BridgeMD
New treatment option for Amyloidosis, Primary
Official title Molecular Imaging of Primary Amyloid Cardiomyopathy
ClinicalTrials.gov ID: NCT02641145
What this study is testing
- What it's testing
- Cardiac amyloidosis is a major cause of early treatment-related death and poor overall survival in individuals with systemic light chain amyloidosis. This project will develop a novel approach to visualize cardiac amyloid deposits using advanced imaging methods.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 99
You may be able to join if
- Age \> 18 years
- Diagnosis of light chain amyloidosis by standard criteria (immunofixation of serum and urine, IgG free light chain (FLC) assay, a biopsy of fat pad/...
- For people traveling from out of town referred for systemic AL therapy based on clinical evaluation and laboratory testing, but, pending biopsy...
- people with localized amyloid deposition and non-systemic AL disease will be eligible for enrollment in group D.
- Willing and able to provide consent
You likely can't join if
- Hemodynamic instability
- Decompensated heart failure (unable to lie flat for 1 hour)
- Concomitant non-ischemic non-amyloid heart disease (valvular heart disease or dilated cardiomyopathy)
- Known obstructive epicardial coronary artery disease with stenosis \> 50% in any single territory
- Severe claustrophobia despite use of sedatives
- Presence of MRI contraindications such as metallic implants (pacemaker or ICD) at the time of study enrollment except for Control Heart Failure...
See the full eligibility criteria
- Age \> 18 years
- Diagnosis of light chain amyloidosis by standard criteria (immunofixation of serum and urine, IgG free light chain (FLC) assay, a biopsy of fat pad/ bone marrow, or organ biopsy, followed by typing of the light chain...
- For people traveling from out of town referred for systemic AL therapy based on clinical evaluation and laboratory testing, but, pending biopsy results, study enrollment and procedures may begin before official...
- people with localized amyloid deposition and non-systemic AL disease will be eligible for enrollment in group D.
- Willing and able to provide consent
- Additional for the Remission AL-CMP: Hematological response defined as complete hematological remission or very good partial response-differential free light chain (dFLC)\ 1 year prior to enrollment
- Additional for the Active AL-CMP - exercise: Ability to perform supine bicycle exercise. Enrollment to this arm will stop after 36 people complete baseline and 6 months studies.
- Additional for the Active AL Pre-CMP - Normal left ventricular wall thickness (≤ 12 mm) and normal LVEF (≥55%) on echocardiography within 3 months or increased wall thickness with normal cardiac biomarker levels: not...
- Additional for Control Multiple Myeloma people: diagnosis of multiple myeloma without concomitant amyloidosis by standard criteria
- Additional for Control Heart Failure people: diagnosis of heart failure without amyloidosis by standard criteria
- Additional for the active AL-CMP: Abnormal TnT 5th generation levels (\>9 ng/L: Female, \>14 ng/L: Male) or abnormal age appropriate N terminal pro-brain natriuretic peptide, NT-proBNP (abnormal values: \ 450 pg/ml...
- Hemodynamic instability
- Decompensated heart failure (unable to lie flat for 1 hour)
- Concomitant non-ischemic non-amyloid heart disease (valvular heart disease or dilated cardiomyopathy)
- Known obstructive epicardial coronary artery disease with stenosis \> 50% in any single territory
- Severe claustrophobia despite use of sedatives
- Presence of MRI contraindications such as metallic implants (pacemaker or ICD) at the time of study enrollment except for Control Heart Failure people. Control HF people with no devices, or, with strictly MR compatible...
- Significant renal dysfunction with estimated glomerular filtration rate \< 30 ml/min/m2 within 14 days of each cardiac MRI study. people who develop renal dysfunction over the course of the study, meeting criteria...
- people on dialysis will be excluded
- Pregnant state. For women in child bearing age, a urine pregnancy test will be performed prior to the PET and the cardiac MRI studies
- Documented allergy to F-18 florbetapir, C-11 acetate or gadolinium.
- Additional exclusion criteria for the active AL-CMP people: people unable to return to BWH for 6 and 12 month clinical evaluation
- Additional exclusion criteria for active AL-CMP-exercise people: Inability to exercise or return to BWH for C-11 acetate PET/CT at baseline and 6 month clinical evaluations.
- Additional exclusion criteria for active AL Pre-CMP- Inability to return to BWH 12 month clinical evaluation. Additional exclusion criteria for microbiota study: Documented hypertrophic cardiomyopathy, HIV or chronic...
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.