Trial record 5 of 6 for:    "sudden infant death" | Open Studies

Validation of a Non Invasive Blood Marker of SIDS and Vagal Disorders

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by University Hospital, Strasbourg, France.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT01358461
First received: May 20, 2011
Last updated: June 14, 2012
Last verified: June 2012
  Purpose

Context

The investigators recently demonstrated a highly significant increase in muscarinic receptor density in the myocardium of infants deceased from sudden infant death syndrome (SIDS) compared to those of infants deceased from identified causes 1. Muscarinic receptor overexpression was found in all SIDS samples studied to date. It was associated with an average increase in acetylcholinesterase activity, appearing as a compensatory mechanism to oppose the cardiac muscarinic receptor overexpression. Similar vago-cardiac abnormalities were detected in a rabbit model of vagal hyperreactivity that the investigators first described some years ago2. In these hyperreactive animals, expression of muscarinic receptors was also enhanced in blood white cells. Noticeably, the pattern of changes in these cells paralleled the pattern of changes in the heart. Thus, muscarinic abnormalities in cardiac tissues could be inferred with high confidence from those measured in lymphocytes.This was the first report of a vago-cardiac abnormality in sudden infant death syndrome. The investigators findings also provided original and important perspectives for the identification and therapeutic management of infants at risk of sudden death. As such, the publication of the investigators work raised a major interest from the population and from the scientific and medical communities, in particular cardio-pediatricians. ObjectivesThe objective of the present clinical project is to validate, in human lymphocytes, muscarinic receptor expression level (assessed by quantitative RT-PCR) as a circulating biomarker of autonomic nervous system dysfunction and more specifically, of vagal hyperactivity and of risk of sudden death. The project will include 2 major items, conducted in parallel:1. evaluation of the muscarinic receptor expression in lymphocytes from adults with vagal syncopes (n=60 patients from an existing file versus 60 controls) (Cardiology unit + Clinical Investigation Centre (CIC) + Laboratory of Neurobiology and Cardiovascular Pharmacology); 2. evaluation of the muscarinic receptor expression in lymphocytes from children with vagal syncopes (n=60 versus 60 controls) (Pediatry unit + Clinical Investigation Centre + Laboratory of Neurobiology and Cardiovascular Pharmacology).PerspectivesThis project represents the first step of validation of a circulating marker of vagal hyperactivity and of risk of SIDS in human. Once this step is completed, the investigators will start with the prospective study " muscarinic receptor expression in lymphocytes and SIDS " (cord blood collected at birth and follow up of the new-borns) (Maternity ward + CIC + Laboratory of Neurobiology and Cardiovascular Pharmacology). Then therapeutic preventive management becomes a realistic objective. A therapeutic clinical study will then be started with atropinic drugs, in order to test their potential protective action against sudden death. The final objective of the investigators research is the prevention of SIDS through i) identification - as soon as birth - of new-borns at high risk and ii) appropriate prophylactic therapy. The investigators work also opens exciting perspectives in the field of the still poorly understood vagal disorders in children and adults such as vagal pauses.1 Livolsi et coll, Plos One 5, e9464, 2010 ; 2 Livolsi et coll, Circulation 106, 2301-2304, 2002


Condition Intervention
Vagal Syncope
Biological: Blood sampling
Other: ECG-Holter 24 h tape and sino-carotid stimulation test

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Circulating Biomarker(s) of Muscarinic Receptor Overexpression and Vagal Disorders.

Resource links provided by NLM:


Further study details as provided by University Hospital, Strasbourg, France:

Biospecimen Retention:   Samples Without DNA

Blood


Estimated Enrollment: 240
Study Start Date: May 2011
Groups/Cohorts Assigned Interventions
Patients with vagal syncopes
Patients with vagal syncopes (n=120 : 60 adults & 60 children)
Biological: Blood sampling
Blood sampling
Other: ECG-Holter 24 h tape and sino-carotid stimulation test
ECG-Holter 24 h tape and sino-carotid stimulation test
Subjects controls without vagal syncopes
Subjects controls without vagal syncopes (n=120:60 adults & 60 children
Biological: Blood sampling
Blood sampling
Other: ECG-Holter 24 h tape and sino-carotid stimulation test
ECG-Holter 24 h tape and sino-carotid stimulation test

  Eligibility

Ages Eligible for Study:   1 Month to 51 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

University Hospital

Criteria

Inclusion Criteria:

  • Man or woman aged 1 month to 50 years
  • Patients with clinical signs of recurrent severe vagal syncopes
  • Controls without clinical signs of recurrent severe vagal syncopes
  • Mandatory clinical examination prior to enrolment

Exclusion Criteria:

  • Autonomic nervous system disorders
  • Cardiovascular, neurologic, psychiatric or metabolic diseases
  • Drugs interfering with autonomic nervous system
  • Doping or drug abuse
  • Chronic smoking (more than 3 cigarettes a day
  • Pregnancy
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01358461

Locations
France
Hôpitaux Universitaires de Strasbourg Recruiting
Strasbourg, France, 67000
Contact: Pascal BOUSQUET    0033369550618    cic@chru-strasbourg.fr   
Principal Investigator: Angelo LIVOLSI         
Sub-Investigator: Pauline HELMS         
Principal Investigator: Pascal BOUSQUET         
Principal Investigator: Gerald ROUL         
Sub-Investigator: Catherine MUTTER         
Sub-Investigator: Hubert MAISONNEUVE         
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
Principal Investigator: Angelo LIVOLSI Hôpitaux Universitaires de Strasbourg
  More Information

No publications provided

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT01358461     History of Changes
Other Study ID Numbers: 4900 (2010 - A01451-38)
Study First Received: May 20, 2011
Last Updated: June 14, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

ClinicalTrials.gov processed this record on September 16, 2014