Cardiovascular Risk Markers in Veterans With PTSD
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Recruitment methods feasibility
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 28 Years 至 38 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •OEF/OIF veterans at the VASDHS
- •Between 28 and 38 years of age
- •Willing to complete structured diagnostic interview for PTSD, CIMT ultrasound and blood test
- •Willing to have a review of their medical records
- •Able to give informed consent
- •Have a negative urine pregnancy test, if a woman of child-bearing age
排除标准
- •Do not meet inclusion criteria
- •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
- •Inability to complete study tests within 18 months of study start
- •Pregnancy
结局指标
主要结局
Recruitment methods feasibility
时间窗: 12 months
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.
Completion of structured diagnostic interview within 2hrs.
时间窗: 12 months
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.
Ability to schedule Carotid Intima-Media Thickness (CIMT) ultrasound in the Vascular Lab at VA San Diego Healthcare Systems, within 4 months of enrollment
时间窗: 18months
Determining whether the Vascular Lab has the capacity for a larger clinical study will be informative in planning larger prospective studies.
Time from CIMT completion to completion of clinical read.
时间窗: 18months
Rate of clinical read will help in determining adequate staffing requirements for a larger study.
Completion of serum lab measurements.
时间窗: 18months
次要结局
- Carotid Intimal Medial Thickness (CIMT) measurement(Within 4 months of subject recruitment)
- Cardiovascular Disease Biomarkers(Within 6 months of subject recruitment)