Assessment of Cardiac Autonomic Function in Adulthood After Chemotherapy or Radiotherapy in Childhood
NCT ID: NCT01574196
Last Updated: 2015-03-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
83 participants
OBSERVATIONAL
2012-09-30
2014-12-31
Brief Summary
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The rationale for this study is based on the observation that although the survival rate of childhood cancers has now reached 75%, complications of chemotherapy and radiotherapy are high and greatly increase the risk of mortality in later years (estimated to be 14% in the literature).
The morbidity risk of chemotherapy and radiotherapy can be quantified by assessing the activity of the intrinsic cardiac autonomic regulation, which represents a powerful predictor of cardiovascular morbidity to the individual.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Young adult survivors of childhood cancer
Young adult survivors of childhood cancer diagnosed between 1987 and 1992 in the Rhône-Alpes and Auvergne regions of France.
Autonomic nervous system activity records
The description of autonomic equilibrium is based on the use of non-invasive tools such as Holter-ECG monitor (24 hours) which is suitable for longitudinal follow up of cohorts of patients. This tool allows the analysis of instantaneous or delayed variability of the heart rate, in the Hertzian frequency domain after extraction and mathematical transformation of a temporal sequence of R-R spaces from the ECG signal.
Interventions
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Autonomic nervous system activity records
The description of autonomic equilibrium is based on the use of non-invasive tools such as Holter-ECG monitor (24 hours) which is suitable for longitudinal follow up of cohorts of patients. This tool allows the analysis of instantaneous or delayed variability of the heart rate, in the Hertzian frequency domain after extraction and mathematical transformation of a temporal sequence of R-R spaces from the ECG signal.
Eligibility Criteria
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Inclusion Criteria
* Having signed the informed consent form
Exclusion Criteria
* Known allergy to electrodes
18 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire de Saint Etienne
OTHER
Responsible Party
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Principal Investigators
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Claire BERGER, MD
Role: PRINCIPAL_INVESTIGATOR
CHU de Saint-Etienne
Hugues PATURAL, MD PhD
Role: STUDY_DIRECTOR
CHU de Saint-Etienne
Locations
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CHU de Clermont-Ferrand
Clermont-Ferrand, , France
CHU de Grenoble
Grenoble, , France
IHOP
Lyon, , France
CHU de Saint-Etienne
Saint-Etienne, , France
Countries
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Other Identifiers
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2011-A01357-34
Identifier Type: OTHER
Identifier Source: secondary_id
1108162
Identifier Type: -
Identifier Source: org_study_id
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