Screening For Asymptomatic Obstructive Coronary Artery Disease Among High-Risk Diabetic Patients Using CT Angiography, Following Core 64: A Randomized Control Study (The faCTor-64 Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 900
- 试验地点
- 2
- 主要终点
- Number of Participants With Combination of All Cause Death, Non-fatal Myocardial Infarction (MI), and Hospitalization for Unstable Angina
研究概览
简要总结
Patients with a known history of diabetes mellitus and no prior documented evidence of cardiovascular disease will be evaluated for inclusion in the study. Once qualified, patients will be enrolled and be randomized to either the Control Arm or to the Asymptomatic Screening Arm. Patients in the Control Arm will be followed by their primary care physicians with the recommendation that they follow standard guidelines for management of diabetic patients.
Patients in the Asymptomatic Screening Arm will undergo CT screening for either coronary calcium scoring or multi-slice CT angiography as well as be placed on one of two medical regimens. Patients will be followed by telephone at six-month intervals for a minimum of one year for both primary and secondary outcomes.
详细描述
Management of Patients Randomized to the Control Arm: Subjects randomized to the control arm will continue to be followed by their primary care physicians with the recommendation that they follow standard guidelines for management of diabetic patients.
Management of Patients Randomized to the Asymptomatic Screening Arm: Subjects randomized to the Asymptomatic Screening arm will undergo initial CT screening in the following fashion:
- Subjects with serum creatinine of < 2.0 mg/dl (men) or <1.8 mg/dL (women) will be screened using multi-slice CT angiography with contrast.
- Those with serum creatinine ≥ 2.0 mg/dl (men) or >1.8 mg/dL (women) will be screened without contrast to obtain a coronary calcium score. Further cardiac screening will be determined based on these results.
Subjects Receiving Multi-Slice CT Angiography (serum creatinine of < 2.0 mg/dl (men) or <1.8 mg/dL (women)): Subjects severe stenosis will proceed to coronary angiography and revascularization as needed. Subjects with moderate stenosis will be referred for adenosine stress cardiac MRI. If ischemia is detected, they will also be referred for coronary angiography. Subjects with either mild stenosis or normal coronary arteries will receive no further imaging studies.
Subjects Undergoing CT Evaluation for Coronary Calcium Scoring (serum creatinine ≥ 2.0 mg/dl (men) or >1.8 mg/dL (women): Subjects with coronary calcium scores >100 or >75th percentile will be referred for adenosine stress cardiac MRI. If ischemia is detected, they will be referred for coronary angiography. Subjects with coronary calcium scores = 0-10 or 11-100 and <75th percentile will receive no further imaging studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- None
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
- •Age: Males ≥ 50 years; Females ≥55 years with: History of diabetes mellitus (prior documentation of fasting glucose ≥ 126 mg/dl or hemoglobin A1C > 6.5%), either type 1 or type 2, documented for at least 3 years and on medication for at least one year.
- •Age: Males ≥ 40 years; Females ≥45 years with: History of diabetes mellitus (prior documentation of fasting glucose ≥ 126 mg/dl or hemoglobin A1C > 6.5%), either type 1 or type 2, documented for at least 5 years and on medication for at least one year.
- •The patient or legally authorized representative must sign a written informed consent, prior to the procedure, using a form that is approved by the local Institutional Review Board.
排除标准
- •Known coronary artery disease (stenosis >70%, history of myocardial infarction, or angina)
- •Symptomatic cerebral vascular disease (history of TIA, CVA, or cerebrovascular [carotid or cerebral arteries] revascularization)
- •Symptomatic peripheral vascular disease (history of claudication, amputation, or peripheral [including renal arteries] arterial revascularization)
- •Treatment with any other investigational drug within the previous 30 days
- •Any therapy or condition that would pose a risk to the patient or make it difficult to comply with study requirements.
- •Pregnant and/or lactating women, and women of child bearing potential not using acceptable means of contraception. Women of childbearing potential must be using adequate measures of contraception (as determined by the Investigator) to avoid pregnancy and should be highly unlikely to conceive during the study period. Women of childbearing potential must have a negative pregnancy test at screen.
- •Any life threatening condition/significant co-morbidity such that primary screening is inappropriate.
结局指标
主要结局
Number of Participants With Combination of All Cause Death, Non-fatal Myocardial Infarction (MI), and Hospitalization for Unstable Angina
时间窗: 4 years
次要结局
- Number of Participants Suffering Cardiovascular (CV) Death(4 years)
- Number of Participants With Limb Amputation or Peripheral Vascular Revascularization Procedure(4 years)
- Number of Participants With Combination of Coronary Death, Non-fatal MI, and Unstable Angina With Hospitalization(4 years)
- Number of Participants With Stroke or Carotid Revascularization Procedure(4 years)
- Number of Participants With Hospitalization for Heart Failure(4 years)