Transposition of Great ArteriesSTARNCT05690854
Cardiovascular Magnetic Resonance in Adults With SysTemic Right Ventricle (STAR)
An observational study of Transposition of Great Arteries, run by IRCCS Policlinico S. Donato at 1 site in Italy.
Trial summary
The main aim of the study is to explore HFs in SRV, comparing their magnitude and direction with that of subpulmonary RV and systemic LV. As a secondary aim, possible association or correlation will be investigated between SRV energetics and: i) patient functional parameters, e.g., the results from cardiopulmonary… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Transposition of Great Arteries
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 29 Nov 2022to 30 Jun 2025
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with diagnosis of L-loop transposition of great arteries (L-TGA) and D-loop transposition of great arteries (D-TGA) after atrial switch operation (ASO).
Who may be able to join
- The study will include patients aged ≥ 18 years with the diagnosis of L-TGA and D-TGA, who:
- are admitted to UNICCA, the Adult Congenital Heart Unit or
- are scheduled for a Cardiovascular Magnetic Resonance examination in this Institution
- Control group:
- The study will include subjects aged ≥ 18 years who will invited for a Cardiovascular Magnetic Resonance examination in our Institution. This group of control will include n=15 of adult healthy subjects. A further inclusion criteria for the control subjects are age and male proportion comparable to those of the TGA group.
Who cannot join
- (case and control group)
- Subjects with intrabody ferromagnetic material precluding subject's safety
- Subjects with non CMR-conditional devices
- Subjects with claustrophobia or breath-holding precluding an adequate CMR and 4D Flow images quality
- Pregnant women
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Policlinico San Donato
San Donato Milanese, Milano, 20097
Giulia Pasqualin, MD, +390252774502, giulia.pasqualin@grupposandonato.it
About this study
Official title: Cardiovascular Magnetic Resonance in Adults With SysTemic Right Ventricle (STAR): From Pathophysiology to Clinical Application
The main aim of the study is to explore HFs in SRV, comparing their magnitude and direction with that of subpulmonary RV and systemic LV. As a secondary aim, possible association or correlation will be investigated between SRV energetics and: i) patient functional parameters, e.g., the results from cardiopulmonary exercise test (CPET), ii) patient clinical status, including the occurrence of adverse outcome (a composite of death, hospitalization for heart failure, cardiovascular arrest, sustained arrhythmias).
- Conditions
- Transposition of Great Arteries
- Medical subject headings
- Transposition of Great Vessels
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Case | The study will include patients aged ≥ 18 years with the diagnosis of L-TGA and D-TGA, who: * are admitted to IRCCS Policlinico San Donato, the Adult Congenital Heart Unit or * are scheduled for a Cardiovascular Magnetic Resonance examination in this Institution | |
| Control | The study will include subjects aged ≥ 18 years who will invited for a Cardiovascular Magnetic Resonance examination in our Institution. This group of control will include n=15 of adult healthy subjects. A further inclusion criteria for the control subjects are age and male proportion comparable to those of the TGA group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Outcome definition
A composite of death, hospitalizations for heart failure, cardiovascular arrest, sustained arrhythmias (≥30 seconds).
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start29 Nov 2022
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transposition of Great ArteriesStudies of the same condition, open and under way.
- More trials run by IRCCS Policlinico S. DonatoThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Policlinico S. Donato
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giulia Pasqualin, IRCCS Policlinico S. Donato
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05690854
- Sponsor's protocol ID
- STAR
- Acronym
- STAR
- Status last verified
- Jan 2023
- First submitted
- 10 Jan 2023
- Last updated
- 25 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Magnetic Resonance in Adults With SysTemic Right Ventricle (STAR): From Pathophysiology to Clinical Application
- ClinicalTrials.gov ID
- NCT05690854
- Acronym / sponsor ID
- STAR / STAR
- Conditions
- Transposition of Great Arteries
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- IRCCS Policlinico S. DonatoUniversity, hospital or other
- Study start
- 29 Nov 2022 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 19 Jan 2023 (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.
The main aim of the study is to explore HFs in SRV, comparing their magnitude and direction with that of subpulmonary RV and systemic LV. As a secondary aim, possible association or correlation will be investigated between SRV energetics and: i) patient functional parameters, e.g., the results from cardiopulmonary exercise test (CPET), ii) patient clinical status, including the occurrence of adverse outcome (a composite of death, hospitalization for heart failure, cardiovascular arrest, sustained arrhythmias).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | – | –The study will include patients aged ≥ 18 years with the diagnosis of L-TGA and D-TGA, who: * are admitted to IRCCS Policlinico San Donato, the Adult Congenital Heart Unit or * are scheduled for a Cardiovascular Magnetic Resonance examination in this Institution |
| Control | – | –The study will include subjects aged ≥ 18 years who will invited for a Cardiovascular Magnetic Resonance examination in our Institution. This group of control will include n=15 of adult healthy subjects. A further inclusion criteria for the control subjects are age and male proportion comparable to those of the TGA group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with diagnosis of L-loop transposition of great arteries (L-TGA) and D-loop transposition of great arteries (D-TGA) after atrial switch operation (ASO).
Key inclusion criteria (5 listed)
- The study will include patients aged ≥ 18 years with the diagnosis of L-TGA and D-TGA, who:
- are admitted to UNICCA, the Adult Congenital Heart Unit or
- are scheduled for a Cardiovascular Magnetic Resonance examination in this Institution
- The study will include subjects aged ≥ 18 years who will invited for a Cardiovascular Magnetic Resonance examination in our Institution. This group of control will include n=15 of adult healthy subjects. A further inclusion criteria for the control subjects are age and male proportion comparable to those of the TGA group.
Key exclusion criteria (5 listed)
- (case and control group)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Adverse Outcome definition
Time frame: 5 years
A composite of death, hospitalizations for heart failure, cardiovascular arrest, sustained arrhythmias (≥30 seconds).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
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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.
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 Transposition of Great Arteries, run by IRCCS Policlinico S. Donato 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 5 inclusion and 5 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 25 Jan 2023. 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 Giulia Pasqualin, MD (+390252774502, giulia.pasqualin@grupposandonato.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Outcome definition (time frame: 5 years). 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 25 Jan 2023.