Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2026-03-04 @ 2:58 PM
Study NCT ID:
NCT01650220
Status:
TERMINATED
Last Update Posted:
2013-04-29
First Post:
2012-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiovascular Risk Markers in Veterans With Post Traumatic Stress Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'For the assessment of CVD risk, high-sensitivity CRP (hs-CRP) measurements will be used. Standard assays detect 1,000 fold increases in CRP in response to infection or inflammation; these high levels cannot be used to stratify with respect to CVD risk. Hs-CRP, however, measurement can detect CRP levels as low as 0.5 mg/L. Though mainly used for research purposes, high-sensitivity IL-6 assays are also able to discriminate IL-6 levels within the normal range for CVD risk stratification. Both CRP and IL-6 levels will be analyzed as continuous quantitative traits.\n\nThough no DNA analysis is planned for this study, subjects are asked if they are willing to have their samples banked for future research.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'whyStopped': 'The funding agency, DoD, determined that the study could not meet its enrollment numbers by the end of the grant', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-25', 'studyFirstSubmitDate': '2012-06-20', 'studyFirstSubmitQcDate': '2012-07-23', 'lastUpdatePostDateStruct': {'date': '2013-04-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recruitment methods feasibility', 'timeFrame': '12 months', 'description': 'Comparison of the number of participants per month recruited from medical providers (with/without PTSD) vs. response to recruitment fliers (with/without PTSD) in the first 12 months of the study. Selection bias to be determined by looking at differences in age and co-morbid illnesses.'}, {'measure': 'Completion of structured diagnostic interview within 2hrs.', 'timeFrame': '12 months', 'description': 'Completion of Clinician Assessed PTSD Scale (CAPS), Alcohol Use Disorders Identification Test-Consumption (AUDIT-C), Patient Health Questionnaire-9 (PHQ-9), Pittsburgh Sleep Quality Index (PSQI), INTRuST Uniformed Data Set, and Family History of heart disease, within 2hrs.'}, {'measure': 'Ability to schedule Carotid Intima-Media Thickness (CIMT) ultrasound in the Vascular Lab at VA San Diego Healthcare Systems, within 4 months of enrollment', 'timeFrame': '18months', 'description': 'Determining whether the Vascular Lab has the capacity for a larger clinical study will be informative in planning larger prospective studies.'}, {'measure': 'Time from CIMT completion to completion of clinical read.', 'timeFrame': '18months', 'description': 'Rate of clinical read will help in determining adequate staffing requirements for a larger study.'}, {'measure': 'Completion of serum lab measurements.', 'timeFrame': '18months'}], 'secondaryOutcomes': [{'measure': 'Carotid Intimal Medial Thickness (CIMT) measurement', 'timeFrame': 'Within 4 months of subject recruitment', 'description': 'CIMT thickness will be measured by carotid ultrasound'}, {'measure': 'Cardiovascular Disease Biomarkers', 'timeFrame': 'Within 6 months of subject recruitment', 'description': 'Serum C-reactive protein and interleukin-6 will be measured'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Cardiovascular Disease', 'Post Traumatic Stress Disorder']}, 'descriptionModule': {'briefSummary': 'This is an observational study designed to determine whether veterans with PTSD have a higher risk of heart disease than those without PTSD. Cardiovascular risk will be assessed by interview and review of medical records, carotid artery ultrasound, and blood tests measuring markers of inflammation. Study participation is approximately 6 months. The eligible study population is veterans of Operation Iraqi Freedom (OIF) and Operation Enduring Freedom (OEF), age 28 through 38 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '38 Years', 'minimumAge': '28 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'OIF and OEF veterans within the VASDHS, who are between 28 and 38 years of age inclusively', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* OEF/OIF veterans at the VASDHS\n* Between 28 and 38 years of age\n* Willing to complete structured diagnostic interview for PTSD, CIMT ultrasound and blood test\n* Willing to have a review of their medical records\n* Able to give informed consent\n* Have a negative urine pregnancy test, if a woman of child-bearing age\n\nExclusion Criteria:\n\n* Do not meet inclusion criteria\n* History of schizophrenia, other neurocognitive illness (including severe TBI by INTRuST criteria)) or active alcohol and/or drug abuse determined by chart review, interview or AUDIT-C score\n* Inability to complete study tests within 18 months of study start\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT01650220', 'acronym': 'CVMarkers', 'briefTitle': 'Cardiovascular Risk Markers in Veterans With Post Traumatic Stress Disorder', 'organization': {'class': 'OTHER', 'fullName': 'INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium'}, 'officialTitle': 'Cardiovascular Risk Markers in Veterans With PTSD', 'orgStudyIdInfo': {'id': 'INTRuST-CV Markers'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Veterans with a history of PTSD'}, {'label': 'Veterans without a history of PTSD'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92161', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'VASDHS', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}], 'overallOfficials': [{'name': 'Vibha Bhatnagar, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Diego'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium', 'class': 'OTHER'}, 'collaborators': [{'name': 'U.S. Army Medical Research and Development Command', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}