Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2025-12-25 @ 7:09 PM
Study NCT ID:
NCT01204632
Status:
COMPLETED
Last Update Posted:
2016-02-18
First Post:
2010-09-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cardiometabolic Risk, Obesity and Cardiovascular Disease in People With Spinal Cord Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-17', 'studyFirstSubmitDate': '2010-09-16', 'studyFirstSubmitQcDate': '2010-09-16', 'lastUpdatePostDateStruct': {'date': '2016-02-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body composition', 'timeFrame': '1 visit', 'description': "The percent of muscle and fat in each participants' body will be measured by dual x-ray absorptiometry (DEXA) scan."}], 'secondaryOutcomes': [{'measure': 'Carotid Intima-Media Thickness', 'timeFrame': '1 visit', 'description': 'Carotid intima-media thickness (IMT) measurements will be generated using B-mode external vascular ultrasound.'}, {'measure': 'Coronary Artery Calcium', 'timeFrame': '1 visit', 'description': 'Non-contrast cardiac CT will be used to measure coronary artery calcium, as the presence of any calcium detected in the coronary tree is diagnostic of atherosclerosis. The volume of calcium is quantified, providing a score of plaque burden analogous to a physiologic stress test. Coronary calcium scores directly correlate with risk of cardiac events, with higher scores indicating greater plaque burden and greater risk of cardiac events.'}, {'measure': 'Atherosclerotic plaques', 'timeFrame': '1 visit', 'description': 'Noninvasive CT angiography will be used in visualizing both calcified and non-calcified atherosclerotic plaques. This technique provides much finer anatomic detail and provides an opportunity to further identify latent atherosclerosis risk through the detection of both calcified and noncalcified atherosclerosis.'}, {'measure': 'Area Under the Curve (AUC)for lipemia', 'timeFrame': '1 visit', 'description': 'Lipemia is assessed by the AUC for triglycerides during an oral glucose tolerance test.'}, {'measure': 'Area Under the Curve (AUC) for glycemia', 'timeFrame': '1 visit', 'description': 'Glycemia is assessed by the AUC for glucose and insulin during an oral glucose tolerance test.'}, {'measure': 'Area Under the Curve (AUC)for vascular inflammation', 'timeFrame': '1 visit', 'description': 'The pro-atherogenic inflammatory mediators are AUCs for C-reactive protein and Interleukin-6 during an oral glucose tolerance test.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Spinal Cord Injury']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to develop and field-test new tools for diagnosis and hazard assessment of cardiometabolic risk (CMR) in people with chronic spinal cord injury (SCI) and to advance the evidence base with much needed information on CMR and cardiovascular disease (CVD) burden in people with SCI. These data can be used to develop screening guidelines for early identification and prevention of CMR in SCI, as well as targeted approaches to primary disease management.', 'detailedDescription': 'Unlike current assessments utilizing lipid scores, the new system will be anchored in more reliable measurements of cardiovascular disease (CVD) burden using contemporary surrogate end points of coronary artery calcium (CAC) score, coronary CT angiography and carotid intima media thickness (CIMT). By the end of the 5-year funding cycle we will develop an updatable web-based cardiometabolic risk assessment tool (RISK) that will allow clinicians and SCI consumers to quantify risk for a cardiovascular sentinel event (stroke, non-fatal heart attack, or death) and will also provide a body mass index (BMI) table adjusted for SCI.\n\nSpecific Aims:\n\n1. Examine the relationships among surrogates of cardiovascular disease burden in persons with SCI and established cardiometabolic risks.\n2. Identify significant predictors of cardiometabolic risk (CMR) that are unique to persons with specific levels of SCI.\n3. Develop and validate SCI CMR assessment tool (RISK) based on cardiometabolic risk scores.\n4. Develop and validate an adjusted BMI table for SCI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Community sample of healthy persons with spinal cord injury', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* traumatic spinal cord injury between C4 and T12\n* have a motor complete injury as classified as American Spinal Injury Association Impairment Scale (AIS) grade A or B\n* injury for more than 1 year\n* no known history of traumatic brain injury, cardiovascular disease or diabetes\n* not currently taking any medications to treat cardiovascular disease or diabetes\n* have multiple (i.e., 2+) of the following cardiometabolic risk factors:\n\n 1. fasting triglyceride \\> 150 mg/dL\n 2. HDLC \\< 40 mg/dL\n 3. hs-CRP \\> 3.0\n 4. body fat (by DEXA) \\>25% for males and 33% for females\n\nExclusion Criteria:\n\n* history of allergy or hypersensitivity to fish and/or nuts\n* undergoing anticoagulant therapies'}, 'identificationModule': {'nctId': 'NCT01204632', 'briefTitle': 'Cardiometabolic Risk, Obesity and Cardiovascular Disease in People With Spinal Cord Injury', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'Cardiometabolic Risk, Obesity and Cardiovascular Disease in People With Spinal Cord Injury', 'orgStudyIdInfo': {'id': 'TMP-MN-008'}}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'The Miami Project to Cure Paralysis', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'overallOfficials': [{'name': 'Mark S Nash, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami Miller School of Medicine, The Miami Project to Cure Paralysis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'collaborators': [{'name': 'MedStar National Rehabilitation Network', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Mark S. Nash, Ph.D., FACSM', 'investigatorAffiliation': 'University of Miami'}}}}