Recruiting

Transthyretin AmyloidosisAnalysis of Lumbar Spine Stenosis Specimens for Identification of Transthyretin Cardiac Amyloidosis

Sponsor:

Columbia University

Code:

NCT06034405

Conditions

Lumbar Spinal Stenosis

Cardiac Amyloidosis

ATTR Amyloidosis Wild Type

ATTR Gene Mutation

ATTRV122I Amyloidosis

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Accepted

Interventions

Tc99-PYP or Tc99-HDMP Scan

Study Details

Brief summary:

Primary objective:

To identify older adults with transthyretin cardiac amyloidosis (ATTR-CA) early in the course of the illness, at a time when disease modifying therapies are most effective.

The specific aims of this epidemiologic investigation include:

1. To identify subjects with previous lumbar spinal stenosis (LSS) Surgery who have evidence of transthyretin (TTR) amyloid deposits in spinal specimens and could be at risk for ATTR cardiac amyloidosis.
2. To evaluate for ATTR-CA among those with localized TTR in the spinal tissue.

The study will also explore the following:

1. The prevalence of amyloid in lumbar spinal stenosis specimens by Congo Red staining.
2. The prevalence of TTR deposits among subjects with amyloid as determined by mass spectrometry.
3. Evaluation of a novel artificial intelligence technique for that can identify amyloid histologically with standard H\&E staining.
4. Difference in ATTR-CA prevalence between subjects with TTR and indeterminate amyloid deposits in subject's spine by myocardial uptake of technetium pyrophosphate scan (Tc99-PYP).

Conditions

Lumbar Spinal Stenosis

Cardiac Amyloidosis

ATTR Amyloidosis Wild Type

ATTR Gene Mutation

ATTRV122I Amyloidosis

Study ID

NCT06034405

Start date

Sep 19, 2023

Status verified date

Jun, 2026

Completion date

May, 2028

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Clinically indicated spinal decompressive surgery within 20 years prior to enrollment.
2. Age ≥50 years at the time of the surgery.
3. Able to understand and sign the informed consent document after the nature of the study has been fully explained.

Exclusion Criteria:

The presence of any of the following excludes eligibility for enrollment in this study:

1. Confirmed primary amyloidosis (AL) or secondary amyloidosis (AA).
2. Known TTR amyloidosis.
3. Other reason that would make the subject inappropriate for entry into this study.

Study Design

Enrollment

1663 participants

Anticipated

Interventions and Outcome Measures

Arms

ATTR Negative

Participants who have undergone previous lumbar spinal, and/or carpel tunnel surgery will provide medical record data and spinal specimen for analysis of presence of ATTR amyloid.

ATTR Positive

Participants who have undergone previous lumbar spinal, and/or carpel tunnel surgery will provide medical record data, spinal specimen, prospective data from cardiac workup with confirmed ATTR amyloid in spinal specimen then undergo cardiac workup for cardiac phenotyping/genotyping.

Interventions

Tc99-PYP or Tc99-HDMP Scan

Difference in ATTR-CA prevalence between subjects with TTR and indeterminate amyloid deposits in their spine by myocardial uptake of Tc99-PYP.

Primary outcome measure

Percent of subjects with previous LSS surgery who have evidence of TTR amyloid deposits in their spinal specimen and could be at risk for ATTR cardiac amyloidosis [ Time Frame: up to 3 years ]

Central Contacts and Locations

Central contacts

Mathew S Maurer, MD

212-932-4537 msm10@cumc.columbia.edu

Samantha L Guadalupe, MHA

212-932-4537 slg2172@cumc.columbia.edu

Locations

Cedars-Sinai Medical Center

Recruiting

Beverly Hills, California, United States, 90211

Contacts

Shruti Shantharam

310-248-8365 shruti.shantharam@csmns.org

Christine Sumbi

310-248-8327 christine.sumbi@csmns.org

Principal Investigator:

Jignesh Patel, MD

Tufts Medical Center

Recruiting

Boston, Massachusetts, United States, 02111

Contacts

Ayan Patel, MD

617-636-4184 ayan.patel@tuftsmedicine.org

James Kryzanski, MD

617-636-8585 james.kryzanski@tuftsmedicine.org

Principal Investigator:

Ayan Patel, MD

Boston Medical Center

Recruiting

Boston, Massachusetts, United States, 02359

Contacts

Frederick Ruberg, MD

617-638-8771 frederick.ruberg@bmc.org

Denise Fine

617-638-8716 denise.fine@bmc.org

Principal Investigator:

Frederick Ruberg, MD

Columbia University Irving Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

Jeffeny DeLosSantos, MHA

212-932-4537 jd3456@cumc.columbia.edu

Samantha L Guadalupe, MHA

212-932-4537 slg2172@cumc.columbia.edu

Principal Investigator:

Mathew S Maurer, MD

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Mazen Hanna, MD

216-444-3490 hannam@ccf.org

Lauren Ives, RN

216-316-3370 ivesl@ccf.org

Principal Investigator:

Mazen Hanna, MD

More Information

Sponsor

Columbia University

Last update posted

Jun 4, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Columbia University on 2026-06-04.