International Study on Syncope of Uncertain Etiology - Full Text View

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

MedlinePlus related topics:

Fainting

U.S. FDA Resources

Study Type:	Observational
Study Design:	Screening, Longitudinal, Defined Population, Prospective Study

Official Title:	ISSUE 2. The Management of Patients With Suspected or Certain Neurally-Mediated Syncope After the Initial Evaluation

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
	Arcispedale S Maria Nuova
	Reggio Emilia, Italy

Italy, Genova
	Department of Cardiology, Arrhythmologic Centre
	Lavagna, Genova, Italy, 16033

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 of Results:

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]

Other Publications:

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.

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

Keywords provided by Arcispedale Santa Maria Nuova:

Syncope

Electrocardiographic monitoring

Study placed in the following topic categories:

Signs and Symptoms

Unconsciousness

Consciousness Disorders

Neurologic Manifestations

Neurobehavioral Manifestations

Syncope

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on September 05, 2008

Sponsors and Collaborators:	Arcispedale Santa Maria Nuova Medtronic
Information provided by:	Arcispedale Santa Maria Nuova
ClinicalTrials.gov Identifier:	NCT00120094