CARTO-AMYLO
Frequency and Severity of Cardiac Injury in Transthyretin Cardiac Amyloidosis : an Electro Mapping Study.
Sponsor study identifier
interventional
24
1 country
1
Study Start
August 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
August 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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 ?
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 21, 2021
Actual (reported)July 9, 2021
Actual (reported)August 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
August 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
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
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).
Perform an high-resolution three-dimensional maps of cardiac electrical activity using EnSite Precision system.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Centre Hospitalier Universitaire de Fort-de-France
Fort-de-France, 97261, Martinique
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.
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.
Jocelyn INAMO, MD, PhD
CHU de Martinique
Fabrice DEMONIERE, MD
CHU de Martinique
First Submitted
June 21, 2021
First Posted
July 9, 2021
Study Start
August 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
Artificial Intelligence Enhanced ECG to Detect Cardiac Amyloidosis
Contact the study team to confirm eligibility.
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.
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.
August 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
July 9, 2021
Record last verified: 2021-07
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