Cardiac AmyloidosisCARTO-AMYLONCT04956965
High Resolution Three-dimensional Maps of the Right Chambers in Patient Diagnosed With Cardiac Amyloidosis
A study testing Cardiac electro-mapping in people with Cardiac Amyloidosis and Cardiac Disease, run by University Hospital Center of Martinique at 1 site in Martinique.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Amyloidosis, Cardiac Disease
- What is being tested?
- Cardiac electro-mapping
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteMartinique
- Study dates
- Aug 2021to May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 :
Show all 11Show fewer
- 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
Who cannot join
- 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.
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Martinique1 site
Centre Hospitalier Universitaire de Fort-de-France
Fort-de-France, 97261
Fabrice DEMONIERE, MD, +596596306490, fabrice.demoniere@chu-martinique.fr
Jocelyne CRASPAG, MSc, +596596592698, jocelyne.craspag@chu-martinique.fr
About this study
Official title: Frequency and Severity of Cardiac Injury in Transthyretin Cardiac Amyloidosis : an Electro Mapping Study.
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.
Read more
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 ?
Read the 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.
- Conditions
- Cardiac Amyloidosis, Cardiac Disease
- Being tested
- Cardiac electro-mapping
- Keywords
- Cardiac amyloidosis, Transthyretin, Val122Ile, Cardiac electro-mapping, EnSite Precision
- Medical subject headings
- Amyloid Neuropathies, Familial, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac electro-mappingRadiation
Perform an high-resolution three-dimensional maps of cardiac electrical activity using EnSite Precision system.
| Study group | Role | What they receive |
|---|---|---|
| Patient free cardiac amyloidosis | Active comparator | Patient with heart disease (related with rhythm disorders or conduction disorders) but free cardiac amyloidosis. Receives: 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). Receives: Radiation: Cardiac electro-mapping |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 month
Secondary outcomes (20)
Characteristics of zones with electrical inactivity
Number of areas of electrical inactivity (<0.1 mV)
Measured: 1 month
Zones with electrical inactivity
Area of surface of electrical inactivity (<0.1 mV)
Measured: 1 month
Characteristics of zones with abnormal electrical activity
Number of areas of continuous low voltage activity
Measured: 1 month
Zones with abnormal electrical activity
Surface of areas of continuous low voltage activity
Measured: 1 month
Compare electrical activity anomaly to total longitudinal strain on cardiac ultrasound
Number of areas of electrical inactivity vs. total longitudinal strain on cardiac ultrasound.
Measured: 1 month
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.
Measured: 1 month
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.
Measured: 1 month
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.
Measured: 1 month
Compare electrical activity anomaly to Brain Natriuretic Peptide (BNP) value
Number of areas of electrical inactivity vs. BNP value.
Measured: 1 month
Electrical activity and Brain Natriuretic Peptide (BNP) value
Number of areas of continuous low voltage activity vs. BNP value.
Measured: 1 month
Compare electrical activity anomaly (surface) to Brain Natriuretic Peptide (BNP) value
Surface of areas of electrical inactivity vs. BNP value.
Measured: 1 month
Electrical activity anomaly (continuous low voltage activity) and Brain Natriuretic Peptide (BNP) value
Surface of areas of continuous low voltage activity vs. BNP value.
Measured: 1 month
Compare electrical activity anomaly to the presence of severe ventricular arrhythmia
Number of areas of electrical inactivity vs. the presence of severe ventricular arrhythmia.
Measured: 1 month
Electrical activity anomaly and presence of severe ventricular arrhythmia
Number of areas of continuous low voltage activity vs. the presence of severe ventricular arrhythmia.
Measured: 1 month
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.
Measured: 1 month
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.
Measured: 1 month
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.
Measured: 1 month
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.
Measured: 1 month
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.
Measured: 1 month
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2021
- Study startAug 2021 (estimated)
- Primary completionAug 2021 (estimated)
- Study completionMay 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cardiac AmyloidosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Patient who needs electro-mapping in routine care.
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Center of Martinique
- Sponsor type
- University, hospital or other
- Collaborators
- GIRCI SOHO
- Responsible party
- Sponsor
- Investigators
- Jocelyn INAMO, MD, PhD, Study director, CHU de MartiniqueFabrice DEMONIERE, MD, Principal investigator, CHU de Martinique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04956965
- Sponsor's protocol ID
- 19_RIPH3-03
- Acronym
- CARTO-AMYLO
- Status last verified
- Jul 2021
- First submitted
- 21 Jun 2021
- Last updated
- 9 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28987521Wilber 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.
PubMed 20103757Parent 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.
PubMed 21732836Oliveira 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.
PubMed 25803389
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency and Severity of Cardiac Injury in Transthyretin Cardiac Amyloidosis : an Electro Mapping Study.
- ClinicalTrials.gov ID
- NCT04956965
- Acronym / sponsor ID
- CARTO-AMYLO / 19_RIPH3-03
- Conditions
- Cardiac Amyloidosis, Cardiac Disease
- Keywords
- Cardiac amyloidosis, Transthyretin, Val122Ile, Cardiac electro-mapping, EnSite Precision
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University Hospital Center of MartiniqueUniversity, hospital or other
- Collaborators
- GIRCI SOHO
- Study start
- Aug 2021 (estimated)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 9 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patient who needs electro-mapping in routine care.
| Arm | Type | Receives |
|---|---|---|
| Patient free cardiac amyloidosis | Active comparator | Radiation: Cardiac electro-mappingPatient with heart disease (related with rhythm disorders or conduction disorders) but free cardiac amyloidosis. |
| Patient with Transthyretin cardiac amyloidosis | Experimental | Radiation: Cardiac electro-mappingPatient with transthyretin cardiac amyloidosis plus heart disease (related with rhythm disorders or conduction disorders). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
- Aged 18 and over
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac electro-mappingPerform an high-resolution three-dimensional maps of cardiac electrical activity using EnSite Precision system. | Radiation | Patient free cardiac amyloidosis, Patient with Transthyretin cardiac amyloidosis |
Primary outcome
Percentage of zones with abnormal electrical activity
Time frame: 1 month
Percentage of subject with at least one area of electrical inactivity (<0.1 mV) or at least one area of continuous low-voltage activity
20 secondary outcomes
Characteristics of zones with electrical inactivity
Time frame: 1 month
Zones with electrical inactivity
Time frame: 1 month
Characteristics of zones with abnormal electrical activity
Time frame: 1 month
Zones with abnormal electrical activity
Time frame: 1 month
Compare electrical activity anomaly to total longitudinal strain on cardiac ultrasound
Time frame: 1 month
Electrical activity anomaly and total longitudinal strain on cardiac ultrasound
Time frame: 1 month
Compare electrical activity anomaly (surface) to total longitudinal strain on cardiac ultrasound
Time frame: 1 month
Electrical activity anomaly (continuous low voltage activity) and total longitudinal strain on cardiac ultrasound
Time frame: 1 month
Compare electrical activity anomaly to Brain Natriuretic Peptide (BNP) value
Time frame: 1 month
Electrical activity and Brain Natriuretic Peptide (BNP) value
Time frame: 1 month
Compare electrical activity anomaly (surface) to Brain Natriuretic Peptide (BNP) value
Time frame: 1 month
Electrical activity anomaly (continuous low voltage activity) and Brain Natriuretic Peptide (BNP) value
Time frame: 1 month
Compare electrical activity anomaly to the presence of severe ventricular arrhythmia
Time frame: 1 month
Electrical activity anomaly and presence of severe ventricular arrhythmia
Time frame: 1 month
Compare electrical activity anomaly (surface) to the presence of severe ventricular arrhythmia
Time frame: 1 month
Electrical activity anomaly (continuous low voltage activity) and presence of severe ventricular arrhythmia
Time frame: 1 month
Compare electrical activity anomaly and to the presence of an atrial arrythmia
Time frame: 1 month
Electrical activity anomaly and presence of an atrial arrythmia
Time frame: 1 month
Compare electrical activity anomaly (surface) to the presence of an atrial arrythmia
Time frame: 1 month
Electrical activity anomaly (continuous low voltage activity) and presence of an atrial arrythmia
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2021.
- Results publication: PubMed 28987521Khairy 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 publication: PubMed 20103757Wilber 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 publication: PubMed 21732836Parent 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 publication: PubMed 25803389Oliveira 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jocelyn INAMO, MD, PhD study director
CHU de Martinique
Fabrice DEMONIERE, MD principal investigator
CHU de Martinique
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac electro-mapping in people with Cardiac Amyloidosis and Cardiac Disease, run by University Hospital Center of Martinique at 1 site in Martinique.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Martinique. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jocelyne CRASPAG, MSc (+596596592698, jocelyne.craspag@chu-martinique.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of zones with abnormal electrical activity (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04956965, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2021.