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Advanced Imaging Techniques for Cardiomyopathy (MICA Trial)
N/A
Recruiting
Led By Ronglih Liao, PhD
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of heart failure without amyloidosis by standard criteria
Ability to perform supine bicycle exercise. Enrollment to this arm will stop after 36 subjects complete baseline and 6 months studies.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6 and 12 months
Awards & highlights
MICA Trial Summary
This trial will use advanced imaging to visualize deposits of a heart disease, to develop treatments and save lives. #medicalresearch
Who is the study for?
Adults diagnosed with light chain amyloidosis or heart failure without amyloidosis, able to exercise and consent. Excludes those with severe coronary artery disease, claustrophobia that sedatives can't help, pregnancy, significant kidney dysfunction, certain metallic implants (except MR compatible devices for control subjects), on dialysis, unable to attend follow-up visits or lie flat for an hour.Check my eligibility
What is being tested?
The trial is testing advanced imaging methods like F-18 florbetapir/C-11 acetate PET scans and MRI to visualize cardiac amyloid deposits in patients with cardiac amyloidosis. The goal is to understand the mechanisms of cardiac dysfunction better.See study design
What are the potential side effects?
Potential side effects may include reactions related to the imaging agents used (F-18 florbetapir/C-11 acetate) such as allergic reactions. Gadolinium contrast used in MRI might cause issues if there's severe kidney dysfunction.
MICA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with heart failure, not caused by amyloidosis.
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I can do exercises on a bike while lying on my back.
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I have been diagnosed with light chain amyloidosis through specific tests.
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I have been diagnosed with multiple myeloma and do not have amyloidosis.
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I am older than 18 years.
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My blood cancer has been responding well to treatment for over a year.
MICA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 6 and 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6 and 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in F-18 florbetapir myocardial retention index from baseline to 6 months and 12 months
Change in Magnetic resonance imaging markers from baseline to 6 months and 12 months
Change in Myocardial oxidative metabolism markers from baseline to 6 months
+1 moreSecondary outcome measures
Change in Myocardial energy efficiency from baseline to 6 months
Light Chain Toxicity
Understand the role of gut microbiota and heavy metals in the pathogenesis of AL Amyloidosis
MICA Trial Design
5Treatment groups
Experimental Treatment
Active Control
Group I: Heart FailureExperimental Treatment2 Interventions
10 individuals with diagnosis of heart failure without amyloidosis by standard criteria will undergo a research F-18 florbetapir PET, C-11 acetate PET, and MRI of the heart, as well as a heavy metal analysis of the blood at baseline..
Group II: Active AL cardiac amyloidosisExperimental Treatment3 Interventions
75 individuals with light chain systemic amyloidosis with active plasma cell dyscrasia and cardiac involvement will undergo a research F-18 florbetapir PET, C-11 acetate PET, and MRI of blood of the heart, as well as the heavy metal analysis of the blood at baseline, 6 months and 12 months after initiation of chemotherapy. 25 of these individuals will also undergo a N-13 ammonia PET scan of the heart following supine bicycle stress at baseline and at 6 months after initiation of chemotherapy.
Group III: Active AL Pre-CMPExperimental Treatment2 Interventions
36 individuals with light chain systemic amyloidosis with active plasma cell dyscrasia and without cardiac involvement will undergo a research F-18 florbetapir PET, C-11 acetate PET, and MRI of the heart, as well as a heavy metal analysis of the blood at baseline. At 6 months they will undergo a research MRI of the heart and at 12 months they will have a clinical follow up. Subjects with contraindications to Cardiac MRI or gadolinium contrast may still be eligible for study participation.
Group IV: Multiple Myeloma ControlsActive Control1 Intervention
25 individuals with diagnosis of multiple myeloma without concomitant amyloidosis by standard criteria will undergo urine and blood testing only.
Group V: Remission AL cardiac amyloidosisActive Control2 Interventions
25 individuals with light chain systemic amyloidosis with cardiac involvement and plasma cell dyscrasia in hematological remission (complete hematological remission or very good partial response-differential free light chain (dFLC)<40 mg/dL for > 1 year prior to enrollment) will undergo a research F-18 florbetapir PET, C-11 acetate PET, and MRI scan of the heart as well as a heavy metal analysis of the blood at baseline.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MRI
2009
Completed Phase 2
~1370
Find a Location
Who is running the clinical trial?
Brigham and Women's HospitalLead Sponsor
1,624 Previous Clinical Trials
11,468,253 Total Patients Enrolled
9 Trials studying Amyloidosis
620 Patients Enrolled for Amyloidosis
National Institutes of Health (NIH)NIH
2,720 Previous Clinical Trials
7,494,275 Total Patients Enrolled
3 Trials studying Amyloidosis
92 Patients Enrolled for Amyloidosis
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,848 Previous Clinical Trials
47,818,091 Total Patients Enrolled
4 Trials studying Amyloidosis
1,492 Patients Enrolled for Amyloidosis
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a significant blockage in a heart artery.I cannot lie flat for an hour due to heart failure.I have not had recent infections, bowel issues, or treatments that could affect my eligibility.I have been diagnosed with heart failure, not caused by amyloidosis.My blood pressure and heart rate are stable.I cannot exercise or return for PET/CT scans at the required times.I can do exercises on a bike while lying on my back.I have heart disease that is not caused by blocked arteries or amyloid.I have been diagnosed with light chain amyloidosis through specific tests.I experience severe claustrophobia even with sedatives.I am allergic to F-18 florbetapir, C-11 acetate, or gadolinium.I am not on dialysis.My amyloidosis is localized and not affecting my whole body.My heart's main pumping chamber is of normal size and function.I have been diagnosed with multiple myeloma and do not have amyloidosis.I am older than 18 years.My kidney function is significantly impaired with an eGFR less than 30.Your blood tests show high levels of TnT or NT-proBNP, which could indicate heart problems.My blood cancer has been responding well to treatment for over a year.
Research Study Groups:
This trial has the following groups:- Group 1: Active AL Pre-CMP
- Group 2: Multiple Myeloma Controls
- Group 3: Heart Failure
- Group 4: Active AL cardiac amyloidosis
- Group 5: Remission AL cardiac amyloidosis
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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