[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100550136":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":50,"centralContacts":54,"locations":63,"responsibleParty":87,"collaborators":89,"id":92,"slug":93,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":10,"eligibilityCriteria":98,"healthyVolunteers":99,"sex":100,"minAge":101,"maxAge":102,"enrollmentInfo":103,"targetDuration":10,"studyType":106,"phases":10,"briefSummary":107,"conditions":108,"keywords":10,"overallStatus":65,"whyStopped":10,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"Craig Hospital","OTHER",[8,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Spinal Cord Injury",null,"Men and women of all races, ethnic backgrounds, over the age of 18 years: adults with chronic (\\>12 months), motor complete (AIS A\u002FB) SCI with paraplegia (neurological level of injury \\[NLI\\] at T2 or below).",[13,14,15,16,17,18],"Procedure: Brachial intra-arterial infusion of vasoactive and antioxidant drugs (acetylcholine, nitroprusside, ascorbic acid)","Procedure: venous occlusion plethysmography","Drug: Acetylcholine","Drug: Sodium Nitroprusside","Drug: Ascorbic acid","Procedure: venous phlebotomy",{"label":20,"type":10,"description":21,"interventionNames":22},"Control (Non-Spinal Cord Injury)","Non-injured men and women of all races, ethnic backgrounds, over the age of 18 years.",[13,14,15,16,17,18],[24,29,33,38,42,46],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":10},"PROCEDURE","Brachial intra-arterial infusion of vasoactive and antioxidant drugs (acetylcholine, nitroprusside, ascorbic acid)","The brachial artery in the non-dominant arm will be catheterized to infuse endothelium-dependent vasodilator acetylcholine, endothelium-independent vasodilator nitroprusside, and antioxidant ascorbic acid at concentrations to have isolated effect in the forearm.",[20,9],{"type":25,"name":30,"description":31,"armGroupLabels":32,"otherNames":10},"venous occlusion plethysmography","Whole forearm blood flow will be measured by mercury-strain gauge while venous occlusion is applied to the forearm and hand by rapid-cuff inflation to sub-arterial pressures. Changes in whole forearm blood flow with be measured at baseline, endothelial agonists, and removal of oxidative stress via acorbic acid.",[20,9],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":10},"DRUG","Acetylcholine","Endothelium-dependent vasodilation will then be assessed by changes in FBF in response to intra-arterial infusions of the endothelial agonist acetylcholine infused at rates of 4.0, 8.0, 16.0 μg\u002F100 mL of forearm tissue\u002Fmin to generate a dose-response curve.",[20,9],{"type":34,"name":39,"description":40,"armGroupLabels":41,"otherNames":10},"Sodium Nitroprusside","Endothelium-independent vasodilation will be assessed by changes in forearm blood flow in response to intra-arterial infusions of sodium nitroprusside at 1.0, 2.0, 4.0 μg\u002F100 mL forearm tissue\u002Fmin.",[20,9],{"type":34,"name":43,"description":44,"armGroupLabels":45,"otherNames":10},"Ascorbic acid","Ascorbic acid will be infused at a constant rate (12 mg\u002F100 mL tissue\u002Fmin) and maintained at the same rate while the acetylcholine and sodium nitroprusside dose-response curves are repeated.",[20,9],{"type":25,"name":47,"description":48,"armGroupLabels":49,"otherNames":10},"venous phlebotomy","Venous blood samples will be collected to measure baseline cardiometabolic characteristics and isolate endothelial cell microvesicles for characterizations and in vitro experiments.",[20,9],[51],{"name":52,"affiliation":5,"role":53},"Andrew Park, MD","PRINCIPAL_INVESTIGATOR",[55,60],{"name":56,"role":57,"phone":58,"phoneExt":10,"email":59},"Clare Morey, SLP-CCC","CONTACT","303-789-8621","cmorey@craighospital.org",{"name":52,"role":57,"phone":61,"phoneExt":10,"email":62},"303-789-8101","apark@craighospital.org",[64],{"facility":5,"status":65,"city":66,"state":67,"zip":68,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":76,"contacts":77},"RECRUITING","Englewood","Colorado","80113","United States","US",{"type":72,"coordinates":73},"Point",[74,75],-104.98776,39.64777,{"lat":75,"lon":74},[78,79,82,83,85],{"name":56,"role":57,"phone":58,"phoneExt":10,"email":59},{"name":80,"role":57,"phone":10,"phoneExt":10,"email":81},"Genevieve Quintero, B.S.","gquintero@craighospital.org",{"name":52,"role":53,"phone":10,"phoneExt":10,"email":10},{"name":84,"role":53,"phone":10,"phoneExt":10,"email":10},"Christopher DeSouza, PhD",{"name":86,"role":53,"phone":10,"phoneExt":10,"email":10},"Brian Stauffer, MD",{"type":88,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[90],{"name":91,"class":6},"University of Colorado, Boulder","100550136","role-of-endothelial-function-in-sci-cvd-risk-100550136",false,"NCT06443151","Role of Endothelial Function in SCI CVD Risk","Role of Vascular Endothelial Function After Spinal Cord Injury Related Cardiovascular Disease Risk","Inclusion Criteria:\n\n* Men and women of all races, ethnic backgrounds\\>18 years of age\n* Traumatic spinal cord injury (Sports, Assault, Transport, Fall, Other Traumatic Causes)\n* Time since injury (\\> 12 months)\n* Paraplegia Motor Complete Injury (neurological level of injury at T2 or below, ASIA Impairment Scale A or B\n\nExclusion Criteria:\n\n* History of high blood pressure\n* History cardiovascular disease (coronary artery disease, congestive heart failure, myocardial infarction, cerebrovascular accident).\n* History high cholesterol\n* History of Diabetes Type I or Type II\n* History of Obstructive Pulmonary Disease\n* History of Chronic Kidney or Liver Disease\n* History of Cancer\n* History of Autoimmune Disease (Thyroid Disease, Lupus, Rheumatoid Arthritis, etc).\n* History of smoking tobacco in the last 12 months\n* History of alcohol use",true,"ALL","18 Years","89 Years",{"count":104,"type":105},60,"ESTIMATED","OBSERVATIONAL","Individuals with spinal cord injury have heart attacks and strokes more frequently, and much earlier in life. People with spinal cord injuries develop plaque in vessels much faster, and the reasons why are unclear. Doctors generally attributed the increased risk with weight gain and developing diabetes, but many studies have shown that even without these common factors, plaque in vessels is developing more often and faster. Endothelial cells are a single layer of cells that line all vessels in the body and plays an important role in vessel health. Damage to endothelial cells is known to lead to heart attacks and strokes. Past studies on endothelial cells of people with spinal cord injury have been unclear. The investigators have new data that these cells are unhealthy after spinal cord injury a measurement. This includes measuring endothelial health by directly altering its function using a catheter in the arm and measuring small particles in blood called endothelial microvesicles. If the project is successful, the investigators will learn important information on the health of endothelial cells after spinal cord injury. The investigators will also be able to use these markers of endothelial cell function to create treatments to improve vessel health and prevent heart attacks and strokes later in life in people with spinal cord injury.",[109,110,111],"Spinal Cord Injuries","Cardiovascular Diseases","Endothelial Dysfunction","2024-08-19",{"date":114,"type":115},"2024-08-20","ACTUAL",{"date":117,"type":105},"2024-09-01",{"date":119,"type":105},"2027-03-30",{"name":5,"class":6},1]