Trial Outcomes & Findings for Applicability of Syncope Guidelines in Cataluña (NCT NCT01721369)

Results Overview

To analyze the number of patients that an etiologic diagnose was established according to the New Syncope Guidelines ESC2009 in the hospital care, in a particular community with hospitals with different levels of care in a specific region of Spain.

Recruitment status

COMPLETED

Target enrollment

581 participants

Primary outcome timeframe

12 months

Results posted on

2025-07-02

Participant Flow

Participant milestones

Participant milestones
Measure	Transient Loss of Consciousness (T-LOC) Patient with transient loss of consciousness (T-LOC)
Overall Study STARTED	581
Overall Study COMPLETED	569
Overall Study NOT COMPLETED	12

Reasons for withdrawal

Reasons for withdrawal
Measure	Transient Loss of Consciousness (T-LOC) Patient with transient loss of consciousness (T-LOC)
Overall Study Not initial etiological diagnosis	12

Baseline Characteristics

Applicability of Syncope Guidelines in Cataluña

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Transient Loss of Consciousness (T-LOC) n=581 Participants Patients with transient loss of consciousness (T-LOC)
Age, Categorical <=18 years	9 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	214 Participants n=5 Participants
Age, Categorical >=65 years	358 Participants n=5 Participants
Sex: Female, Male Female	253 Participants n=5 Participants
Sex: Female, Male Male	328 Participants n=5 Participants
Region of Enrollment Spain	581 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Patients with transient loss of consciousness (T-LOC) from the emergency service and/or external clinic visits (Cardiology, Neurology, etc)

To analyze the number of patients that an etiologic diagnose was established according to the New Syncope Guidelines ESC2009 in the hospital care, in a particular community with hospitals with different levels of care in a specific region of Spain.

Outcome measures

Outcome measures
Measure	Transient Loss of Consciousness (T-LOC) n=569 Participants Patients with transient loss of consciousness (T-LOC)
Number of Patients That Adhere to the 2009 Syncope Guidelines (ESC2009)	233 Participants

Adverse Events

Transient Loss of Consciousness (T-LOC)

Serious events: 163 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Transient Loss of Consciousness (T-LOC) n=569 participants at risk Patient with transient loss of consciousness (T-LOC)
General disorders Life-threatening illness or injury	0.70% 4/569 • 1 year Serious adverse events (SAE) were recollect at 1 year follow up, other adverse events were not recollected in this observational study.
General disorders Hospitalization	21.6% 123/569 • 1 year Serious adverse events (SAE) were recollect at 1 year follow up, other adverse events were not recollected in this observational study.
General disorders Permanent insufficiency of a body structure or a body function	0.18% 1/569 • 1 year Serious adverse events (SAE) were recollect at 1 year follow up, other adverse events were not recollected in this observational study.
General disorders Death	6.2% 35/569 • 1 year Serious adverse events (SAE) were recollect at 1 year follow up, other adverse events were not recollected in this observational study.

Other adverse events

Adverse event data not reported

Additional Information

Dr. Angel Moya

Hospital Vall hebron

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place