Wide Coverage GSI Cardiac Data Collection
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Evaluable GSI Cardiac Raw Scans
研究概览
简要总结
The goal of this clinical data collection study is to collect raw CT scan data using a new GSI Cardiac mode on GE HealthCare's Revolution Apex CT system.
Two groups of participants will be enrolled:
A) Participants scheduled to undergo a Coronary CT Angiography (CCTA) as part of their standard of care
B) Participants scheduled to undergo a cardiac catheterization or have a history of heart attack
Participants in Group A will:
-Have a standard of care CCTA immediately followed by a research GSI Cardiac scan
Participants in Group B will:
-Have a research CCTA immediately followed by a research GSI Cardiac scan
Both groups will be in the study for approximately 1 day. There are no follow-up visits after the day of scan.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects may be included in this study if they meet the following criteria:
- •Who are ≥18 years of age;
- •Able to sign and date the informed consent form; AND,
- •Cohort A: Undergoing a scheduled clinically indicated CCTA; OR,
- •Cohort B: Known history of myocardial infarction or undergoing a clinically indicated cardiac catheterization due to known pathology.
排除标准
- •Subjects may be excluded from participating in study if they meet any of the following criteria:
- •Who are pregnant or lactating;
- •Who were previously enrolled in this study;
- •Anyone with known or suspected allergy to iodinated contrast agents;
- •Anyone with known or suspected renal insufficiency as determined by site medical personnel;
- •Who are in need of urgent or emergent care;
- •Who have any conditions that, in the opinion of the PI or designee, would interfere with the evaluation of the results or constitute a health hazard for the subject;
- •Who are unwilling to have GEHC personnel present for the CT exam; AND,
- •Cohort A: Undergoing a scheduled clinically indicated CCTA for anatomy assessment (aberrant origin, etc.)
研究组 & 干预措施
Cohort A
Undergoing a standard of care CCTA
干预措施: GSI Cardiac Scan (Device)
Cohort A
Undergoing a standard of care CCTA
干预措施: Standard of Care CCTA (Other)
Cohort B
Known history of heart attack (myocardial infarction) or undergoing a standard of care cardiac catheterization due to known disease
干预措施: GSI Cardiac Scan (Device)
Cohort B
Known history of heart attack (myocardial infarction) or undergoing a standard of care cardiac catheterization due to known disease
干预措施: Research CCTA (Other)
结局指标
主要结局
Evaluable GSI Cardiac Raw Scans
时间窗: 12 months
Number of participants whose GSI Cardiac scan is deemed evaluable (i.e., no issues with participant motion or contrast administration and/or timing).
次要结局
- Safety Assessment(12 months)