[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100376584":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":16,"centralContacts":20,"locations":28,"responsibleParty":132,"collaborators":134,"id":146,"slug":147,"hasResults":148,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":152,"eligibilityCriteria":153,"healthyVolunteers":148,"sex":154,"minAge":155,"maxAge":7,"enrollmentInfo":156,"targetDuration":7,"studyType":159,"phases":7,"briefSummary":160,"conditions":161,"keywords":164,"overallStatus":31,"whyStopped":7,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":175},{"fullName":5,"class":6},"Rijnstate Hospital","OTHER",null,[9,13],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":7},"DIAGNOSTIC_TEST","Carotid Artery Reactivity test (CAR test)","The CAR test will be applied to stimulate the sympathetic nervous system. This thermal stimulus is known to elevate blood pressure via sympathetic pathways, so it can be used to study the vascular response to sympathetic activation. The participant will submerge their left hand in a bucket of ice water (approximately 4 degrees celcius) for 3 minutes, which is reported to be sufficient to induce a maximal dilation in the common carotid artery. At baseline and every minute after the hand is submerged in ice water, the blood pressure will be measured to check whether a sympathetic stimulation is achieved.",{"type":10,"name":14,"description":15,"armGroupLabels":7,"otherNames":7},"Arterial Stiffness","The SphygmoCor device will be used to non-invasively measure arterial stiffness parameters using applanation tonometry. For Pulse Wave Analyses (PWA), the radial waveform will be recorded. Approximately 10 waveforms are averaged, resulting in several non-invasive parameters:\n\n* Peripheral pressure parameters\n* Central and abdominal aneurysm pressure parameters (derived using a transfer function)\n* Cardiac output parameters (sub-endocardial viability ratio (SEVR), Ejection Duration (ED))\n\nPulse wave velocity will be performed by recording the waveforms of the carotid and femoral artery sequentially. The travelled distance will be measured according to the current guidelines and entered in the program. The program will calculate the PWV based on 10 ECG triggered waveform of each artery.",[17],{"name":18,"affiliation":5,"role":19},"Michel Reijnen, MD, prof","PRINCIPAL_INVESTIGATOR",[21,25],{"name":18,"role":22,"phone":23,"phoneExt":7,"email":24},"CONTACT","0880057282","MReijnen@rijnstate.nl",{"name":26,"role":22,"phone":23,"phoneExt":7,"email":27},"Jenske Vermeulen, MSc.","JVermeulen@rijnstate.nl",[29,50,63,78,90,102,117],{"facility":30,"status":31,"city":32,"state":33,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Radboudumc","RECRUITING","Nijmegen","Gelderland","6525GA","Netherlands","NL",{"type":38,"coordinates":39},"Point",[40,41],5.85278,51.8425,{"lat":41,"lon":40},[44,48],{"name":45,"role":22,"phone":46,"phoneExt":7,"email":47},"Dick Thijssen, Prof","+31 (0)24-361 42 09","Dick.Thijssen@radboudumc.nl",{"name":26,"role":22,"phone":46,"phoneExt":7,"email":49},"Jenske.Vermeulen@radboudumc.nl",{"facility":51,"status":31,"city":32,"state":33,"zip":52,"country":35,"countryCode":36,"cosmosGeoPoint":53,"geoPoint":55,"contacts":56},"Canisius Wilhelmina Ziekenhuis","6532SZ",{"type":38,"coordinates":54},[40,41],{"lat":41,"lon":40},[57,60],{"name":58,"role":22,"phone":7,"phoneExt":7,"email":59},"Bianca Bendermacher, MD","B.Bendermacher@cwz.nl",{"name":61,"role":22,"phone":7,"phoneExt":7,"email":62},"Manon Bindels","M.Bindels@cwz.nl",{"facility":64,"status":31,"city":65,"state":7,"zip":7,"country":35,"countryCode":36,"cosmosGeoPoint":66,"geoPoint":70,"contacts":71},"Gelre Hospitals","Apeldoorn",{"type":38,"coordinates":67},[68,69],5.96944,52.21,{"lat":69,"lon":68},[72,75],{"name":73,"role":22,"phone":7,"phoneExt":7,"email":74},"Hessel Buscher","h.buscher@gelre.nl",{"name":76,"role":22,"phone":7,"phoneExt":7,"email":77},"Franka de Valk","Franka.de.Valk@gelre.nl",{"facility":79,"status":31,"city":80,"state":7,"zip":7,"country":35,"countryCode":36,"cosmosGeoPoint":81,"geoPoint":85,"contacts":86},"Deventer Hospital","Deventer",{"type":38,"coordinates":82},[83,84],6.16389,52.255,{"lat":84,"lon":83},[87],{"name":88,"role":22,"phone":7,"phoneExt":7,"email":89},"Lieuwe van der Hem","L.vanderHem@dz.nl",{"facility":91,"status":31,"city":92,"state":7,"zip":7,"country":35,"countryCode":36,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"Ziekenhuis Gelderse Vallei","Ede",{"type":38,"coordinates":94},[95,96],5.65833,52.03333,{"lat":96,"lon":95},[99],{"name":100,"role":22,"phone":7,"phoneExt":7,"email":101},"Hans Sybrandy","SybrandyH@zgv.nl",{"facility":103,"status":31,"city":104,"state":7,"zip":7,"country":35,"countryCode":36,"cosmosGeoPoint":105,"geoPoint":109,"contacts":110},"Medisch Spectrum Twente","Enschede",{"type":38,"coordinates":106},[107,108],6.89583,52.21833,{"lat":108,"lon":107},[111,114],{"name":112,"role":22,"phone":7,"phoneExt":7,"email":113},"Theo Menting","Theo.Menting@mst.nl",{"name":115,"role":22,"phone":7,"phoneExt":7,"email":116},"Anja Stam","Researchbureau.Heelkunde@mst.nl",{"facility":118,"status":31,"city":119,"state":7,"zip":7,"country":35,"countryCode":36,"cosmosGeoPoint":120,"geoPoint":124,"contacts":125},"Maxima Medical Center","Veldhoven",{"type":38,"coordinates":121},[122,123],5.40278,51.41833,{"lat":123,"lon":122},[126,129],{"name":127,"role":22,"phone":7,"phoneExt":7,"email":128},"Maarten Loos","Maarten.Loos@mmc.nl",{"name":130,"role":22,"phone":7,"phoneExt":7,"email":131},"Margot Heijmans","Margot.Heijmans@mmc.nl",{"type":133,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR",[135,137,139,141,142,144,145],{"name":136,"class":6},"Radboud University Medical Center",{"name":138,"class":6},"Canisius-Wilhelmina Hospital",{"name":140,"class":6},"Gelderse Vallei Hospital",{"name":103,"class":6},{"name":143,"class":6},"Deventer Ziekenhuis",{"name":64,"class":6},{"name":118,"class":6},"100376584","tonometry1-and-duplex-ultrasound2-to-predict-cv-events-in-to-be-treated-patients-with-an-aaa-100376584",false,"NCT04183426","Tonometry(1) and Duplex Ultrasound(2) to Predict CV Events in to be Treated Patients With an AAA","Tonometry(1) and Duplex Ultrasound(2) to Predict Cardiovascular Events in to be Treated Patients With an Abdominal Aortic Aneurysm (One-Two-Treat Trial)","One-Two-Treat","Inclusion Criteria:\n\n* Male or female at least 18 years old;\n* Informed consent form understood and signed and patient agrees to follow- up visits;\n* Has an infrarenal or juxtarenal abdominal aortic aneurysm (AAA), scheduled for elective repair (i.e open repair, EVAR, FEVAR and CHEVAR) according to standard practice;\n\nExclusion Criteria:\n\n* Life expectancy \\\u003C 2 years;\n* Psychiatric or other condition that may interfere with the study;\n* Participating in another clinical study, interfering on outcomes;\n* Increased risk for coronary spasms (score Rose-questionnaire ≥2;\n* Presence of Raynaud's phenomenon, Marfan syndrome, chronic pain syndrome at upper extremity(s), presence of an AV fistula or shunt, open wounds to the upper extremity(s), and\u002For scleroderma associated with placing the hand in ice water;\n* Recent (\\\u003C3 months) presence of angina pectoris, myocardial infarction, cerebral infarction, and\u002For heart failure, or PAD treatment.","ALL","18 Years",{"count":157,"type":158},194,"ESTIMATED","OBSERVATIONAL","Abdominal aortic aneurysm (AAA) is a common vascular disease and associated with risk of rupture, but also with a high cardiovascular (CV) event rate. A key difficulty in AAA is predicting these life-threatening complications, which are strongly linked to vascular health. In 2013, the SMART risk score was developed to calculate the risk of the patients for recurrent vascular events based on clinical characteristics. Recently, a novel, easy to perform, non-invasive test of endothelial function (the carotid artery reactivity (CAR) test), reflecting target organ damage, has been introduced. The CAR is a simple, quick (5-min), non-invasive test that uses ultrasound to examine the carotid artery in response to sympathetic stimulation by placing one hand in cold water. This test shows strong agreement with both coronary and aortic responses to sympathetic stimulation and predicted CV-events in patients with peripheral arterial disease.\n\nThe aim of this prospective 2-year follow-up study is to investigate the predictive capacity of the CAR-test for development of CV-events after elective AAA repair in comparison to the SMART risk score. Secondary objectives are to investigate the predictive capacity of arterial stiffness measurements and the post-operative CAR-test for development of CV-events and to evaluate health status scores to provide insight if these scores can support clinical decision making.",[162,163],"Abdominal Aortic Aneurysm","Cardiovascular Events",[165,162,163],"Functional Response","2025-03-03",{"date":168,"type":169},"2025-03-06","ACTUAL",{"date":171,"type":169},"2020-06-12",{"date":173,"type":158},"2027-06",{"name":5,"class":6},7]