Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00127582
Status:
UNKNOWN
Last Update Posted:
2005-08-25
First Post:
2005-08-04
Brief Title:
RAMYD Study - Evaluation of Arrhythmic Risk in Myotonic Dystrophy
Sponsor:
Catholic University of the Sacred Heart
Organization:
Catholic University of the Sacred Heart
Study Overview
Official Title:
Evaluation of Arrhythmic Risk in Myotonic Dystrophy Type I DM 1
Status:
UNKNOWN
Status Verified Date:
2005-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a prospective multicentric Italian study to evaluate the arrhythmic risk in myotonic dystrophy type 1
Detailed Description:
Myotonic dystrophy type 1 DM1 Steinert disease is a multisystem disorder that affects beside muscle several other organs including the heart
Cardiac involvement represents a major problem in the clinical management of patients so that cardiac complications represent one of the primary causes of premature death in DM1 In particular there is a high incidence of sudden death ranging from 2 to 30 of cases so far principally related to the development of conduction blocks However literature reports of sudden death in patients implanted with pacemakers as well as of spontaneous ventricular tachycardia would suggest a potential etiologic role also for ventricular arrhythmias The lack of clinical research studies conducted on a large number of patients does not make available definite data regarding the etiology and the epidemiology of arrhythmic events in DM1 For the same reasons other considerable topics such as prognostic stratification of the arrhythmic risk and clinical management of life-threatening arrhythmias in DM1 patients are still undefined
To clarify these issues the investigators propose a clinical research study performed on a large cohort of DM1 patients enrolled through a multicenter collaboration that also involves 5 cardiological-neurological Italian centres
Aims of this study are
To estimate the incidence of arrhythmias and to characterize the brady-tachyarrhythmic mechanisms underlying the occurrence of cardiac sudden death in DM1
To verify by statistical analysis the reliability of data obtained from both non invasive and invasive diagnostic procedures as indexes useful for estimating the arrhythmic risk in DM1
To identify more adequate therapeutic guidelines in order to prevent the occurrence of life-threatening arrhythmias
The protocol of study includes
1 Clinical-genetic evaluation
2 Non invasive and invasive diagnostic cardiac procedures
3 The use of devices for diagnostic and therapeutic follow-up
Cardiac involvement represents a major problem in the clinical management of patients so that cardiac complications represent one of the primary causes of premature death in DM1 In particular there is a high incidence of sudden death ranging from 2 to 30 of cases so far principally related to the development of conduction blocks However literature reports of sudden death in patients implanted with pacemakers as well as of spontaneous ventricular tachycardia would suggest a potential etiologic role also for ventricular arrhythmias The lack of clinical research studies conducted on a large number of patients does not make available definite data regarding the etiology and the epidemiology of arrhythmic events in DM1 For the same reasons other considerable topics such as prognostic stratification of the arrhythmic risk and clinical management of life-threatening arrhythmias in DM1 patients are still undefined
To clarify these issues the investigators propose a clinical research study performed on a large cohort of DM1 patients enrolled through a multicenter collaboration that also involves 5 cardiological-neurological Italian centres
Aims of this study are
To estimate the incidence of arrhythmias and to characterize the brady-tachyarrhythmic mechanisms underlying the occurrence of cardiac sudden death in DM1
To verify by statistical analysis the reliability of data obtained from both non invasive and invasive diagnostic procedures as indexes useful for estimating the arrhythmic risk in DM1
To identify more adequate therapeutic guidelines in order to prevent the occurrence of life-threatening arrhythmias
The protocol of study includes
1 Clinical-genetic evaluation
2 Non invasive and invasive diagnostic cardiac procedures
3 The use of devices for diagnostic and therapeutic follow-up
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None