Guideline-based Pacing Therapy for Reflex Syncope (SUP2)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Gruppo Italiano Multidisciplinare per lo Studio della Sincope
Sponsor:
Information provided by (Responsible Party):
Gruppo Italiano Multidisciplinare per lo Studio della Sincope
ClinicalTrials.gov Identifier:
NCT01509534
First received: December 5, 2011
Last updated: May 1, 2014
Last verified: May 2014
  Purpose

Study hypothesis: Dual-chamber pacemaker therapy with rate-hysteresis features is effective in preventing syncopal recurrences in patients affected by cardioinhibitory (CI) forms of reflex syncope diagnosed by means of carotid sinus massage, tilt table testing or implantable loop recorder (ILR). The outcome is measured either by the time to first syncopal recurrence or the total syncope burden.


Condition
Syncope

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Guideline-based Pacing Therapy for Reflex Syncope

Resource links provided by NLM:


Further study details as provided by Gruppo Italiano Multidisciplinare per lo Studio della Sincope:

Primary Outcome Measures:
  • syncope recurrence after PM implantation [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • syncope burden after PM implantation [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 700
Study Start Date: January 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Detailed Description:

Background Divergence of opinion exists regarding the efficacy of cardiac pacing in patients affected by different forms of reflex syncope.

Definitions.

Severe syncope is defined when:

  • it is perceived by patient that it alters his/her quality of life, and
  • is unpredictable because occurs without, or with very short prodromes < 10 sec (thus exposing patients to risk of trauma) or, if preceded by prodromes, syncope recurs despite appropriate therapies (CPM or drugs).

Recurrent syncopes: at least 2 episodes during the last year (including the index episode) or 3 episodes during the last 2 years (including the index episode).

Suspected (undetermined) reflex syncope: the suspicion of reflex syncope is based on a history of uncertain syncope in the absence of (i) severe structural heart disease, significant ECG abnormalities, or rhythm disturbances; (ii) orthostatic hypotension; and (iii) non-syncopal causes of transient loss of consciousness.

Study protocol

  1. The eligible patients undergo firstly carotid sinus massage (according to the method of symptoms); if a diagnosis of cardioinhibitory carotid sinus syndrome (CI-CSS) is made, a pacemaker is implanted and follow-up immediately starts.
  2. If the carotid sinus massage is negative or vasodepressor, the patients undergo tilt table testing (with nitroglycerin or clomipramine drug challenge); if a diagnosis of VASIS 2B form is made, a pacemaker is implanted and follow-up immediately starts.
  3. If tilt table testing is negative or a form different from VASIS 2B is induced, the patients undergo ILR implantation. If a diagnosis of asystolic reflex syncope is made, a pacemaker is implanted and follow-up immediately starts.

End-points End-point of the study is syncope recurrence after pacemaker (PM) implantation. Syncope is defined as complete transient loss of consciousness. Pre-syncope is counted but it is not an end-point.

Primary end-points:

  1. Comparison of the time to first syncopal recurrence in CI-CSS and CI-TTT pts with PM and in control patients with ILR.
  2. Intra-patient comparison of the syncope burden in the year before and in the year following PM implant in all patients receiving a PM (CCS, TTT and ILR groups). Index syncope is not counted.

Follow-up One year after PM implantation for all enrolled patients for burden of syncope end-points Until the study end for time to first syncope recurrence end-points. Thus, the study ends one year after the enrollment of the last patient.

Study size Based on the sample size calculation the study will stop when 700 patients are enrolled.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients affected by reflex syncopes

Criteria

Inclusion Criteria:

  • Patients affected by severe, recurrent, certain or suspected (undetermined) reflex syncopes, aged ≥ 40 years.

Exclusion Criteria:

  • Reflex syncopes due to reversible causes, e.g., vasoactive drugs, concomitant diseases, etc
  • Suspected of certain cardiac syncope
  • Syncope caused by orthostatic hypotension
  • Non-syncopal causes of transient loss of consciousness
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01509534

Contacts
Contact: Michele Brignole, MD 0185329569 mbrignole@ASL4.liguria.it
Contact: Carla Lucchetti, RN 0185329739 segreteria.cardio@ASL4.liguria.it

Locations
Italy
Ospedale Generale Regionale Recruiting
Bolzano, Italy
Contact: Marco Tomaino         
Principal Investigator: Marco Tomaino         
AO di Rilievo Nazionale e di Alta Specializzazione Garibaldi Recruiting
Catania, Italy
Contact: Michele Gulizia         
Principal Investigator: Michele Gulizia         
PO S. Giuseppe Recruiting
Empoli, Italy
Contact: Attilio Del Rosso         
Principal Investigator: Attilio Del Rosso         
AO Careggi Recruiting
Firenze, Italy
Contact: Andrea Ungar         
Principal Investigator: Andrea Ungar         
Nuovo Ospedale S. Giovanni di Dio Active, not recruiting
Firenze, Italy
Department of Cardiology, Ospedali del Tigullio Recruiting
Lavagna, Italy, 16033
Contact: Michele Brignole         
Principal Investigator: Michele Brignole         
Arcispedale S. Maria Nuova Recruiting
Reggio Emilia, Italy
Contact: Fabio Quartieri         
Principal Investigator: Fabio Quartieri         
Ospedale SS. Annunziata Recruiting
Taranto, Italy
Contact: Vitantonio Russo         
Principal Investigator: Vitantonio Russo         
Sponsors and Collaborators
Gruppo Italiano Multidisciplinare per lo Studio della Sincope
Investigators
Principal Investigator: Michele Brignole, MD Ospedali del Tigullio, Lavagna, Italy
  More Information

No publications provided

Responsible Party: Gruppo Italiano Multidisciplinare per lo Studio della Sincope
ClinicalTrials.gov Identifier: NCT01509534     History of Changes
Other Study ID Numbers: GIMSI-001-2011
Study First Received: December 5, 2011
Last Updated: May 1, 2014
Health Authority: Italy: Ministry of Health

Keywords provided by Gruppo Italiano Multidisciplinare per lo Studio della Sincope:
pacemaker
implantable loop recorder
syncope

Additional relevant MeSH terms:
Syncope
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 10, 2014