Prevalence of Transthyretin Cardiac Amyloidosis in Clinically Significant Aortic Stenosis: A Community Study
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Prevalence of TTR-CA in patients with moderate and severe aortic stenosis
研究概览
简要总结
The purpose of this study is to determine the prevalence of transthyretin cardiac amyloidosis (TTR-CA) among patients with moderate and severe aortic stenosis in Southeast Minnesota using 99mTc-PYP single-photon positive emission computed tomography with computed tomography (SPECT/CT).
详细描述
Residents of Southeast Minnesota over 75 years of age with an inpatient or outpatient diagnosis of moderate or severe aortic stenosis will be consecutively identified using an automated bi-weekly review of the echo lab calendar (on Mondays and Fridays) at Mayo Clinic Rochester (MCR) and Mayo Clinic Health System (MCHS) sites. Participants will be consented to undergo venipuncture, urine collection and 99mTc-PYP SPECT/CT imaging to rule in/out the diagnosis of TTR-CA. Hence, the prevalence of TTR-CA will be defined. To place this prevalence in perspective of the global aortic stenosis cohort in the community, a rigorous screening log will be maintained to allow generation of a comprehensive CONSORT diagram. Importantly, baseline characteristics of patients who qualify for our study but decline to consent will still be collected provided that consent for use of their records for medical research had previously been granted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Resident of Southeastern Minnesota (Olmsted, Dodge, Fillmore, Mower, Freeborn, Wabasha, or Steele County)
- •Age ≥ 75 years
- •Current diagnosis of moderate or severe aortic stenosis by most recent (within 6 months at most) echocardiogram as defined by:
- •Moderate AS: 1.0 cm2 < aortic valve area (AVA) ≤ 1.5 cm2
- •Severe AS: AVA ≤ 1.0 cm2
排除标准
- •Any cardiac surgery or major chest trauma within 4 weeks of PYP scan
- •Myocardial infarction within 4 weeks of PYP scan defined by typical angina, EKG changes and significant change in serial troponins. (Note that chronic troponin elevation is extremely common in cardiac amyloidosis).
- •Prior or current exposure to Plaquenil (Hydroxychloroquine)
研究组 & 干预措施
SPECT/CT
99mTc-PYP single-photon positive emission computed tomography with computed tomography
干预措施: 99mTc-PYP (Drug)
结局指标
主要结局
Prevalence of TTR-CA in patients with moderate and severe aortic stenosis
时间窗: Baseline
Determine the prevalence of Transthyretin Cardiac Amyloidosis in a community based cohort of consecutive patients with moderate or severe aortic stenosis using 99mTc-Pyrophosphate (99mTc-PYP) single-photon positive emission computed tomography with computed tomography (SPECT/CT)
次要结局
未报告次要终点
研究者
Omar Abou Ezzeddine
Principal Investigator
Mayo Clinic