SyncopeTRAUMANCT04832542

Implantable Loop Recorder in Traumatic Syncope

An observational study of Syncope, run by Azienda Ospedaliera Cardinale G. Panico.

Completed

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

Trial summary

Prospective, observational registry enrolling consecutive patients with recurrent, unexplained, traumatic syncope underwent implantable loop recorder implantation with the aim to evaluate the incidence of recurrence of traumatic syncope during follow-up. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Syncope
What is being tested?: outpatient follow-up
How many people: 488 participants
Where: No sites listed yet
Study dates: 1 Jan 2011to 31 Jan 2021
How long will I take part?: 24 Months
Phase: Observational
Are there results?: None posted in the registry

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 18 years and older
All sexes
Adult, Older adult

Study population: Consecutive patients with recurrent, unexplained, traumatic syncope underwent implantable loop recorder implantation

Who may be able to join

patients with recurrent, unexplained, traumatic syncope
patients underwent implantable loop recorder implantation

Who cannot join

patients unable to attend scheduled outpatient visits

About this study

Official title: Safety and Effectiveness of Implantable Loop Recorder in Patients With Recurrent, Unexplained, Traumatic Syncope

Read the detailed description

This observational, prospective registry enrolled consecutive patients with recurrent, unexplained, traumatic syncope underwent implantable loop recorder implantation according to current clinical practice. The patients were evaluated every 6 months based on current clinical practice and the risk of recurrence of traumatic syncope was assessed during follow-up.

Conditions: Syncope
Being tested: outpatient follow-up
Medical subject headings: Syncope

What participants receive

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

outpatient follow-upOther
The patients were evaluated every six months in order to assess the incidence of traumatic syncope recurrence during follow-up after implantable loop recorder implantation.

What is being measured

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

Traumatic syncope recurrence
Incidence of traumatic syncope recurrence
Measured: through study completion, an average of 2 year

Timeline

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

1 Jan 201131 Jan 2021

First posted6 Apr 2021
Study start1 Jan 2011
Primary completion31 Dec 2020
Study completion31 Jan 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for SyncopeStudies of the same condition, open and under way.
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: 488 participants (actual)
Target duration: 24 Months

IDs, dates and publications

ClinicalTrials.gov ID: NCT04832542
Sponsor's protocol ID: TRAUMA
Acronym: TRAUMA
Status last verified: Apr 2021
First submitted: 1 Apr 2021
Last updated: 6 Apr 2021
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: 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

RecruitingObservational study
Whole-Body Point-of-Care Ultrasound in Older Adults Presenting to the Emergency Department After a Fall
Accidental Falls, Aged
Not yet recruiting
Head-to-Head (H2H) Comparison of Ambulatory Cardiac ECG Monitors in Japan
Atrial Fibrillation (AF), Atrial Flutter
RecruitingObservational study
Fainting Detection And Early Warning In Syncope Evaluation Study (ARISE)
Orthostatic Hypotension, Reflex Syncope
Active, not recruiting
Cardioneuroablation for Reflex Syncope and Exercise Capacity
Syncope, Vasovagal
RecruitingObservational study
Biospecimen Repository for Cardiac Arrhythmias at the Cleveland Clinic
Arrhythmias, Cardiac

All Syncope trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Effectiveness of Implantable Loop Recorder in Patients With Recurrent, Unexplained, Traumatic Syncope
ClinicalTrials.gov ID: NCT04832542
Acronym / sponsor ID: TRAUMA / TRAUMA
Conditions: Syncope
Study type: Observational
Recruitment status: Completed
Enrolment: 488 participants (actual)
Lead sponsor: Azienda Ospedaliera Cardinale G. PanicoUniversity, hospital or other
Collaborators: Università Politecnica delle Marche, University of Campania Luigi Vanvitelli, Azienda Ospedaliera Pugliese Ciaccio, Azienda Ospedaliero Universitaria Maggiore della Carita, Cardiology Department, Policlinico Riuniti University Hospital, Foggia, Italy, Cardiology Division, Villa Scassi Hospital, Genova ASL 3, Genova, San Giuseppe e Melorio Hospital, Santa Maria Capua Vetere, Nostra Signora di Bonaria Hospital, San Gavino Monreale, Istituto Nazionale di Ricovero e Cura per Anziani
Study start: 1 Jan 2011 (actual)
Primary completion: 31 Dec 2020 (actual)
Study completion: 31 Jan 2021 (actual)
First posted: 6 Apr 2021 (actual)
Results: Not posted in the source record

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
Target follow-up: 24 Months

Who may qualify

Ages: 18 years and older
Sex: All
Age groups: Adult, Older adult
Study population: Consecutive patients with recurrent, unexplained, traumatic syncope underwent implantable loop recorder implantation

Key inclusion criteria (2 listed)

patients with recurrent, unexplained, traumatic syncope
patients underwent implantable loop recorder implantation

Key exclusion criteria (1 listed)

patients unable to attend scheduled outpatient visits

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
outpatient follow-upThe patients were evaluated every six months in order to assess the incidence of traumatic syncope recurrence during follow-up after implantable loop recorder implantation.	Other	–

Primary outcome

Traumatic syncope recurrence
Time frame: through study completion, an average of 2 year
Incidence of traumatic syncope recurrence

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2021.
Individual participant dataSharing planned: No

Related trials for Syncope

RecruitingObservational study
Whole-Body Point-of-Care Ultrasound in Older Adults Presenting to the Emergency Department After a Fall
Accidental Falls, Aged
Not yet recruiting
Head-to-Head (H2H) Comparison of Ambulatory Cardiac ECG Monitors in Japan
Atrial Fibrillation (AF), Atrial Flutter
RecruitingObservational study
Fainting Detection And Early Warning In Syncope Evaluation Study (ARISE)
Orthostatic Hypotension, Reflex Syncope
Active, not recruiting
Cardioneuroablation for Reflex Syncope and Exercise Capacity
Syncope, Vasovagal
RecruitingObservational study
Biospecimen Repository for Cardiac Arrhythmias at the Cleveland Clinic
Arrhythmias, Cardiac

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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

An observational study of Syncope, run by Azienda Ospedaliera Cardinale G. Panico.

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 2 inclusion and 1 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 6 Apr 2021. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Traumatic syncope recurrence (time frame: through study completion, an average of 2 year). 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 NCT04832542.

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 6 Apr 2021.