Early Diagnosis of Age-Linked CArdiac TransThyRetin Amyloidosis by Selective Screening in Spinal Stenosis Surgery

NCT06101108 | Recruiting

• 1 other identifier: ALCATTRASS
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to keep track of the cardiological follow-up of patients who have undergone back surgery because of symptomatic narrowing of the spinal canal and in whom microscopic examination of the tissue removed during this surgery showed a high amount of local deposits of small proteins. This finding may be an early sign of a condition in which other organs (especially the heart) may also be affected by these proteins, called amyloidosis. Patients who participate in this study, will be followed up for life. During the first routine consultation with the cardiologist, the physician-investigator will collect information, such as demographics (age, weight, height, gender), medical history, medication, symptoms and the results of prescribed examinations. These examinations include microscopic examination of tissue removed during the surgery, blood tests, electrocardiography, echocardiography and a bone scan. These examinations are clinically necessary and appropriate, and patients should undergo them even without participating in the study.

Conditions

Transthyretin Amyloid Cardiomyopathy

Outcome Measures

Primary Outcomes (1)

• Rate of diagnosis of cardiac amyloidosis

  Diagnosis of transthyretin amyloid cardiomyopathy

  1 week

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All consecutive patients ≥60 years old that undergo lumbar spinal stenosis surgery at the neurosurgery or orthopaedic department with Westermark grade 3 or 4 ATTR amyloid burden on ligamentum flavum biopsy

You may qualify if:

• ≥ 60 years old
• Lumbar spinal canal stenosis, undergoing spinal surgery
• Westermark grade 3 or 4 ATTR amyloid burden on ligamentum flavum biopsy

You may not qualify if:

• Prior diagnosis of cardiac amyloidosis
• Unwilling to provide informed consent

Sponsors & Collaborators

• Philippe Debonnaire: lead

Study Sites (1)

AZ Sint-Jan Brugge AV

Bruges, Belgium

RECRUITING

Study Officials

• Philippe Debonnaire, MD, PhD

  AZ Sint-Jan Brugge AV

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emma Christiaen

CONTACT

0032 50 45 32 93; emma.christiaen@azsintjan.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Investigator

Study Record Dates

• First Submitted: October 20, 2023
• First Posted: October 26, 2023
• Study Start: June 24, 2024
• Primary Completion: June 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: August 7, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)