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

Cardiac Disease Clinical Trial

— CARTO-AMYLO  

Official title:

Frequency and Severity of Cardiac Injury in Transthyretin Cardiac Amyloidosis : an Electro Mapping Study.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04956965
• Other study ID #: 19_RIPH3-03
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2021
• Est. completion date: May 2022

Study information

• Verified date: July 2021
• Source: University Hospital Center of Martinique
• Contact: Jocelyne CRASPAG, MSc
• Phone: +596596592698
• Email: jocelyne.craspag[@]chu-martinique.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 ?

Description:

Transthyretin's amyloid heart disease (CATTR) is a rare disease whose frequency is high in the Caribbean's due to a high frequency of Val122Ile, an amyloidosis prone mutation in the Transthyretin gene. The Val122Ile variant might be present in 15 to 20 000 subjects in Martinique, placing them at high risk to develop the CATTR.

CATTR results from the accumulation of amyloid deposits between the intercellular spans, resulting in mechanical cardiac abnormalities, but also in latent excitation or conduction defects: atrial and ventricular hyperexcitability, bundle branch blocks, atrio-ventricular blocks. These abnormalities require systematic electrophysiological studies and if necessary, antiarrythmic medications or pacemaker placement.

Electro-mapping of the cardiac chambers offers high-resolution three-dimensional maps of cardiac electrical activity which has been used recently to detect focal myocardial infarction.

This anatomo-functional imaging, used only once in cardiac amyloidosis, showed a correlation between areas of low voltage of the left atrial myocardium and areas of late gadolinium enhancement, a marker of amyloidosis deposit, found in cardiac MRI.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: May 2022
• Est. primary completion date: August 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Controls:

• Aged 18 and more

• Have had an echocardiogram within 6 months prior to inclusion

• Have had a cardiac Holter in the 6 months prior to inclusion.

• Informed Consent given

Cases :

• Aged 18 and over

• Presence of cardiac amyloidosis with Transthyretin

• Have had an echocardiogram within 6 months prior to inclusion

• Have had a cardiac Holter monitoring in the 6 months prior to inclusion.

• Informed Consent given

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Amyloidosis
• Cardiac Amyloidosis
• Cardiac Disease
• Heart Diseases

Intervention

Radiation:
• Cardiac electro-mapping
Perform an high-resolution three-dimensional maps of cardiac electrical activity using EnSite Precision system.

Locations

Country	Name	City	State
Martinique	Centre Hospitalier Universitaire de Fort-de-France	Fort-de-France

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Center of Martinique	GIRCI SOHO

Country where clinical trial is conducted

Martinique, 

References & Publications (4)

Khairy LT, Barin R, Demonière 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. — View Citation

Oliveira Da Silva L, Fabre J, Monfort A, Villeret J, Citony I, Cohen-Tenoudji P, Lebbadi M, Martin D, Molinié 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. — View Citation

Parent F, Bachir D, Inamo J, Lionnet F, Driss F, Loko G, Habibi A, Bennani S, Savale L, Adnot S, Maitre B, Yaïci A, Hajji L, O'Callaghan DS, Clerson P, Girot R, Galacteros F, Simonneau G. A hemodynamic study of pulmonary hypertension in sickle cell diseas — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Characteristics of zones with electrical inactivity	Number of areas of electrical inactivity (<0.1 mV)	1 month
Secondary	Zones with electrical inactivity	Area of surface of electrical inactivity (<0.1 mV)	1 month
Secondary	Characteristics of zones with abnormal electrical activity	Number of areas of continuous low voltage activity	1 month
Secondary	Zones with abnormal electrical activity	Surface of areas of continuous low voltage activity	1 month
Secondary	Compare electrical activity anomaly to total longitudinal strain on cardiac ultrasound	Number of areas of electrical inactivity vs. total longitudinal strain on cardiac ultrasound.	1 month
Secondary	Electrical activity anomaly and total longitudinal strain on cardiac ultrasound	Number of areas of continuous low voltage activity vs. Total longitudinal strain on cardiac ultrasound.	1 month
Secondary	Compare electrical activity anomaly (surface) to total longitudinal strain on cardiac ultrasound	Surface of areas of electrical inactivity vs. Total longitudinal strain on cardiac ultrasound.	1 month
Secondary	Electrical activity anomaly (continuous low voltage activity) and total longitudinal strain on cardiac ultrasound	Surface of areas of continuous low voltage activity vs. Total longitudinal strain on cardiac ultrasound.	1 month
Secondary	Compare electrical activity anomaly to Brain Natriuretic Peptide (BNP) value	Number of areas of electrical inactivity vs. BNP value.	1 month
Secondary	Electrical activity and Brain Natriuretic Peptide (BNP) value	Number of areas of continuous low voltage activity vs. BNP value.	1 month
Secondary	Compare electrical activity anomaly (surface) to Brain Natriuretic Peptide (BNP) value	Surface of areas of electrical inactivity vs. BNP value.	1 month
Secondary	Electrical activity anomaly (continuous low voltage activity) and Brain Natriuretic Peptide (BNP) value	Surface of areas of continuous low voltage activity vs. BNP value.	1 month
Secondary	Compare electrical activity anomaly to the presence of severe ventricular arrhythmia	Number of areas of electrical inactivity vs. the presence of severe ventricular arrhythmia.	1 month
Secondary	Electrical activity anomaly and presence of severe ventricular arrhythmia	Number of areas of continuous low voltage activity vs. the presence of severe ventricular arrhythmia.	1 month
Secondary	Compare electrical activity anomaly (surface) to the presence of severe ventricular arrhythmia	Surface of areas of electrical inactivity vs. the presence of severe ventricular arrhythmia.	1 month
Secondary	Electrical activity anomaly (continuous low voltage activity) and presence of severe ventricular arrhythmia	Surface of areas of continuous low voltage activity vs. the presence of severe ventricular arrhythmia.	1 month
Secondary	Compare electrical activity anomaly and to the presence of an atrial arrythmia	Number of areas of electrical inactivity vs. the presence of an atrial fibrillation load.	1 month
Secondary	Electrical activity anomaly and presence of an atrial arrythmia	Number of areas of continuous low voltage activity vs. the presence of an atrial fibrillation load.	1 month
Secondary	Compare electrical activity anomaly (surface) to the presence of an atrial arrythmia	Surface of areas of electrical inactivity vs. the presence of an atrial fibrillation load.	1 month
Secondary	Electrical activity anomaly (continuous low voltage activity) and presence of an atrial arrythmia	Surface of areas of continuous low voltage activity vs. the presence of an atrial fibrillation load.	1 month