High Resolution Three-dimensional Maps of the Right Chambers in Patient Diagnosed With Cardiac Amyloidosis

NCT04956965 | Unknown

• 1 other identifier: 19_RIPH3-03
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Amyloid heart disease is an accumulation of fibrillar proteins in the extracellular sector of the heart. Identified on echocardiography as Ventricular hypertrophy. The investigation of a Left Ventricular hypertrophy (LVH) is the most frequent discovery circumstance of amyloid heart disease. Pathophysiological mechanisms poorly understood, resulting in late diagnosis. Transthyretin amyloid heart disease (CATTR) is the most common form of cardiac amyloidosis in the West Indies due to an abnormally high frequency of the Val122Ile and Val107Ile mutations of the transthyretin gene in this population. Val122Ile and Val107Ile mutated-transthyretin are the substitution of valine for isoleucine at codon 122 of the TTR gene ( V122I) and at codon 107 of the TTR gene (V107I). Complications of CATTR are functional changes in heart cells or even death due to mechanical abnormalities (loss of contractility and increased wall stiffness cardiac arousal and conduction disturbances). These disorders result from an electrical abnormality of the heart the reason why the cardiologist performs preventive performance of electrophysiological explorations with EnSite Precision™. It's a registration system used to detect foci of necrosis within the myocardium. Amyloid deposits are areas devoid of electrical activity. Do they detectable by the EnSite Precision™ recording system ?

Conditions

Cardiac Amyloidosis; Cardiac Disease

Keywords

Cardiac amyloidosis; Transthyretin; Val122Ile; Cardiac electro-mapping; EnSite Precision

Outcome Measures

Primary Outcomes (1)

• Percentage of zones with abnormal electrical activity

  Percentage of subject with at least one area of electrical inactivity (\<0.1 mV) or at least one area of continuous low-voltage activity

  1 month

Secondary Outcomes (20)

• Characteristics of zones with electrical inactivity

  1 month

• Zones with electrical inactivity

  1 month

• Characteristics of zones with abnormal electrical activity

  1 month

• Zones with abnormal electrical activity

  1 month

• Compare electrical activity anomaly to total longitudinal strain on cardiac ultrasound

  1 month

Study Arms (2)

Patient free cardiac amyloidosis

ACTIVE COMPARATOR

Patient with heart disease (related with rhythm disorders or conduction disorders) but free cardiac amyloidosis.

Radiation: Cardiac electro-mapping

Patient with Transthyretin cardiac amyloidosis

EXPERIMENTAL

Patient with transthyretin cardiac amyloidosis plus heart disease (related with rhythm disorders or conduction disorders).

Radiation: Cardiac electro-mapping

Interventions

Cardiac electro-mapping RADIATION

Perform an high-resolution three-dimensional maps of cardiac electrical activity using EnSite Precision system.

Patient free cardiac amyloidosis; Patient with Transthyretin cardiac amyloidosis

Eligibility Criteria

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

You may qualify if:

• Controls:
• Aged 18 and more
• Informed Consent given
• Cases :
• Aged 18 and over
• Presence of cardiac amyloidosis with Transthyretin
• Informed Consent given

You may not qualify if:

• Controls
• Known case of amyloidosis in the immediate family
• Patient known to have amyloidosis
• Left ventricular wall thickness greater than or equal to 14 mm
• Hyperechogenicity of the left ventricular walls
• Cardiac disease which may affect electro-anatomic mapping: Right ventricular dysplasia, myocardial infarction, congenital heart disease.
• Contraindication such as pregnancy to radiological exams
• Presence of an anomaly of the vena cava
• Presence of intracavitary thrombus at cardiac echocardiography
• Patients with a pacemaker
• Cases
• Cardiac disease which may affect electro-anatomic mapping: Right ventricular dysplasia, myocardial infarction, congenital heart disease.
• Contraindication such as pregnancy to radiological exams
• Presence of an anomaly of the vena cava
• Presence of intracavitary thrombus at cardiac echocardiography

Sponsors & Collaborators

• University Hospital Center of Martinique: lead
• GIRCI SOHO: collaborator

Study Sites (1)

Centre Hospitalier Universitaire de Fort-de-France

Fort-de-France, 97261, Martinique

Location

Related Publications (4)

• Khairy LT, Barin R, Demoniere F, Villemaire C, Billo MJ, Tardif JC, Macle L, Khairy P. Heart Rate Response in Spectators of the Montreal Canadiens Hockey Team. Can J Cardiol. 2017 Dec;33(12):1633-1638. doi: 10.1016/j.cjca.2017.08.002. Epub 2017 Oct 5.

  PMID: 28987521 RESULT

• Wilber DJ, Pappone C, Neuzil P, De Paola A, Marchlinski F, Natale A, Macle L, Daoud EG, Calkins H, Hall B, Reddy V, Augello G, Reynolds MR, Vinekar C, Liu CY, Berry SM, Berry DA; ThermoCool AF Trial Investigators. Comparison of antiarrhythmic drug therapy and radiofrequency catheter ablation in patients with paroxysmal atrial fibrillation: a randomized controlled trial. JAMA. 2010 Jan 27;303(4):333-40. doi: 10.1001/jama.2009.2029.

  PMID: 20103757 RESULT

• Parent F, Bachir D, Inamo J, Lionnet F, Driss F, Loko G, Habibi A, Bennani S, Savale L, Adnot S, Maitre B, Yaici A, Hajji L, O'Callaghan DS, Clerson P, Girot R, Galacteros F, Simonneau G. A hemodynamic study of pulmonary hypertension in sickle cell disease. N Engl J Med. 2011 Jul 7;365(1):44-53. doi: 10.1056/NEJMoa1005565.

  PMID: 21732836 RESULT

• Oliveira Da Silva L, Fabre J, Monfort A, Villeret J, Citony I, Cohen-Tenoudji P, Lebbadi M, Martin D, Molinie V, Inamo J. 'Green Apple' Heart Failure. West Indian Med J. 2014 Jul 3;63(6):673-5. doi: 10.7727/wimj.2013.255. Epub 2014 Jun 25.

  PMID: 25803389 RESULT

MeSH Terms

Conditions

Amyloid Neuropathies, Familial; Heart Diseases

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; Cardiovascular Diseases

Study Officials

• Jocelyn INAMO, MD, PhD

  CHU de Martinique

  STUDY DIRECTOR

• Fabrice DEMONIERE, MD

  CHU de Martinique

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jocelyne CRASPAG, MSc

CONTACT

+596596592698; jocelyne.craspag@chu-martinique.fr

Fabrice DEMONIERE, MD

CONTACT

+596596306490; fabrice.demoniere@chu-martinique.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patient who needs electro-mapping in routine care.

Study Record Dates

• First Submitted: June 21, 2021
• First Posted: July 9, 2021
• Study Start: August 1, 2021
• Primary Completion: August 1, 2021
• Study Completion: May 1, 2022
• Last Updated: July 9, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

MA (1)