DECIDE Registry: AI DErived Plaque Quantification: CCTA and AI-QCPA for Determining Effective CAD Management
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20,000
- 试验地点
- 2
- 主要终点
- Primary Endpoint
研究概览
简要总结
The objective of HeartFlow's DECIDE Registry is to collect observational data about the management of patients before and after HeartFlow Artificial Intelligence-Quantitative Coronary Plaque Analysis (AI-QCPA).
详细描述
The DECIDE Registry is a post-market, multi-center, data collection study assessing the change in management of clinically stable patients who undergo CCTA with plaque detected. Data will be retrospectively collected following the CCTA, and analyses will be completed 90 days, 180 days, and 1 year after CCTA. Data may be retrospectively collected annually up to 5 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(all must be present) :
- •Groups 1, 2,4,5 and 6: CCTA and plaque detected
- •Group 3: Any patient with a stress test (stress echocardiogram or nuclear imaging including SPECT or PET) and no CCTA within the 90 days prior to site activation
- •Groups 1,2,3 and 4: Clinically stable, symptomatic
- •Group 6: Clinically stable without symptoms suggestive of CAD at the time of the CCTA
排除标准
- •(all must be absent) :
- •ED presentation (at the time of the CCTA or stress test)
- •Groups 1,2,3,4, and 6: Previous history of CAD (prior to the CCTA or stress test with history of revascularization)
- •Group 5: Prior history of PCI in multiple vessel territories, PCI in the Left Main, CABG, and/or any other conditions or limitations which would prevent successful CCTA processing by HeartFlow
- •Acute chest pain (in patients who have not been ruled out for ACS)
- •Previously evaluated with and/or in a study which includes AI-QCPA
研究组 & 干预措施
Group 1: No AI-QCPA
This group includes previously scanned, symptomatic patients with plaque detected and no prior revascularization. No AI-QCPA will be provided.
Group 2: Delayed AI-QCPA
This group includes previously scanned, symptomatic patients with plaque detected and no prior revascularization. Ninety days following the CCTA, an AI-QCPA report will be provided to the CCTA reader who will in turn provide it to the treating clinician. The treating clinician will decide if changes to medical management are required to effectively treat the patient and if so, treating clinician will contact the patient with the new treatment plan.
干预措施: AI-enabled quantitative coronary plaque analysis (AI-QCPA) (Diagnostic Test)
Group 3: Stress Test Only
This group includes symptomatic patients who previously had non-invasive stress testing only with no CCTA and no prior revascularization. No AI-QCPA will be provided.
Group 4: Prospective AI-QCPA, symptomatic without prior revascularization
This group includes newly scanned, symptomatic patients with plaque detected and no prior revascularization. Patients in this group will have current symptoms suggestive of CAD and will not have had prior revascularization. CCTA reader who identifies plaque orders AI-QCPA to inform the medical management plan for the patient.
干预措施: AI-enabled quantitative coronary plaque analysis (AI-QCPA) (Diagnostic Test)
Group 5: Prospective AI-QCPA, prior PCI
This group includes newly scanned patients with plaque detected. Patients in this group can by symptomatic or asymptomatic and will have had prior PCI in only one vessel territory (CABG patients are not eligible). CCTA reader who identifies plaque orders AI-QCPA to inform the medical management plan for the patient.
干预措施: AI-enabled quantitative coronary plaque analysis (AI-QCPA) (Diagnostic Test)
Group 6: Prospective AI-QCPA, asymptomatic without prior revascularization
This group includes newly scanned, asymptomatic patients with plaque detected and no prior revascularization. Patients in this group will not have current symptoms suggestive of CAD and will not have had prior revascularization. CCTA reader who identifies plaque orders AI-QCPA to inform the medical management plan for the patient.
干预措施: AI-enabled quantitative coronary plaque analysis (AI-QCPA) (Diagnostic Test)
结局指标
主要结局
Primary Endpoint
时间窗: 90 Days
The primary endpoint of the DECIDE Registry is the change in medical management following HeartFlow AI-QCPA at 90 days compared to medical management following CCTA alone. The primary endpoint will only be assessed in patients in Group 2.
次要结局
- Reclassification rate of symptoms(90 Days, 180 Days and 365 Days)
- Number of CV hospitalizations(At 365 Days (and potentially out to 5 years))
- Number of Revascularizations(365 Days)
- Changes in weight(From baseline to 90 days, from 90 days to 180 days, and 90 days to 365 days)
- Reclassification rate of medical management (across the groups)(90 Days, 180 Days and 365 Days)
- Rates of referral to invasive coronary angiography and coronary revascularization (PCI+CABG)(90 Days, 180 Days and 365 Days)
- Changes in Non HDL levels(From baseline to 90 days, from 90 days to 180 days, and 90 days to 365 days)
- Changes in HDL levels(From baseline to 90 days, from 90 days to 180 days, and 90 days to 365 days)
- Changes in TG levels(From baseline to 90 days, from 90 days to 180 days, and 90 days to 365 days)
- Change in LDL levels(From baseline to 90 days, from 90 days to 180 days, and 90 days to 365 days)
- Change in HbA1c levels(From baseline to 90 days, from 90 days to 180 days, and 90 days to 365 days)