Intracardiac Flow Assessment in Cardiac Amyloidosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 81
- 试验地点
- 2
- 主要终点
- Define the intracardiac flow imaging biomarkers in cardiac amyloidosis (CA)
研究概览
简要总结
The primary objective of this study is to define the intracardiac flow imaging biomarkers in cardiac amyloidosis.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is clinically stable without cardio-vascular-related hospitalizations within 6 weeks prior to enrollment as assessed by the investigators.
- •Subject is able to provide written informed consent and is willing and able to complete study procedures.
- •Currently in sinus rhythm by clinical assessment or documented electrocardiographic studies.
- •Subject and disease characteristics noted by medical record review:
- •Healthy control volunteers must also meet the following criteria: Karnofsky performance scale > 80%; ECOG status 0 or
- •ATTR cardiac amyloidosis based on meeting all the following criteria: Diagnosis of amyloidosis within five years prior to study screening; Documentation of absence of AL, heavy chain disease, multiple myeloma or malignant lymphoproliferative disorders; Transthyretin amyloid deposits in cardiac tissue OR technetium (99mTc) pyrophosphate scintigraphy with grade 2 or 3 cardiac uptake OR Transthyretin amyloid deposits in non-cardiac tissue with echocardiographic evidence of cardiac involvement or an end-diastolic mean wall thickness >12mm OR Transthyretin amyloid deposits in non-cardiac tissue with CMR diagnostic of amyloidosis
- •AL with cardiac involvement based on meeting all the following criteria: Diagnosis of amyloidosis within five years prior to study screening; Histopathologic diagnosis of amyloidosis with AL protein identification; Documented clinical signs or symptoms consistent with heart failure; Cardiac involvement as defined by: Amyloid deposits in cardiac deposits OR Echocardiography with an end-diastolic mean wall thickness > 12 mm in the absence of other causes OR Elevated NT-proBNP (>332 ng/L) in the absence of renal failure or atrial fibrillation OR CMR diagnostic of amyloidosis;
- •AL without cardiac involvement based on meeting all the following criteria: Diagnosis of amyloidosis within five years prior to study screening; Histopathologic diagnosis of amyloidosis with AL protein identification; No documented clinical signs and symptoms consistent with heart failure from AL; Absence of cardiac involvement as defined by: Echocardiography with an end-diastolic mean wall thickness < 13 mm if the subject does not have other causes for increased wall thickness AND NT-proBNP <333 ng/L if the subject does not have renal failure or atrial fibrillation AND No CMR diagnostic of amyloidosis if CMR is available prior to screening.
排除标准
- •Unable to consent or unable to complete all study procedures.
- •Unable to ambulate for 6 minutes (confirmed at study coordinator visit).
- •Unable to maintain in supine position for 30 minutes.
- •Unable to maintain breath-holding for 10 seconds (confirmed at study coordinator visit).
- •Contraindications for safe CMR scanning (e.g., uncontrolled claustrophobia, cochlear implant, implanted neural stimulator).
- •Presence of implantable cardiac pacemaker or defibrillator.
- •History of complex congenital heart disease, intracardiac shunt (except for patent foramen ovale), prosthetic valves, prosthesis in the main pulmonary artery or ascending thoracic aorta.
- •Significant artifact from prior MRI studies.
- •Pregnant or breast-feeding women.
- •Weight equal to or greater than 155 kg.
- •Maximum body side-to-side or anterior-posterior diameter equal to or greater than 70 cm.
- •Documented non-sinus rhythm within 1 week prior to screening.
- •For healthy controls, the following exclusion criteria apply, confirmed per chart review and/or patient report:
- •History of cardiomyopathy or structural heart disease;
- •History of valvular disease of greater than mild severity;
- •History of coronary artery disease or coronary heart disease;
- •History of cardiac or thoracic surgery.
- •History of symptomatic, persistent atrial tachyarrhythmia, ventricular tachyarrhythmia, or bradyarrhythmia;
- •Left ventricular hypertrophy or abnormally increased myocardial thickness by prior echocardiography, cardiac computed tomography, or CMR;
- •Acute kidney injury, OR chronic renal disease with glomerular filtration rate < 45 mL/min/1.73m^2 as per medical record review.
- •Uncontrolled hypertension of systolic blood pressure > 150 mmHg or diastolic blood pressure > 90 mmHg as per medical record review;
- •Taking three or more anti-hypertensive medications;
- •Type 1 diabetes, OR uncontrolled type 2 diabetes mellitus of hemoglobin A1c greater than 8, as per medical record review;
- •Taking three or more diabetic medications;
- •History of confirmed stroke or transient ischemic attack, as per medical record review;
- •Current cigarette smoker;
- •History of plasma cell dyscrasia or chronic malignant hematologic diagnosis;
- •BMI > 35 kg/m^2.
研究组 & 干预措施
Transthyretin (ATTR) cardiac amyloidosis
Subjects diagnosed with ATTR cardiac amyloidosis will have CMR, TTE, and 6-minute walk
干预措施: Cardiac magnetic resonance image (CMR) (Diagnostic Test)
Transthyretin (ATTR) cardiac amyloidosis
Subjects diagnosed with ATTR cardiac amyloidosis will have CMR, TTE, and 6-minute walk
干预措施: Transthoracic Echocardiogram (TTE) (Diagnostic Test)
Transthyretin (ATTR) cardiac amyloidosis
Subjects diagnosed with ATTR cardiac amyloidosis will have CMR, TTE, and 6-minute walk
干预措施: Six-minute Walk Test (Diagnostic Test)
Light chain amyloidosis (AL) with cardiac involvement
Subjects diagnosed with AL with cardiac involvement will have CMR, TTE, and 6-minute walk
干预措施: Cardiac magnetic resonance image (CMR) (Diagnostic Test)
Light chain amyloidosis (AL) with cardiac involvement
Subjects diagnosed with AL with cardiac involvement will have CMR, TTE, and 6-minute walk
干预措施: Transthoracic Echocardiogram (TTE) (Diagnostic Test)
Light chain amyloidosis (AL) with cardiac involvement
Subjects diagnosed with AL with cardiac involvement will have CMR, TTE, and 6-minute walk
干预措施: Six-minute Walk Test (Diagnostic Test)
Light chain amyloidosis (AL) without cardiac involvement
Subjects diagnosed with AL without cardiac involvement will have CMR, TTE, and 6-minute walk
干预措施: Cardiac magnetic resonance image (CMR) (Diagnostic Test)
Light chain amyloidosis (AL) without cardiac involvement
Subjects diagnosed with AL without cardiac involvement will have CMR, TTE, and 6-minute walk
干预措施: Transthoracic Echocardiogram (TTE) (Diagnostic Test)
Light chain amyloidosis (AL) without cardiac involvement
Subjects diagnosed with AL without cardiac involvement will have CMR, TTE, and 6-minute walk
干预措施: Six-minute Walk Test (Diagnostic Test)
Healthy Control
Subjects without history of cardiovascular diseases will have CMR, TTE, and 6-minute walk
干预措施: Cardiac magnetic resonance image (CMR) (Diagnostic Test)
Healthy Control
Subjects without history of cardiovascular diseases will have CMR, TTE, and 6-minute walk
干预措施: Transthoracic Echocardiogram (TTE) (Diagnostic Test)
Healthy Control
Subjects without history of cardiovascular diseases will have CMR, TTE, and 6-minute walk
干预措施: Six-minute Walk Test (Diagnostic Test)
结局指标
主要结局
Define the intracardiac flow imaging biomarkers in cardiac amyloidosis (CA)
时间窗: Baseline
Measured by cardiac magnetic resonance imaging (CMR)
次要结局
未报告次要终点