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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 below

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 and 12 months for reporting.

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 more

Secondary 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

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor

1,614 Previous Clinical Trials

11,470,664 Total Patients Enrolled

9 Trials studying Amyloidosis

620 Patients Enrolled for Amyloidosis

National Institutes of Health (NIH)NIH

2,698 Previous Clinical Trials

7,492,328 Total Patients Enrolled

3 Trials studying Amyloidosis

92 Patients Enrolled for Amyloidosis

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,836 Previous Clinical Trials

47,850,686 Total Patients Enrolled

4 Trials studying Amyloidosis

1,492 Patients Enrolled for Amyloidosis

Media Library

F-18 florbetapir/C-11 acetate PET Clinical Trial Eligibility Overview. Trial Name: NCT02641145 — N/A

Amyloidosis Research Study Groups: Active AL Pre-CMP, Multiple Myeloma Controls, Heart Failure, Active AL cardiac amyloidosis, Remission AL cardiac amyloidosis

Amyloidosis Clinical Trial 2023: F-18 florbetapir/C-11 acetate PET Highlights & Side Effects. Trial Name: NCT02641145 — N/A

F-18 florbetapir/C-11 acetate PET 2023 Treatment Timeline for Medical Study. Trial Name: NCT02641145 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the eligibility of this experiment extend to octogenarians?

"The eligibility requirements for this experimental trial specify that the minimum age is eighteen and the maximum age to participate is ninety-nine."

Answered by AI

How many participants have enrolled in this experiment?

"Affirmative. Clinicaltrials.gov hosts information verifying that this clinical trial is presently recruiting participants; the initial posting was on April 1st 2016 and it has recently been modified on October 23rd 2022. Only one location is currently accepting 171 patients for the study."

Answered by AI

Is participation in this experiment still available to those interested?

"According to clinicaltrials.gov, this experiment is still accepting patients into its cohort and was initially posted on April 1st 2016 with the most recent edit having been made on October 23rd 2022."

Answered by AI

What criteria must be met to qualify for participation in this experiment?

"This medical trial is actively seeking171 volunteers aged between 18 and 99 with cardiomyopathy. Furthermore, additional criteria must be met depending on the arm of the study: those in Group D need to have localized amyloid deposition and non-systemic AL disease; participants in the Active AL-CMP - exercise arm should demonstrate an aptitude for supine bicycle exercises; Control Multiple myeloma patients require a diagnosis of multiple myeloma without concomitant amyloidosis by standard criteria; lastly, Control Heart failure subjects must possess a diagnosis of heart failure without amyloidosis according to established standards."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Molecular Imaging of Primary Amyloid Cardiomyopathy

Sharmila Dorbala 2016. "Molecular Imaging of Primary Amyloid Cardiomyopathy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02641145.

All > Cardiomyopathy > Amyloidosis