Artificial Intelligence to Assist the Echocardiographic Identification of Transthyretin Cardiac Amyloidosis

NCT06328075 | Recruiting

• 2 other identifiers: AI-ATTR-ECHO20211029191554
• Study Type: observational
• Target: 15,000
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to develop an algorithm using artificial intelligence (AI) to assist identification of potential ATTR-CM cases using routine transthoracic echocardiography. The main questions it aims to answer are:

• is the algorithm able to diagnose ATTR-CM
• is the algorithm able to diagnose different types of ATTR-CM (ATTRv, ATTRwt) This is a non interventional study. Participant' echocardiographies will be, after deidentification, used to train, valid and test the algorithm.

Conditions

Amyloid Cardiomyopathy; Transthyretin Amyloid Cardiomyopathy; Transthyretin Cardiac Amyloidosis

Keywords

echocardiography; artificial intelligence; Transthyretin Amyloid Cardiomyopathy

Outcome Measures

Primary Outcomes (2)

• Building and validating the diagnostic performance metrics curves of the AI algorithm to diagnose ATTR-CM :

  To develop and validate a tool using artificial intelligence an algorithm that will improve the automatic detection on routinely acquired echocardiography images of aspects suggestive of transthyretin amyloidosis. A confusion matrix will be built and the following diagnostic performance metrics be computed: * receiver operating characteristic curve (ROC) and area under curve (AUC) of the ROC : AUROC * Precision recall curve (PR) and area under curve (AUC) of the PR curve : AUC-PR

  year 1

• Building and validating the diagnostic performance metrics of the AI algorithm to diagnose ATTR-CM :

  To develop and validate a tool using artificial intelligence an algorithm that will improve the automatic detection on routinely acquired echocardiography images of aspects suggestive of transthyretin amyloidosis ATTR. A confusion matrix will be built and the following diagnostic performance metrics be computed: Accuracy, Sensitivity or Recall, Specificity, False positive rate, False Negative Rate, Precision (all are expressed as ratio)

  year 1

Secondary Outcomes (8)

• Building and validating the diagnostic performance metrics of the AI algorithm to diagnose ATTRwt-CM :

  year 1

• Building and validating the diagnostic performance metrics of the AI algorithm to diagnose ATTRv-V122I-CM :

  year 1

• Building and validating the diagnostic performance metrics of the AI algorithm to diagnose ATTRv-CM :

  year 1

• Building and validating the diagnostic performance metrics of the AI algorithm to differentiate ATTR-CM from LV hypertrophy (LVH) :

  year 1

• Building and validating the diagnostic performance metrics curves of the AI algorithm to diagnose ATTRwt-CM :

  year 1

Study Arms (2)

Transthyretin cardiac amyloidosis (ATTR-CM)

Patients with an ATTR-CM and undergoing a transthoracic echocardiography

Other: non interventional study

Controls

Patients without cardiac amyloidosis undergoing transthoracic echocardiography as part of cardiological follow-up

Other: non interventional study

Interventions

non interventional study OTHER

non interventional study

Controls; Transthyretin cardiac amyloidosis (ATTR-CM)

Eligibility Criteria

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

Study Population

The ATTR-CM cohort will be recruited in referral tertiary centers for cardiac amyloidosis The Control cohort will be recruited in the same centers from patients presenting an indication for transthoracic echocardiography as part of cardiological follow-up

You may qualify if:

• Cardiac transthyretin amyloidosis diagnosed on the classic criteria:
• Absence of monoclonal immunoglobulin AND
• Presence of a bisphosphonate scintigraphy with enhancement in the cardiac area OR
• Presence of a cardiac biopsy showing transthyretin (Congo red positive) cardiac amyloidosis (demonstrated either by immunostaining or by mass spectrometry) OR 3-Presence of a peripheral biopsy showing transthyretin amyloidosis (see above) associated with cardiac infiltration (parietal thickness \>12mm without other cause of cardiac hypertrophy)
• No opposition to research
• Another cause of cardiac amyloidosis: AL AA amyloidosis…
• Mixed heart disease with associated presence of non-amyloid heart disease (ischemic heart disease, dilated, etc.)
• Control patients:
• Indication for transthoracic echocardiography as part of cardiological follow-up
• Patient affiliated with social security
• Patient's agreement to participate in the research and signature of the consent form.
• Technical conditions of the examination and echogenicity allowing acquisition of good quality echocardiographic images, allowing post processing
• Presence of cardiac amyloidosis as defined above
• Presence of transthyretin amyloidosis even without demonstrated cardiac involvement
• Patient monitored for asymptomatic transthyretin mutation

Sponsors & Collaborators

• Algalarrondo Vincent: lead
• Bichat Hospital: collaborator
• Bioquantis: collaborator

Study Sites (1)

Bichat

Paris, 75018, France

RECRUITING

MeSH Terms

Conditions

Amyloid Neuropathies, Familial

Condition Hierarchy (Ancestors)

Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Nervous System Diseases; Amyloid Neuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Amyloidosis, Familial; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases; Amyloidosis; Proteostasis Deficiencies

Study Officials

• Gabriel Steg, MD, PhD

  Bichat Hospital

  STUDY CHAIR

Central Study Contacts

Vincent Algalarrondo, MD, PhD

CONTACT

+33140257785; vincent.algalarrondo@aphp.fr

Gregory Ducrocq, MD, PhD

CONTACT

+33140256600; gregory.ducrocq@aphp.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, Director of the referral center CRMR -CERAMIC CARDIO

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: March 25, 2024
• Study Start: January 1, 2022
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2026
• Last Updated: March 25, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)