Pulmonary Arterial HypertensionNCT03105934
Repeatability of OCT and IV-US in Pulmonary Arterial Hypertension
A study testing Patients with Pulmonary Arterial Hypertension in people with Pulmonary Arterial Hypertension, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
Trial summary
To assess the correlation between pulmonary IV-OCT and pulmonary IV-US measurements and standard PAH clinical measures of disease progression and the relative sensitivity of the techniques to change. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- Patients with Pulmonary Arterial Hypertension
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2016to 25 Jan 2018
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- With confirmed diagnosis of PAH Group 1 according to the ESC/ERS Guidelines
- With severe disease, defined as Class II- III of the modified WHO functional classes in the ESC/ERS Guidelines
Who cannot join
- That according to investigator criteria cannot participate in the trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Repeatability of Optical Coherence Tomography (OCT) and Intravascular Ultrasound (IV-US) in Pulmonary Arterial Hypertension
To assess the correlation between pulmonary IV-OCT and pulmonary IV-US measurements and standard PAH clinical measures of disease progression and the relative sensitivity of the techniques to change.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- Patients with Pulmonary Arterial Hypertension
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients with Pulmonary Arterial HypertensionProcedure or surgery
2 repeated measurement session to enable assessment of technical and medium-term reproducibility of IV-US and IV-OCT.
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary Arterial Hypertension | Experimental | Patients with Pulmonary Arterial Hypertension Receives: Procedure: Patients with Pulmonary Arterial Hypertension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Image measurements
Repeat acquisitions to be made in the same regions and in locations
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2017
- Study startApr 2016
- Primary completion18 Oct 2017
- Study completion25 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Enric Domingo, MD, Principal investigator, Hospital Vall d'Hebron
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03105934
- Sponsor's protocol ID
- IVUS
- Status last verified
- Feb 2018
- First submitted
- 4 Apr 2017
- Last updated
- 12 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repeatability of Optical Coherence Tomography (OCT) and Intravascular Ultrasound (IV-US) in Pulmonary Arterial Hypertension
- ClinicalTrials.gov ID
- NCT03105934
- Acronym / sponsor ID
- IVUS
- Conditions
- Pulmonary Arterial Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- 18 Oct 2017 (actual)
- Study completion
- 25 Jan 2018 (actual)
- First posted
- 10 Apr 2017 (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 assess the correlation between pulmonary IV-OCT and pulmonary IV-US measurements and standard PAH clinical measures of disease progression and the relative sensitivity of the techniques to change.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pulmonary Arterial Hypertension | Experimental | Procedure: Patients with Pulmonary Arterial HypertensionPatients with Pulmonary Arterial Hypertension |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- With confirmed diagnosis of PAH Group 1 according to the ESC/ERS Guidelines
- With severe disease, defined as Class II- III of the modified WHO functional classes in the ESC/ERS Guidelines
Key exclusion criteria (1 listed)
- That according to investigator criteria cannot participate in the trial
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 |
|---|---|---|
| Patients with Pulmonary Arterial Hypertension2 repeated measurement session to enable assessment of technical and medium-term reproducibility of IV-US and IV-OCT. | Procedure or surgery | Pulmonary Arterial Hypertension |
Primary outcome
Image measurements
Time frame: 12 months
Repeat acquisitions to be made in the same regions and in locations
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 12 Feb 2018.
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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.
Enric Domingo, MD principal investigator
Hospital Vall d'Hebron
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patients with Pulmonary Arterial Hypertension in people with Pulmonary Arterial Hypertension, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
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 12 Feb 2018. 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 Spain. 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?
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?
Image measurements (time frame: 12 months). 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 12 Feb 2018.