A Study of Different Heart Imaging Techniques to Detect Amyloidosis Involving the Heart
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 12-006763
Sponsor Protocol Number: 12-006763
About this study
The purpose of this study is to evaluate different heart imaging techniques to detect amyloidosis involving the heart. We are doing this research study to characterize the differences between types of amyloid and other diseases that mimic the appearance of amyloid involving the heart by using several imaging studies.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Patient is ≥ 40 years-old.
- If female, patient is post-menopausal or negative pregnancy (blood or urine) test through Mayo laboratory prior to nuclear imaging study.
AL-CM Arm:
- Patient has documented AL-CM defined as:
- Presence of amyloid in cardiac biopsy tissue (as determined by congo red stain or sulfated alcin blue stain), or
- Evidence of cardiac amyloid involvement by echocardiography and presence of amyloid in non-cardiac biopsy tissue
- High clinical suspicion of AL amyloid and subtyping by mass spectrometry ordered for confirmation
ATTR-CM Arm:
- Variant TTR amyloid cardiomyopathy as defined as:
- Known amyloid-associated genotype by direct sequencing of entire TTR gene and presence of amyloid in cardiac biopsy tissue (as determined by congo red stain, alcin blue stain, or mass spec analysis), or
- Variant TTR amyloid cardiomyopathy as defined as:
- Known amyloid-associated genotype by direct sequencing of entire TTR gene, evidence of cardiac involvement by echocardiography with left ventricle wall thickness > 12 mm and presence of amyloid in non-cardiac biopsy tissue (as determined by congo red stain, alcin blue stain, or mass spec analysis), or
- Wild-type TTR amyloid cardiomyopathy as defined as:
- Normal TTR genotype and presence of TTR amyloid deposits in cardiac biopsy tissue (as determined by congo red stain and mass spec analysis), or
- Wild-type TTR amyloid cardiomyopathy as defined as:
- Normal TTR genotype, evidence of cardiac involvement by echocardiography with left ventricle wall thickness > 12 mm and presence of TTR amyloid deposits in non-cardiac biopsy tissue (as determined by congo red stain and mass spec analysis).
Non-amyloid Control Arm:
-
No clinical or laboratory evidence of amyloid.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator John Askew, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available