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

Primary Purpose

Cardiac Amyloidosis, Cardiac Disease

Status
Unknown status
Phase
Not Applicable
Locations
Martinique
Study Type
Interventional
Intervention
Cardiac electro-mapping
Sponsored by
University Hospital Center of Martinique
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cardiac Amyloidosis focused on measuring Cardiac amyloidosis, Transthyretin, Val122Ile, Cardiac electro-mapping, EnSite Precision

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Hospitalier Universitaire de Fort-de-France

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Patient free cardiac amyloidosis

Patient with Transthyretin cardiac amyloidosis

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Characteristics of zones with electrical inactivity
Number of areas of electrical inactivity (<0.1 mV)
Zones with electrical inactivity
Area of surface of electrical inactivity (<0.1 mV)
Characteristics of zones with abnormal electrical activity
Number of areas of continuous low voltage activity
Zones with abnormal electrical activity
Surface of areas of continuous low voltage activity
Compare electrical activity anomaly to total longitudinal strain on cardiac ultrasound
Number of areas of electrical inactivity vs. total longitudinal strain on cardiac ultrasound.
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.
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.
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.
Compare electrical activity anomaly to Brain Natriuretic Peptide (BNP) value
Number of areas of electrical inactivity vs. BNP value.
Electrical activity and Brain Natriuretic Peptide (BNP) value
Number of areas of continuous low voltage activity vs. BNP value.
Compare electrical activity anomaly (surface) to Brain Natriuretic Peptide (BNP) value
Surface of areas of electrical inactivity vs. BNP value.
Electrical activity anomaly (continuous low voltage activity) and Brain Natriuretic Peptide (BNP) value
Surface of areas of continuous low voltage activity vs. BNP value.
Compare electrical activity anomaly to the presence of severe ventricular arrhythmia
Number of areas of electrical inactivity vs. the presence of severe ventricular arrhythmia.
Electrical activity anomaly and presence of severe ventricular arrhythmia
Number of areas of continuous low voltage activity vs. the presence of severe ventricular arrhythmia.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
June 21, 2021
Last Updated
July 7, 2021
Sponsor
University Hospital Center of Martinique
Collaborators
GIRCI SOHO
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1. Study Identification

Unique Protocol Identification Number
NCT04956965
Brief Title
High Resolution Three-dimensional Maps of the Right Chambers in Patient Diagnosed With Cardiac Amyloidosis
Acronym
CARTO-AMYLO
Official Title
Frequency and Severity of Cardiac Injury in Transthyretin Cardiac Amyloidosis : an Electro Mapping Study.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 2021 (Anticipated)
Primary Completion Date
August 2021 (Anticipated)
Study Completion Date
May 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Center of Martinique
Collaborators
GIRCI SOHO

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 ?
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Amyloidosis, Cardiac Disease
Keywords
Cardiac amyloidosis, Transthyretin, Val122Ile, Cardiac electro-mapping, EnSite Precision

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patient who needs electro-mapping in routine care.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patient free cardiac amyloidosis
Arm Type
Active Comparator
Arm Description
Patient with heart disease (related with rhythm disorders or conduction disorders) but free cardiac amyloidosis.
Arm Title
Patient with Transthyretin cardiac amyloidosis
Arm Type
Experimental
Arm Description
Patient with transthyretin cardiac amyloidosis plus heart disease (related with rhythm disorders or conduction disorders).
Intervention Type
Radiation
Intervention Name(s)
Cardiac electro-mapping
Intervention Description
Perform an high-resolution three-dimensional maps of cardiac electrical activity using EnSite Precision system.
Primary Outcome Measure Information:
Title
Percentage of zones with abnormal electrical activity
Description
Percentage of subject with at least one area of electrical inactivity (<0.1 mV) or at least one area of continuous low-voltage activity
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Characteristics of zones with electrical inactivity
Description
Number of areas of electrical inactivity (<0.1 mV)
Time Frame
1 month
Title
Zones with electrical inactivity
Description
Area of surface of electrical inactivity (<0.1 mV)
Time Frame
1 month
Title
Characteristics of zones with abnormal electrical activity
Description
Number of areas of continuous low voltage activity
Time Frame
1 month
Title
Zones with abnormal electrical activity
Description
Surface of areas of continuous low voltage activity
Time Frame
1 month
Title
Compare electrical activity anomaly to total longitudinal strain on cardiac ultrasound
Description
Number of areas of electrical inactivity vs. total longitudinal strain on cardiac ultrasound.
Time Frame
1 month
Title
Electrical activity anomaly and total longitudinal strain on cardiac ultrasound
Description
Number of areas of continuous low voltage activity vs. Total longitudinal strain on cardiac ultrasound.
Time Frame
1 month
Title
Compare electrical activity anomaly (surface) to total longitudinal strain on cardiac ultrasound
Description
Surface of areas of electrical inactivity vs. Total longitudinal strain on cardiac ultrasound.
Time Frame
1 month
Title
Electrical activity anomaly (continuous low voltage activity) and total longitudinal strain on cardiac ultrasound
Description
Surface of areas of continuous low voltage activity vs. Total longitudinal strain on cardiac ultrasound.
Time Frame
1 month
Title
Compare electrical activity anomaly to Brain Natriuretic Peptide (BNP) value
Description
Number of areas of electrical inactivity vs. BNP value.
Time Frame
1 month
Title
Electrical activity and Brain Natriuretic Peptide (BNP) value
Description
Number of areas of continuous low voltage activity vs. BNP value.
Time Frame
1 month
Title
Compare electrical activity anomaly (surface) to Brain Natriuretic Peptide (BNP) value
Description
Surface of areas of electrical inactivity vs. BNP value.
Time Frame
1 month
Title
Electrical activity anomaly (continuous low voltage activity) and Brain Natriuretic Peptide (BNP) value
Description
Surface of areas of continuous low voltage activity vs. BNP value.
Time Frame
1 month
Title
Compare electrical activity anomaly to the presence of severe ventricular arrhythmia
Description
Number of areas of electrical inactivity vs. the presence of severe ventricular arrhythmia.
Time Frame
1 month
Title
Electrical activity anomaly and presence of severe ventricular arrhythmia
Description
Number of areas of continuous low voltage activity vs. the presence of severe ventricular arrhythmia.
Time Frame
1 month
Title
Compare electrical activity anomaly (surface) to the presence of severe ventricular arrhythmia
Description
Surface of areas of electrical inactivity vs. the presence of severe ventricular arrhythmia.
Time Frame
1 month
Title
Electrical activity anomaly (continuous low voltage activity) and presence of severe ventricular arrhythmia
Description
Surface of areas of continuous low voltage activity vs. the presence of severe ventricular arrhythmia.
Time Frame
1 month
Title
Compare electrical activity anomaly and to the presence of an atrial arrythmia
Description
Number of areas of electrical inactivity vs. the presence of an atrial fibrillation load.
Time Frame
1 month
Title
Electrical activity anomaly and presence of an atrial arrythmia
Description
Number of areas of continuous low voltage activity vs. the presence of an atrial fibrillation load.
Time Frame
1 month
Title
Compare electrical activity anomaly (surface) to the presence of an atrial arrythmia
Description
Surface of areas of electrical inactivity vs. the presence of an atrial fibrillation load.
Time Frame
1 month
Title
Electrical activity anomaly (continuous low voltage activity) and presence of an atrial arrythmia
Description
Surface of areas of continuous low voltage activity vs. the presence of an atrial fibrillation load.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jocelyne CRASPAG, MSc
Phone
+596596592698
Email
jocelyne.craspag@chu-martinique.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Fabrice DEMONIERE, MD
Phone
+596596306490
Email
fabrice.demoniere@chu-martinique.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jocelyn INAMO, MD, PhD
Organizational Affiliation
CHU de Martinique
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Fabrice DEMONIERE, MD
Organizational Affiliation
CHU de Martinique
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Universitaire de Fort-de-France
City
Fort-de-France
ZIP/Postal Code
97261
Country
Martinique
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabrice DEMONIERE, MD
Phone
+596596306490
Email
fabrice.demoniere@chu-martinique.fr
First Name & Middle Initial & Last Name & Degree
Jocelyne CRASPAG, MSc
Phone
+596596592698
Email
jocelyne.craspag@chu-martinique.fr
First Name & Middle Initial & Last Name & Degree
Jocelyn INAMO, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28987521
Citation
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.
Results Reference
result
PubMed Identifier
20103757
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 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.
Results Reference
result
PubMed Identifier
21732836
Citation
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.
Results Reference
result
PubMed Identifier
25803389
Citation
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.
Results Reference
result

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

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