Back to resultsElectrophysiological Mechanisms and Inhibitory Cardiac Syncope (ELICA)
Primary Purpose
Syncope Recurrent
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
pacemaker
Sponsored by
About this trial
This is an interventional prevention trial for Syncope Recurrent
Eligibility Criteria
Inclusion Criteria:
- age more than 18, normal heart function, more than 1 syncope event for year.
Exclusion Criteria:
- age inferior 18 years, history of myocardial infarction, heart failure, structural heart disease.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
electrophysiological testing
control group
Arm Description
Patients will receive a pacemaker.
These subjects will receive cardicor® (beta blockers).
Outcomes
Primary Outcome Measures
syncope recurrence
Secondary Outcome Measures
Full Information
NCT ID
NCT02861274
First Posted
August 1, 2016
Last Updated
August 5, 2016
Sponsor
University of Campania "Luigi Vanvitelli"
1. Study Identification
Unique Protocol Identification Number
NCT02861274
Brief Title
Electrophysiological Mechanisms and Inhibitory Cardiac Syncope
Acronym
ELICA
Official Title
ELectrophysiological Mechanisms Underlying the Inhibitory CArdiac Syncope: Therapeutic and Prognostic Implications The ELICA Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Campania "Luigi Vanvitelli"
4. Oversight
5. Study Description
Brief Summary
OBJECTIVES: To evaluate syncope recurrence at follow up in patients with a positive cardio inhibitory response to the head up tilt testing (HUT) evaluation.
METHODS: 36 consecutive patients affected by cardio inhibitory syncope to HUT without asystolia (2A type) have been enrolled in this study. These patients have been studied by electrophysiological study (ES). After ES patients have been differently treated (interventional treatment group A, v/s drug therapy group), and followed up during 360 days, to evaluate syncope recurrences.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Syncope Recurrent
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
electrophysiological testing
Arm Type
Active Comparator
Arm Description
Patients will receive a pacemaker.
Arm Title
control group
Arm Type
No Intervention
Arm Description
These subjects will receive cardicor® (beta blockers).
Intervention Type
Device
Intervention Name(s)
pacemaker
Primary Outcome Measure Information:
Title
syncope recurrence
Time Frame
360 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age more than 18, normal heart function, more than 1 syncope event for year.
Exclusion Criteria:
age inferior 18 years, history of myocardial infarction, heart failure, structural heart disease.
12. IPD Sharing Statement
Citations:
PubMed Identifier
30075596
Citation
Sardu C, Marfella R, Testa G, Santamaria M, Sacra C, Ranauro A, Paolisso G, Rizzo MR, Barbieri M. ELectrophysiological mechanisms underlying the Inhibitory CArdiac syncope without asystolic significant pause: Therapeutic and prognostic implications. The ELICA randomized trial. Medicine (Baltimore). 2018 Aug;97(31):e11757. doi: 10.1097/MD.0000000000011757.
Results Reference
derived
Learn more about this trial
Electrophysiological Mechanisms and Inhibitory Cardiac Syncope
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