RECRUITING

Intracardiac Flow Assessment in Cardiac Amyloidosis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The primary objective of this study is to define the intracardiac flow imaging biomarkers in cardiac amyloidosis.

Official Title

Intracardiac Flow Assessment in Cardiac Amyloidosis

Quick Facts

Study Start:2022-07-20

Study Completion:2025-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05379101

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Kathy Brown

CONTACT

507-538-1321

brown.kathy@mayo.edu

Principal Investigator

Ian C Chang, MD

PRINCIPAL_INVESTIGATOR

Mayo Clinic

Study Locations (Sites)

Mayo Clinic

Rochester, Minnesota, 55905

United States

Collaborators and Investigators

Sponsor: Mayo Clinic

Ian C Chang, MD, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-07-20

Study Completion Date2025-06

Study Record Updates

Study Start Date2022-07-20

Study Completion Date2025-06

Terms related to this study

Additional Relevant MeSH Terms

Amyloidosis Cardiac
Healthy Adults