Syncope Recurrent Clinical Trial
— ELICAOfficial title:
ELectrophysiological Mechanisms Underlying the Inhibitory CArdiac Syncope: Therapeutic and Prognostic Implications The ELICA Study
| Verified date | August 2016 |
| Source | Second University of Naples |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Italy: Ministry of Health |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 36 |
| Est. completion date | September 2015 |
| Est. primary completion date | January 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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. |
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Second University of Naples |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | syncope recurrence | 360 days | Yes |