International Study on Syncope of Uncertain Etiology

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00120094
Recruitment Status : Terminated
First Posted : July 15, 2005
Last Update Posted : April 11, 2006
Information provided by:
Arcispedale Santa Maria Nuova-IRCCS

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.

Condition or disease

  Show Detailed Description

Study Type : Observational
Enrollment : 400 participants
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
Study Start Date : June 2002
Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fainting

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00120094

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-IRCCS
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