International Study on Syncope of Uncertain Etiology

NCT00120094 | Terminated

• 1 other identifier: ISS2
• Study Type: observational
• Target: 400
• Locations: 2 countries
• Sites: 3

Brief Summary

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.

Conditions

Syncope

Keywords

Syncope; Electrocardiographic monitoring

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Suspected or certain neurally-mediated syncope, based on the Guidelines of the ESC TF on Syncope.
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda USL Reggio Emilia - IRCCS: lead
• Medtronic: collaborator

Study Sites (3)

Department of Cardiology, Arrhythmologic Centre

Lavagna, Genova, 16033, Italy

Location

Arcispedale S Maria Nuova

Reggio Emilia, Reggio Emilia, Italy

Location

Royal Brompton Hospital

London SW3 6NP, United Kingdom

Location

Related Publications (2)

• 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. doi: 10.1016/s1099-5129(03)00048-5.

  PMID: 12842651 BACKGROUND

• Brignole M, Sutton R, Menozzi C, Garcia-Civera R, Moya A, Wieling W, Andresen D, Benditt DG, Vardas P; International Study on Syncope of Uncertain Etiology 2 (ISSUE 2) Group. Early application of an implantable loop recorder allows effective specific therapy in patients with recurrent suspected neurally mediated syncope. Eur Heart J. 2006 May;27(9):1085-92. doi: 10.1093/eurheartj/ehi842. Epub 2006 Mar 28.

  PMID: 16569653 RESULT

MeSH Terms

Conditions

Syncope

Condition Hierarchy (Ancestors)

Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: DEFINED POPULATION
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: June 30, 2005
• First Posted: July 15, 2005
• Study Start: June 1, 2002
• Study Completion: June 1, 2005
• Last Updated: April 11, 2006

Record last verified: 2005-07

Locations

IT (2); GB (1)