Amyloidosis Cardiac, Healthy Adults
Conditions
Brief summary
The primary objective of this study is to define the intracardiac flow imaging biomarkers in cardiac amyloidosis.
Interventions
DIAGNOSTIC_TESTCardiac magnetic resonance image (CMR)
A magnetic resonance imaging study for assessment of cardiac structure and intracardiac flow
DIAGNOSTIC_TESTTransthoracic Echocardiogram (TTE)
An imaging test that uses soundwaves that cannot be heard (ultrasound) to take pictures of the heart and vessels.
DIAGNOSTIC_TESTSix-minute Walk Test
A self-paced, test of exercise capacity performed unencouraged intensity that measures the distance that patients can walk on a flat, hard surface in a period of 6 minutes
Sponsors
Mayo Clinic
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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 1. * 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Define the intracardiac flow imaging biomarkers in cardiac amyloidosis (CA) | Baseline | Measured by cardiac magnetic resonance imaging (CMR) |
Countries
United States
Contacts
Primary ContactKathy Brown
Outcome results
None listed