SyncopeNCT04435262
Syncope and Implanted Loop Recorder: the Utility of Remote Monitoring and Patients Centered Setting Alarms
An observational study of Syncope and Loop Recorder, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
Trial summary
Actually, there are few data about the effectiveness of remote monitoring (RM) and patient centered alarms setting in patients with unexplained syncope underwent implanted loop recorder (ILR) monitoring. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Syncope, Loop Recorder, Remote Monitoring
- What is being tested?
- Remote Monitoring
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 10 May 2020to 16 Mar 2024
- 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 14 years and older
- All sexes
- Child, Adult, Older adult
Study population: The study population included all patients with unexplained syncope underwent ICM implantation according to current gudelines and followed by conventionally or RM according to the hospital's clinical practice.
Who may be able to join
- Patients with unexplained syncope underwent ICM implantation according to current gudelines.
Who cannot join
- Patients do not provied signing Patient Informed Consent Form
Trial locations and contacts
1 site in 1 country.
Vincenzo Russo contact
Italy1 site, 1 recruiting
- Recruiting
University of Campania "Luigi Vanvitelli"
Naples
Vincenzo Russo, vincenzo.russo@unicampania.it
Vincenzo Russo
About this study
Official title: Syncope and Implanted Loop Recorder: the Utility of Remote Monitoring and Patients Centered Setting Alarms in Real World Setting.
Actually, there are few data about the effectiveness of remote monitoring (RM) and patient centered alarms setting in patients with unexplained syncope underwent implanted loop recorder (ILR) monitoring.
The aim of this study is to evaluate the time from onset of first physician's evaluation of asyntomatic ECG events lead to medical treatment in ordinary clinical practice for syncope patients with ILR patients and compare it between patients followed with RM or conventionally with annual in-hospital visits.
- Conditions
- Syncope, Loop Recorder, Remote Monitoring
- Being tested
- Remote Monitoring
- Keywords
- Syncope, Loop Recorder, Remote Monitoring
- Medical subject headings
- Syncope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote MonitoringOther
Remote Monitoring Follow-up
| Study group | Role | What they receive |
|---|---|---|
| ILR Group followed with RM | Patients with unexplained syncope underwent ILR monitoring and followed with RM Receives: Other: Remote Monitoring | |
| ILR Group followed with in-hospital visits | Patients with unexplained syncope underwent ILR monitoring and followed with in-hospital visits |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to medical treatment
Time from onset of first physician's evaluation of asyntomatic ECG events lead to medical treatment in ordinary clinical practice for syncope patients with ILR patients and compare it between patients followed with RM or conventionally with annual in-hospital visits.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2020
- Study start10 May 2020
- Primary completion16 Mar 2022 (estimated)
- Study completion16 Mar 2024 (estimated)
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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vincenzo Russo, University of Campania Luigi Vanvitelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04435262
- Sponsor's protocol ID
- 181060320
- Status last verified
- Aug 2021
- First submitted
- 10 Jun 2020
- Last updated
- 17 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Syncope and Implanted Loop Recorder: the Utility of Remote Monitoring and Patients Centered Setting Alarms in Real World Setting.
- ClinicalTrials.gov ID
- NCT04435262
- Acronym / sponsor ID
- 181060320
- Conditions
- Syncope, Loop Recorder, Remote Monitoring
- Keywords
- Syncope, Loop Recorder, Remote Monitoring
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Study start
- 10 May 2020 (actual)
- Primary completion
- 16 Mar 2022 (estimated)
- Study completion
- 16 Mar 2024 (estimated)
- First posted
- 17 Jun 2020 (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.
Actually, there are few data about the effectiveness of remote monitoring (RM) and patient centered alarms setting in patients with unexplained syncope underwent implanted loop recorder (ILR) monitoring.
The aim of this study is to evaluate the time from onset of first physician's evaluation of asyntomatic ECG events lead to medical treatment in ordinary clinical practice for syncope patients with ILR patients and compare it between patients followed with RM or conventionally with annual in-hospital visits.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ILR Group followed with RM | – | Other: Remote MonitoringPatients with unexplained syncope underwent ILR monitoring and followed with RM |
| ILR Group followed with in-hospital visits | – | –Patients with unexplained syncope underwent ILR monitoring and followed with in-hospital visits |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- The study population included all patients with unexplained syncope underwent ICM implantation according to current gudelines and followed by conventionally or RM according to the hospital's clinical practice.
Key inclusion criteria (1 listed)
- Patients with unexplained syncope underwent ICM implantation according to current gudelines.
Key exclusion criteria (1 listed)
- Patients do not provied signing Patient Informed Consent Form
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 |
|---|---|---|
| Remote MonitoringRemote Monitoring Follow-up | Other | ILR Group followed with RM |
Primary outcome
Time to medical treatment
Time frame: through study completion, an average of 1 year
Time from onset of first physician's evaluation of asyntomatic ECG events lead to medical treatment in ordinary clinical practice for syncope patients with ILR patients and compare it between patients followed with RM or conventionally with annual in-hospital visits.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2021.
- Individual participant dataSharing planned: Undecided
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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.
Vincenzo Russo contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Syncope and Loop Recorder, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
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 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: status not confirmed, as of the sponsor's last update on 17 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vincenzo Russo, MD PhD (0817062355, vincenzo.russo@unicampania.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to medical treatment (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Aug 2021.