Intracardiac Flow Assessment in Cardiac Amyloidosis
Study Details
Study Description
Brief Summary
The primary objective of this study is to define the intracardiac flow imaging biomarkers in cardiac amyloidosis.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Transthyretin (ATTR) cardiac amyloidosis Subjects diagnosed with ATTR cardiac amyloidosis will have CMR, TTE, and 6-minute walk |
Diagnostic Test: Cardiac magnetic resonance image (CMR)
A magnetic resonance imaging study for assessment of cardiac structure and intracardiac flow
Diagnostic Test: Transthoracic Echocardiogram (TTE)
An imaging test that uses soundwaves that cannot be heard (ultrasound) to take pictures of the heart and vessels.
Diagnostic Test: Six-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
|
| Light chain amyloidosis (AL) with cardiac involvement Subjects diagnosed with AL with cardiac involvement will have CMR, TTE, and 6-minute walk |
Diagnostic Test: Cardiac magnetic resonance image (CMR)
A magnetic resonance imaging study for assessment of cardiac structure and intracardiac flow
Diagnostic Test: Transthoracic Echocardiogram (TTE)
An imaging test that uses soundwaves that cannot be heard (ultrasound) to take pictures of the heart and vessels.
Diagnostic Test: Six-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
|
| Light chain amyloidosis (AL) without cardiac involvement Subjects diagnosed with AL without cardiac involvement will have CMR, TTE, and 6-minute walk |
Diagnostic Test: Cardiac magnetic resonance image (CMR)
A magnetic resonance imaging study for assessment of cardiac structure and intracardiac flow
Diagnostic Test: Transthoracic Echocardiogram (TTE)
An imaging test that uses soundwaves that cannot be heard (ultrasound) to take pictures of the heart and vessels.
Diagnostic Test: Six-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
|
| Healthy Control Subjects without history of cardiovascular diseases will have CMR, TTE, and 6-minute walk |
Diagnostic Test: Cardiac magnetic resonance image (CMR)
A magnetic resonance imaging study for assessment of cardiac structure and intracardiac flow
Diagnostic Test: Transthoracic Echocardiogram (TTE)
An imaging test that uses soundwaves that cannot be heard (ultrasound) to take pictures of the heart and vessels.
Diagnostic Test: Six-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
|
Outcome Measures
Primary Outcome Measures
- Define the intracardiac flow imaging biomarkers in cardiac amyloidosis (CA) [Baseline]
Measured by cardiac magnetic resonance imaging (CMR)
Eligibility Criteria
Criteria
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.
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Currently in sinus rhythm by clinical assessment or documented electrocardiographic studies.
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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 two 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 two years prior to study screening; Histopathologic diagnosis of amyloidosis with AL protein identification by mass spectrometry or immuno-histochemistry; 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 two years prior to study screening; Histopathologic diagnosis of amyloidosis with AL protein identification by mass spectrometry or immuno-histochemistry; 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.
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Unable to ambulate for 6 minutes (confirmed at study coordinator visit).
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Unable to maintain in supine position for 30 minutes.
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Unable to maintain breath-holding for 10 seconds (confirmed at study coordinator visit).
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Contraindications for safe CMR scanning (e.g., claustrophobia, cochlear implant, implanted neural stimulator).
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Presence of implantable cardiac pacemaker, defibrillator or recorder.
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History of intracardiac prosthesis, congenital heart disease, intracardiac shunt, prior intrathoracic surgery, or procedures to the thoracic aorta or pulmonary arteries.
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Significant artifact from prior MRI studies.
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Pregnant or breast-feeding women.
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Weight equal to or greater than 155 kg.
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Maximum body side-to-side or anterior-posterior diameter equal to or greater than 70 cm.
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Documented non-sinus rhythm within 6 months prior to screening.
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For healthy controls, the following exclusion criteria apply, confirmed per chart review and/or patient report:
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History of cardiomyopathy or structural heart disease;
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History of valvular disease of greater than mild severity;
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History of coronary artery disease or coronary heart disease;
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History of cardiac or thoracic surgery.
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History of atrial tachyarrhythmia, ventricular tachyarrhythmia, or symptomatic bradyarrhythmia;
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Left ventricular hypertrophy or abnormally increased myocardial thickness by prior echocardiography, cardiac computed tomography, or CMR;
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Acute kidney injury, OR chronic renal disease with glomerular filtration rate < 60 mL/min/1.73m^2 as per medical record review.
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Uncontrolled hypertension of systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg as per medical record review;
-
Taking two or more anti-hypertensive medications;
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Type 1 diabetes, OR uncontrolled type 2 diabetes mellitus of hemoglobin A1c greater than 7, as per medical record review;
-
Taking two or more diabetic medications;
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History of stroke or transient ischemic attack;
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Current cigarette smoker;
-
History of peripheral artery disease of aortopathy;
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History of plasma cell dyscrasia or chronic hematologic diagnosis;
-
BMI > 35 kg/m^2.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mayo Clinic | Rochester | Minnesota | United States | 55905 |
Sponsors and Collaborators
- Mayo Clinic
Investigators
- Principal Investigator: Ian C Chang, MD, Mayo Clinic
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 22-001098