ATTRACT-52: Advancing TTR Testing and Risk-Based Amyloidosis Cardiac Screening in Primary Care - The Ordu Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Proportion of high-suspicion participants with elevated NT-proBNP (>600 pg/mL)
研究概览
简要总结
Cardiac amyloidosis is a progressive infiltrative cardiomyopathy, most commonly related to transthyretin (ATTR) misfolding. Although considered rare, emerging data suggest higher prevalence in specific regions, including the Black Sea area of Turkey. Early recognition improves outcomes. ATTRACT-52 is a prospective, observational, non-interventional screening study in primary care (family medicine centers) across Ordu province. Adults ≥65 years with cardiac or musculoskeletal "red flags" will be screened; those meeting high-suspicion criteria will undergo NT-proBNP/BNP testing at the primary care level to aid risk stratification prior to referral for confirmatory diagnostics.
详细描述
This study implements a risk-based screening pathway for suspected transthyretin cardiac amyloidosis (ATTR-CM) in primary care. Eligible adults (≥65 years) with relevant cardiac diagnoses (e.g., heart failure, aortic stenosis, cardiomyopathy, AV block, atrial fibrillation) and/or extracardiac red flags (e.g., carpal tunnel syndrome, spinal stenosis, trigger finger) will be reviewed against predefined criteria. When high suspicion is present, NT-proBNP (>600 pg/mL) or BNP (>150 pg/mL) will be obtained in primary care to refine risk prior to referral for confirmatory testing (e.g., bone scintigraphy, CMR) per standard care. Only high-risk patients will be tested; the number of tests will remain limited and appropriate for feasibility. Primary outcomes focus on diagnostic yield and feasibility of this first-line screening model in family medicine settings.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥65 years
- •Registered patient in participating Family Medicine Centers (Ordu province)
- •Cardiac history including at least one of: heart failure (I50), aortic stenosis (I35.0), cardiomyopathy (I42), atrioventricular block (I44), or atrial fibrillation (I48)
- •Echocardiographic interventricular septal thickness ≥12 mm with preserved LVEF (≥50%), when available
- •Ability to provide verbal or written consent
排除标准
- •Known systemic AL amyloidosis
- •Severe renal impairment (eGFR <30 mL/min/1.73m²)
- •Inability to provide consent
- •Concurrent participation in an interventional trial
研究组 & 干预措施
Risk-based Screening Cohort
Adults ≥65 years in primary care screened using predefined red flags; high-suspicion cases receive NT-proBNP/BNP testing before referral per standard care.
结局指标
主要结局
Proportion of high-suspicion participants with elevated NT-proBNP (>600 pg/mL)
时间窗: Baseline (Day 0)
Percentage of high-suspicion cases exceeding the predefined NT-proBNP threshold at baseline.
次要结局
- Confirmed cardiac amyloidosis diagnosis rate(Up to 12 months)
- Time from screening to confirmed diagnosis(Up to 12 months)
- Feasibility and physician protocol adherence(Up to 12 months)