Pulmonary Arterial HypertensionNCT05417373
Algorithms to Diagnose Pulmonary Arterial Hypertension
An observational study of Pulmonary Arterial Hypertension, run by RenJi Hospital at 1 site in China.
Trial summary
The investigators intend to evalute the value of radiomics signature of pulmonary vessels from chest computed tomography (CT) for dianosis and prognosis of pulmonary arterial hypertension. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- calculated radscore
- How many people
- 250 participants
- Where
- 1 siteChina
- Study dates
- 17 Jan 2019to 1 Jun 2023
- How long will I take part?
- 2 Years
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The development cohort is case_control research, composed of patients diagnosed with PAH and healthy control group from 2018.10 to now in RenjiH and Jiangsu Province Hospital. The validation cohort is prospective study to test the accuracy of diagonisis model, composed of patients are suspected as PAH or healthy volunteer by echocardiography form other medical institutions.
Who may be able to join
- Chest CT examination and cardiac ultrasound examination were performed within 3 months before and after right heart catheterization;
- mPAP > 25mmHg and PVR< 3woods (measured by right heart catheter) and pulmonary vascular resistance was collected as PAH group whereas Healthy Volunteers as non-PAH control group in developement corhort;
- sPAP > 36mmHg (measured by echocardiography) was collected in validation corhort.
Who cannot join
- 1.Cancer; 2. The quality of chest CT and cardiac ultrasound images is poor; 3.Pulmonary vascular segmentation is affected by thoracic organ displacement or pulmonary vascular complete occlusion due to diseases ,such as spinal deformity.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Renji Hospital
Shanghai, 200127
Binaqian Ruan, postgraduate, +8613616692589, 907945323@qq.com
About this study
Official title: Development and Validation of a Radiomics-based Diagnosis Model for Pulmonary Arterial Hypertension
The investigators intend to evalute the value of radiomics signature of pulmonary vessels from chest computed tomography (CT) for dianosis and prognosis of pulmonary arterial hypertension.
Read the detailed description
Pulmonary arterial hypertension (PAH) is a heterogeneous disorder composed of varying pathobiology that may involve multiple clinical conditions. Computed tomography (CT) is a minimally invasive imaging technique capable of providing both high contrast and high resolution detail of the lungs and arteries. Application of radiomics as prognosis and diagnosis tools could quantifies high-dimensional features from CT data to investigate vescualr heterogeneity.Development and validation of PAH diagnosis Algorithms based on radiomics may serve as a complementary readout to current CT-based metrics and provide valuable evidence to make the treatment management decision in early PAH.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- calculated radscore
- Keywords
- Pulmonary Arterial Hypertension, Diagnosis Model, Prediction Algorithm
- 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.
calculated radscoreOther
The development cohort is case_control research. The validation cohort is prospective study to test the accuracy of calculated radscore based on diagonisis model.
| Study group | Role | What they receive |
|---|---|---|
| The development cohort | The development cohort was composed of patients diagnosed with PAH and healthy control group from 2019.1-2021.5 in RenjiH. | |
| The validation cohort | The validation cohort was composed of patients are suspected as PAH by echocardiography in 2021.5-2021.12 or suspected patients are form other medical institutions. Receives: Other: calculated radscore |
What is being measured
The primary outcome is the main question the study is designed to answer.
DIAGONOSIS
The patient is diagnosed PAH or not by right heart catheter
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start17 Jan 2019
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Jun 2023 (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 Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe 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
- Other
- Time perspective
- Other
- Enrolment
- 250 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Zhongshan Hospital, The First Affiliated Hospital with Nanjing Medical University, Xinqiao Hospital of Chongqing, Shanghai Pulmonary Hospital, Shanghai, China
- Responsible party
- Sponsor
- Investigators
- Jieyan Shen, PhD, Study chair, Shanghai Jiao Tong University School of Medicine Affiliated Renji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05417373
- Sponsor's protocol ID
- diagnosis of PAH
- Status last verified
- Mar 2022
- First submitted
- 6 Jun 2022
- Last updated
- 14 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wan C, Chen M, Tong J, Wang A, Ruan B, Shen J. Prognostic effect of left ventricular-pulmonary arterial coupling indicator in pulmonary arterial hypertension. Int J Cardiol. 2025 Sep 1;434:133347. doi: 10.1016/j.ijcard.2025.133347. Epub 2025 May 1.
PubMed 40318737
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Radiomics-based Diagnosis Model for Pulmonary Arterial Hypertension
- ClinicalTrials.gov ID
- NCT05417373
- Acronym / sponsor ID
- diagnosis of PAH
- Conditions
- Pulmonary Arterial Hypertension
- Keywords
- Pulmonary Arterial Hypertension, Diagnosis Model, Prediction Algorithm
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Collaborators
- Shanghai Zhongshan Hospital, The First Affiliated Hospital with Nanjing Medical University, Xinqiao Hospital of Chongqing, Shanghai Pulmonary Hospital, Shanghai, China
- Study start
- 17 Jan 2019 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 14 Jun 2022 (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 investigators intend to evalute the value of radiomics signature of pulmonary vessels from chest computed tomography (CT) for dianosis and prognosis of pulmonary arterial hypertension.
Detailed description
Pulmonary arterial hypertension (PAH) is a heterogeneous disorder composed of varying pathobiology that may involve multiple clinical conditions. Computed tomography (CT) is a minimally invasive imaging technique capable of providing both high contrast and high resolution detail of the lungs and arteries. Application of radiomics as prognosis and diagnosis tools could quantifies high-dimensional features from CT data to investigate vescualr heterogeneity.Development and validation of PAH diagnosis Algorithms based on radiomics may serve as a complementary readout to current CT-based metrics and provide valuable evidence to make the treatment management decision in early PAH.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The development cohort | – | –The development cohort was composed of patients diagnosed with PAH and healthy control group from 2019.1-2021.5 in RenjiH. |
| The validation cohort | – | Other: calculated radscoreThe validation cohort was composed of patients are suspected as PAH by echocardiography in 2021.5-2021.12 or suspected patients are form other medical institutions. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The development cohort is case_control research, composed of patients diagnosed with PAH and healthy control group from 2018.10 to now in RenjiH and Jiangsu Province Hospital. The validation cohort is prospective study to test the accuracy of diagonisis model, composed of patients are suspected as PAH or healthy volunteer by echocardiography form other medical institutions.
Key inclusion criteria (3 listed)
- Chest CT examination and cardiac ultrasound examination were performed within 3 months before and after right heart catheterization;
- mPAP > 25mmHg and PVR< 3woods (measured by right heart catheter) and pulmonary vascular resistance was collected as PAH group whereas Healthy Volunteers as non-PAH control group in developement corhort;
- sPAP > 36mmHg (measured by echocardiography) was collected in validation corhort.
Key exclusion criteria (1 listed)
- 1.Cancer; 2. The quality of chest CT and cardiac ultrasound images is poor; 3.Pulmonary vascular segmentation is affected by thoracic organ displacement or pulmonary vascular complete occlusion due to diseases ,such as spinal deformity.
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 |
|---|---|---|
| calculated radscoreThe development cohort is case_control research. The validation cohort is prospective study to test the accuracy of calculated radscore based on diagonisis model. | Other | The validation cohort |
Primary outcome
DIAGONOSIS
Time frame: 1 year
The patient is diagnosed PAH or not by right heart catheter
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2022.
- Derived from this study: PubMed 40318737Wan C, Chen M, Tong J, Wang A, Ruan B, Shen J. Prognostic effect of left ventricular-pulmonary arterial coupling indicator in pulmonary arterial hypertension. Int J Cardiol. 2025 Sep 1;434:133347. doi: 10.1016/j.ijcard.2025.133347. Epub 2025 May 1.
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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.
Jieyan Shen, PhD study chair
Shanghai Jiao Tong University School of Medicine Affiliated Renji Hospital
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 Pulmonary Arterial Hypertension, run by RenJi Hospital at 1 site in China.
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 3 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 14 Jun 2022. 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 China. 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 Jieyan Shen, PhD (13701864819, shenjieyan@renji.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DIAGONOSIS (time frame: 1 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 NCT05417373, 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 14 Jun 2022.