NCT07461350Enrolling By Invitation不适用
Stimulant and Polysubstance Use, Inflammation, and Sex Effects on Myocardial Disease in HIV (SPISE)
适应症
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 400
- 试验地点
- 4
- 主要终点
- Cardiac MRI
研究概览
简要总结
This observational research study is studying how substance use impacts scarring and inflammation of the heart. This study involves one study visit for a cardiac MRI.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Participants with and without HIV enrolled in the MACS/WIHS Combined Cohort Study (MWCCS) Atlanta, Baltimore, Bronx, and San Francisco study sites
排除标准
- •Standard contraindications to MRI
- •claustrophobia,
- •metal implants,
- •large body size (weight >350 lbs or abdominal sagittal diameter >70 cm),
- •pregnancy)
- •Gadolinium risk
- •severe or uncontrolled asthma,
- •visit day eGFR<45 ml/min/1.73 m2;
- •poor venous access
- •pregnancy or lactation
研究组 & 干预措施
No Stimulant use
Never used stimulants (amphetamines, cocaine, etc.)
Current Stimulant Use
Used stimulants (amphetamines, cocaine, etc.) in past year
Past Stimulant Use
Previously used stimulants (amphetamines, cocaine, etc.) but not in the last 12 months
结局指标
主要结局
Cardiac MRI
时间窗: Visit 1, up to 2 hours
CMR assessments to provide detailed myocardial characterization (e.g. diffuse inflammation (nT1), myocardial fibrosis (ECV), and myocardial scar assessed using LGE)
次要结局
未报告次要终点
研究者
研究点 (4)
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