Brief Loss of ConsciousnessSYNCATNCT01721369

Applicability of Syncope Guidelines in Cataluña

An observational study of Brief Loss of Consciousness, run by Medtronic Cardiac Rhythm and Heart Failure.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The aim of SYNCAT study is to study the level of adherence of the centers in Cataluña tu the Syncope Guidelines ESC2009 for the diagnosis and treatment of syncope and the impact that following them can have in the prognosis of these patients. Read more about this study

Who is it for?: Ages 15 years and older
Conditions the study is for: Brief Loss of Consciousness
What is being tested?: Transient Loss of Consciousness (T-LOC)
How many people: 581 participants
Where: No sites listed yet
Study dates: Nov 2011to Mar 2013
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 15 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Patients with Transient Loss of Conscience: T-LOC

Who may be able to join

Each patient that comes from the Emergency room and/or in office doctors visit (Internal Medicine, Cardiology, Neurology...) with Transient Loss of Conscience (T-LOC)

Who cannot join

Patients younger than 15 years old
Pregnant women

About this study

Official title: Observational Study of the Application of the ESC2009 Syncope Guidelines in Cataluña

Read the detailed description

The aim of SYNCAT study is to analyze the level of adherence of Syncope Guidelines ESC2009 for the management, diagnosis and treatment of syncope in a specific territory with similar health structure, the region of Cataluña in Spain that includes aprox. 7,000,000 inhabitants, including different complexity level of hospitals and the impact that following guidelines can have in the prognosis of these patients.

Conditions: Brief Loss of Consciousness
Being tested: Transient Loss of Consciousness (T-LOC)
Keywords: TLOC

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Transient Loss of Consciousness (T-LOC)Diagnostic test

Study groups in NCT01721369
Study group	Role	What they receive
Transient Loss of Consciousness (T-LOC)		Transient Loss of Consciousness (T-LOC). Treatment according to normal clinical practice. Receives: Diagnostic Test: Transient Loss of Consciousness (T-LOC)

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Patients That Adhere to the 2009 Syncope Guidelines (ESC2009)
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.
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2011Mar 2013

First posted5 Nov 2012 (estimated)
Study startNov 2011
Primary completionMar 2013
Study completionMar 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Brief Loss of ConsciousnessStudies of the same condition, open and under way.
More trials run by Medtronic Cardiac Rhythm and Heart FailureThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 581 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01721369
Sponsor's protocol ID: SYNCAT
Acronym: SYNCAT
Status last verified: Sep 2020
First submitted: 19 Jun 2012
Last updated: 2 Jul 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Brief Loss of Consciousness trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Observational Study of the Application of the ESC2009 Syncope Guidelines in Cataluña
ClinicalTrials.gov ID: NCT01721369
Acronym / sponsor ID: SYNCAT / SYNCAT
Conditions: Brief Loss of Consciousness
Keywords: TLOC
Study type: Observational
Recruitment status: Completed
Enrolment: 581 participants (actual)
Lead sponsor: Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
Study start: Nov 2011
Primary completion: Mar 2013 (actual)
Study completion: Mar 2013 (actual)
First posted: 5 Nov 2012 (estimated)
Results: Posted 22 Sep 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Transient Loss of Consciousness (T-LOC)	–	Diagnostic Test: Transient Loss of Consciousness (T-LOC)Transient Loss of Consciousness (T-LOC). Treatment according to normal clinical practice.

Who may qualify

Ages: 15 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Patients with Transient Loss of Conscience: T-LOC

Key inclusion criteria (1 listed)

Each patient that comes from the Emergency room and/or in office doctors visit (Internal Medicine, Cardiology, Neurology...) with Transient Loss of Conscience (T-LOC)

Key exclusion criteria (2 listed)

Patients younger than 15 years old
Pregnant women

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Transient Loss of Consciousness (T-LOC)	Diagnostic test	Transient Loss of Consciousness (T-LOC)

Primary outcome

Number of Patients That Adhere to the 2009 Syncope Guidelines (ESC2009)
Time frame: 12 months
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.

Results and safety

Results posted to the registry on 22 Sep 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Transient Loss of Consciousness (T-LOC)	581	569

Primary outcome: Number of Patients That Adhere to the 2009 Syncope Guidelines (ESC2009)

Time frame: 12 months. Count of participants. Unit: Participants

Measure	Transient Loss of Consciousness (T-LOC) n = 569
Value	233

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

Adverse events

Time frame: 1 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Transient Loss of Consciousness (T-LOC)	163 of 569 (28.6%)	0 of 0	Not reported

Limitations and caveats (from the sponsor): Observational study

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Brief Loss of Consciousness

Active, not recruiting
Intervention to Change Affect Recognition and Empathy
Traumatic Brain Injury, Concussion, Intermediate
Not yet recruitingObservational study
Safety and Outcomes of MUSE Stem Cell Therapy in Individuals With Traumatic Brain Injury
Traumatic Brain Injury, Traumatic Brain Injury (TBI) Patients
RecruitingObservational study
Acutelines: a Large Data-/Biobank of Acute and Emergency Medicine
Acute Disease, Sepsis
Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Angel Moya, Dr. principal investigator

Hospital Vall d'Hebron

Jordi Tomàs, Dr. principal investigator

H. Arnau de Vilanova de Lleida

Joan Nicolàs, Dr. principal investigator

Parc Sanitari Sant Joan de Déu

Questions about this trial

What is this clinical trial studying?

An observational study of Brief Loss of Consciousness, run by Medtronic Cardiac Rhythm and Heart Failure.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients That Adhere to the 2009 Syncope Guidelines (ESC2009) (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01721369.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2025.