Vascular RingNCT04781738
Functional Capacity and Quality of Life in Patients With Vascular Ring
An observational study of Vascular Ring, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
To investigate the long term functional capacity and quality of life of patients with a history of vascular ring whether they did or did not have corrective surgery. Patients will perform pulmonary function test, 6 minute walk test, cardiopulmonary exercise test and will fill a quality of life questionnaire. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Vascular Ring
- What is being tested?
- Cardiopulmonary exercise test
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- 15 Mar 2018to Feb 2022
- 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 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with history of vascualr ring
Who may be able to join
- patients with history of vascular ring
Who cannot join
- refusal to participate
- inability to complete cardiopulmonary testing
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Rambam health care campus
Haifa
Lea Bentur, Prof., 972-4-777-4360, l_bentur@rambam.health.gov.il
About this study
To investigate the long term functional capacity and quality of life of patients with a history of vascular ring whether they did or did not have corrective surgery. Patients will perform pulmonary function test, 6 minute walk test, cardiopulmonary exercise test and will fill a quality of life questionnaire.
Read the detailed description
Vascular rings are congenital vascular anomalies of the aortic arch that compress the esophagus and the trachea. The most common vascular rings are double aortic arch and right aortic arch with left ligamentum. Pulmonary artery sling is less common. Another cause of tracheal compression occurring only in infants is the innominate artery compression syndrome. When patients are symptomatic, surgical correction should be performed.
data regarding long term functional capacity and quality of life is lacking. our aim is to investigate the long term functional capacity and quality of life of patients with history of vascular ring whether they did or did not have corrective surgery.
Methods: a prospective study evaluating functional capacity and quality of life the patients will perform pulmonary function test, 6 minute walk test, cardiopulmonary exercise test and will fill a quality of life questionnaire (sf-36).
- Conditions
- Vascular Ring
- Being tested
- Cardiopulmonary exercise test
- Keywords
- Cardiopulmonary exercise testing,, Double aortic arch
- Medical subject headings
- Vascular Ring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiopulmonary exercise testDiagnostic test
Also called 6 minute walk test, quality of life questionnaire (sf-36)
CPET using a cycle ergometer (COSMED, Rome, Italy) beginning with no resistance warmup lasting 1-3 minutes followed with an incrementing resistance adapted to the patient's functional capacities according to the examiner's free judgment by successive stages
Six minute walk test - patients will be instructed to walk as far as possible for six minutes in a 30-meter long enclosed corridor with a flat and hard surface, marked at every meter. Meters will be calculated at the end of the test.
SF-36 is a questionnaire that contains eight domains - physical functioning (10 items); role limitations due to physical functioning (4 items); role limitations due to emotional problems (3 items); energy and vitality (4 items); mental health (5 items); social functioning (2 items); bodily pain (2 items); and general health perceptions (5 items).
Scores are summed for each domain and were transformed into scores of between 0 (worst possible health state) to 100 (best possible health state).
| Study group | Role | What they receive |
|---|---|---|
| patients with history of vascular ring who didn't have corrective surgery | patients with history of vascular ring who didn't have corrective surgery Receives: Diagnostic Test: Cardiopulmonary exercise test | |
| patients with history of vascular ring who underwent corrective surgery | patients with history of vascular ring who underwent corrective surgery Receives: Diagnostic Test: Cardiopulmonary exercise test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise capacity
Oxygen uptake evaluated by cardiopulmonary exercise testing (CPET)
Measured: Measured continuously during 15 minutes of the exercise test (CPET)
Secondary outcomes (2)
Six minute walk test
The distance gained after six minute of habitual walking.
Measured: Six minutes of evaluation, completed pre cardiopulmonary exercise test (CPET)
Quality of life - SF-36
The calculated result of SF-36 questionnaire
Measured: Five minutes of evaluation, completed pre cardiopulmonary exercise test (CPET)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start15 Mar 2018
- Primary completionDec 2021 (estimated)
- Study completionFeb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vascular RingStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, l_bentur, Rambam Health Care Campus
- Investigators
- Lea Bentur, MD, Principal investigator, Head of Pediatric Pulmonary Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04781738
- Sponsor's protocol ID
- RMB-0218-17
- Status last verified
- Feb 2021
- First submitted
- 21 Feb 2021
- Last updated
- 4 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nir V, Bentur L, Zucker-Toledano M, Gur M, Adler Z, Hanna M, Toukan Y, Masarweh K, Hakim F, Bar-Yoseph R. Functional capacity and quality of life in patients with vascular ring. Pediatr Pulmonol. 2022 Dec;57(12):2946-2953. doi: 10.1002/ppul.26112. Epub 2022 Sep 14.
PubMed 35971243
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Capacity and Quality of Life in Patients With Vascular Ring
- ClinicalTrials.gov ID
- NCT04781738
- Acronym / sponsor ID
- RMB-0218-17
- Conditions
- Vascular Ring
- Keywords
- Cardiopulmonary exercise testing,, Double aortic arch
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 15 Mar 2018 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Feb 2022 (estimated)
- First posted
- 4 Mar 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.
To investigate the long term functional capacity and quality of life of patients with a history of vascular ring whether they did or did not have corrective surgery. Patients will perform pulmonary function test, 6 minute walk test, cardiopulmonary exercise test and will fill a quality of life questionnaire.
Detailed description
Vascular rings are congenital vascular anomalies of the aortic arch that compress the esophagus and the trachea. The most common vascular rings are double aortic arch and right aortic arch with left ligamentum. Pulmonary artery sling is less common. Another cause of tracheal compression occurring only in infants is the innominate artery compression syndrome. When patients are symptomatic, surgical correction should be performed.
data regarding long term functional capacity and quality of life is lacking. our aim is to investigate the long term functional capacity and quality of life of patients with history of vascular ring whether they did or did not have corrective surgery.
Methods: a prospective study evaluating functional capacity and quality of life the patients will perform pulmonary function test, 6 minute walk test, cardiopulmonary exercise test and will fill a quality of life questionnaire (sf-36).
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with history of vascular ring who didn't have corrective surgery | – | Diagnostic Test: Cardiopulmonary exercise testpatients with history of vascular ring who didn't have corrective surgery |
| patients with history of vascular ring who underwent corrective surgery | – | Diagnostic Test: Cardiopulmonary exercise testpatients with history of vascular ring who underwent corrective surgery |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with history of vascualr ring
Key inclusion criteria (1 listed)
- patients with history of vascular ring
Key exclusion criteria (2 listed)
- refusal to participate
- inability to complete cardiopulmonary testing
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 |
|---|---|---|
| Cardiopulmonary exercise testAlso: 6 minute walk test, quality of life questionnaire (sf-36)CPET using a cycle ergometer (COSMED, Rome, Italy) beginning with no resistance warmup lasting 1-3 minutes followed with an incrementing resistance adapted to the patient's functional capacities according to the examiner's free judgment by successive stages Six minute walk test - patients will be instructed to walk as far as possible for six minutes in a 30-meter long enclosed corridor with a flat and hard surface, marked at every meter. Meters will be calculated at the end of the test. SF-36 is a questionnaire that contains eight domains - physical functioning (10 items); role limitations due to physical functioning (4 items); role limitations due to emotional problems (3 items); energy and vitality (4 items); mental health (5 items); social functioning (2 items); bodily pain (2 items); and general health perceptions (5 items). Scores are summed for each domain and were transformed into scores of between 0 (worst possible health state) to 100 (best possible health state). | Diagnostic test | patients with history of vascular ring who didn't have corrective surgery, patients with history of vascular ring who underwent corrective surgery |
Primary outcome
Exercise capacity
Time frame: Measured continuously during 15 minutes of the exercise test (CPET)
Oxygen uptake evaluated by cardiopulmonary exercise testing (CPET)
2 secondary outcomes
Six minute walk test
Time frame: Six minutes of evaluation, completed pre cardiopulmonary exercise test (CPET)
Quality of life - SF-36
Time frame: Five minutes of evaluation, completed pre cardiopulmonary exercise test (CPET)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2021.
- Derived from this study: PubMed 35971243Nir V, Bentur L, Zucker-Toledano M, Gur M, Adler Z, Hanna M, Toukan Y, Masarweh K, Hakim F, Bar-Yoseph R. Functional capacity and quality of life in patients with vascular ring. Pediatr Pulmonol. 2022 Dec;57(12):2946-2953. doi: 10.1002/ppul.26112. Epub 2022 Sep 14.
- Individual participant dataSharing planned: No
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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.
Lea Bentur, MD principal investigator
Head of Pediatric Pulmonary Institute
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 Vascular Ring, run by Rambam Health Care Campus at 1 site in Israel.
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: status not confirmed, as of the sponsor's last update on 4 Mar 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 Israel. 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 Lea Bentur, MD (+972-4-7774360, l_bentur@rambam.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise capacity (time frame: Measured continuously during 15 minutes of the exercise test (CPET)). 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 NCT04781738, which also lists 1 linked publication.
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 4 Mar 2021.