu University Hospital'}, {'name': 'Jaak Kals, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tartu University Hospital'}, {'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', 'affiliation': 'University of Tartu'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tartu University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Tartu University Hospital, Clinic of Surgery, Department of Vascular Surgery, cardiovascular surgeon; MD-PhD', 'investigatorFullName': 'Jaak Kals', 'investigatorAffiliation': 'Tartu University Hospital'}}}}