International Study on Syncope of Uncertain Etiology - Full Text View

Sponsor:	Arcispedale Santa Maria Nuova
Collaborator:	Medtronic
Information provided by:	Arcispedale Santa Maria Nuova
ClinicalTrials.gov Identifier:	NCT00120094

Purpose

This is a multi-center, prospective, observational study enrolling 400 patients with suspected or certain neurally-mediated syncope, who undergo carotid sinus massage, tilt testing and Implantable Loop Recorder (ILR)implantation. In its second phase, which starts after the first ILR-documented syncope, the study will register the patient outcome after administration of ILR-guided therapy, which is left to the discretion of the physicians. The main objective is to verify the value of ILR in assessing the mechanism of syncope and the efficacy of the ILR-guided therapy after syncope recurrence.

Condition	Phase
Syncope	Phase IV

Study Type:	Observational
Study Design:	Observational Model: Defined Population Primary Purpose: Screening Time Perspective: Longitudinal Time Perspective: Prospective
Official Title:	ISSUE 2. The Management of Patients With Suspected or Certain Neurally-Mediated Syncope After the Initial Evaluation

Resource links provided by NLM:

MedlinePlus related topics: Fainting

U.S. FDA Resources

Further study details as provided by Arcispedale Santa Maria Nuova:

Estimated Enrollment:	400
Study Start Date:	June 2002
Estimated Study Completion Date:	June 2005

Show Detailed Description

Eligibility

Ages Eligible for Study:	30 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Suspected or certain neurally-mediated syncope, based on the Guidelines of the ESC TF on Syncope.
3 syncope episodes in the last 2 years.
Severe clinical presentation of syncope requiring treatment initiation in the judgement of the investigator.
Age >30 years.
Patients have undergone carotid sinus massage, and ILR implantation.

Exclusion Criteria:

ILR not implanted for any reason; in this case, the patients are still followed in the ILR-not implanted group.
Carotid sinus syndrome.
Suspected or certain cardiac syncope.
Symptomatic orthostatic hypotension diagnosed by standing blood pressure measurement.
Loss of consciousness different from syncope (e.g. epilepsy, psychiatric, metabolic, drop-attack, TIA, intoxication, cataplexy).
Steal syndrome.
Psychologically or physically (due to any other illness) unfit for participation in the study according to the opinion of the investigator.
Patient compliance doubtful.
Patients who are geographically or otherwise inaccessible for follow-up.
Patient unwilling or unable to give informed consent;
Pregnancy.
Life expectancy < 1 year due to non-cardiac cause

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00120094

Locations

Italy
Department of Cardiology, Arrhythmologic Centre
Lavagna, Genova, Italy, 16033
Arcispedale S Maria Nuova
Reggio Emilia, Italy
United Kingdom
Royal Brompton Hospital
London SW3 6NP, United Kingdom

Sponsors and Collaborators

Arcispedale Santa Maria Nuova

Medtronic

Investigators

Principal Investigator:	Carlo Menozzi, MD	Department of Interventional Cardiology, Opsedle S Maria Nuova, Reggio Emilia
Principal Investigator:	Michele Brignole, MD	Department of Cardiology, Arrhythmologic Centre, Ospedali del Tigullio, Lavagna
Principal Investigator:	Richard Sutton, MD	Royal Brompton & National Heart Hospital, London

More Information

Publications:

Brignole M, Sutton R, Menozzi C, Garcia-Civera R, Moya A, Wieling W, Andresen D, Benditt DG, Vardas P. Early application of an implantable loop recorder allows effective specific therapy in patients with recurrent suspected neurally mediated syncope. Eur Heart J. 2006 Mar 28; [Epub ahead of print]

Steering Committee of the ISSUE 2 study. International Study on Syncope of Uncertain Etiology 2: the management of patients with suspected or certain neurally mediated syncope after the initial evaluation rationale and study design. Europace. 2003 Jul;5(3):317-21. Review.

ClinicalTrials.gov Identifier:	NCT00120094 History of Changes
Other Study ID Numbers:	ISS2
Study First Received:	June 30, 2005
Last Updated:	April 10, 2006
Health Authority:	United Kingdom: National Health Service

Keywords provided by Arcispedale Santa Maria Nuova:

Syncope
Electrocardiographic monitoring

Additional relevant MeSH terms:

Syncope
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations

Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on February 12, 2012