Chronic Thromboembolic Pulmonary HypertensionCTEPH-SOLUTIONNCT04681014
CTEPH in Patients With Prior Pulmonary Embolism and Risk Score Validation
An observational study of Chronic Thromboembolic Pulmonary Hypertension and Pulmonary Embolism, run by iPHNET (italian Pulmonary Hypertension NETwork) at 1 site in Italy.
Trial summary
CTEPH-SOLUTION aims to create a risk score for the early detection of Chronic Thrombo-Embolic Pulmonary Hypertension (CTEPH) among patients with previous pulmonary embolism. The risk score, created on retrospective data, will be validated on newly diagnosed pulmonary embolism patients. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chronic Thromboembolic Pulmonary Hypertension, Pulmonary Embolism
- How many people
- 1,218 participants
- Where
- 1 siteItaly
- Study dates
- 21 Jan 2016to 31 Jul 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with prior pulmonary embolism followed by centres for anticoagulant therapy management (TAO centres) will be enrolled by the investigator's centres and undergo baseline evaluation for prevalent CTEPH detection; al CTEPH will be confirmed by right heart catheterization.
Who may be able to join
- Age ≥ 18 at baseline evaluation
- Diagnosis of prior (> 30 days from pulmonary embolism onset) or new-onset pulmonary embolism, according to the ESC guidelines on the diagnosis and management of acute pulmonary embolism
Who cannot join
- patients without pulmonary embolism diagnosis
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of Clinical, Internal, Anesthesiological and Cardiovascular Sciences. AOU Policlinico Umberto I
Rome, 00161
About this study
Official title: Evidence-based Detection of CTEPH in Patients With Prior Pulmonary Embolism: Risk Score Evaluation and Validation.
CTEPH-SOLUTION aims to create a risk score for the early detection of Chronic Thrombo-Embolic Pulmonary Hypertension (CTEPH) among patients with previous pulmonary embolism.
The risk score, created on retrospective data, will be validated on newly diagnosed pulmonary embolism patients.
Read the detailed description
CTEPH-SOLUTION is a multicenter observational cross-sectional and prospective study in patients with a prior and new diagnosis of pulmonary embolism.
Patients with prior pulmonary embolism will be screened at baseline with doppler echocardiography: an estimated sPAP ≥ 40 mmHg will be the indication for pulmonary hypertension detection. After 24 months from baseline, patients will be followed-up for CTEPH detection. CTEPH diagnosis will be carried out according to the current ESC/ERS guidelines.
Incident (pulmonary embolism episode at least three months before the baseline) and prevalent (pulmonary embolism episode) patients will be enrolled.
- Medical subject headings
- Pulmonary Embolism
What is being measured
The primary outcome is the main question the study is designed to answer.
CTEPH-SOLUTION score
The CTEPH-SOLUTION score will be created on retrospective parameters (i.e., demographic data, diagnostic and clinical information, risk factors, laboratories parameters) collected on pulmonary embolism patients.
The minimum and maximum values will be defined after the multivariate statistical analysis, and the risk factors analyzed a posteriori. Higher scores mean a worse outcome.
Measured: 24 months
Secondary outcomes (1)
The number of the subject with a diagnosis of CTEPH on the total number of subjects enrolled.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study start21 Jan 2016
- Primary completion31 Jul 2020
- Study completion31 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Thromboembolic Pulmonary HypertensionStudies 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 crossover
- Time perspective
- Cross-sectional
- Enrolment
- 1,218 participants (actual)
Sponsor and investigators
- Lead sponsor
- iPHNET (italian Pulmonary Hypertension NETwork)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04681014
- Sponsor's protocol ID
- CTEPH-SOLUTION
- Acronym
- CTEPH-SOLUTION
- Status last verified
- Dec 2020
- First submitted
- 17 Dec 2020
- Last updated
- 23 Dec 2020
- 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 23 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evidence-based Detection of CTEPH in Patients With Prior Pulmonary Embolism: Risk Score Evaluation and Validation.
- ClinicalTrials.gov ID
- NCT04681014
- Acronym / sponsor ID
- CTEPH-SOLUTION / CTEPH-SOLUTION
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,218 participants (actual)
- Lead sponsor
- iPHNET (italian Pulmonary Hypertension NETwork)University, hospital or other
- Study start
- 21 Jan 2016 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Jul 2022 (estimated)
- First posted
- 23 Dec 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.
CTEPH-SOLUTION aims to create a risk score for the early detection of Chronic Thrombo-Embolic Pulmonary Hypertension (CTEPH) among patients with previous pulmonary embolism.
The risk score, created on retrospective data, will be validated on newly diagnosed pulmonary embolism patients.
Detailed description
CTEPH-SOLUTION is a multicenter observational cross-sectional and prospective study in patients with a prior and new diagnosis of pulmonary embolism.
Patients with prior pulmonary embolism will be screened at baseline with doppler echocardiography: an estimated sPAP ≥ 40 mmHg will be the indication for pulmonary hypertension detection. After 24 months from baseline, patients will be followed-up for CTEPH detection. CTEPH diagnosis will be carried out according to the current ESC/ERS guidelines.
Incident (pulmonary embolism episode at least three months before the baseline) and prevalent (pulmonary embolism episode) patients will be enrolled.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with prior pulmonary embolism followed by centres for anticoagulant therapy management (TAO centres) will be enrolled by the investigator's centres and undergo baseline evaluation for prevalent CTEPH detection; al CTEPH will be confirmed by right heart catheterization.
Key inclusion criteria (2 listed)
- Age ≥ 18 at baseline evaluation
- Diagnosis of prior (> 30 days from pulmonary embolism onset) or new-onset pulmonary embolism, according to the ESC guidelines on the diagnosis and management of acute pulmonary embolism
Key exclusion criteria (1 listed)
- patients without pulmonary embolism diagnosis
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
CTEPH-SOLUTION score
Time frame: 24 months
The CTEPH-SOLUTION score will be created on retrospective parameters (i.e., demographic data, diagnostic and clinical information, risk factors, laboratories parameters) collected on pulmonary embolism patients. The minimum and maximum values will be defined after the multivariate statistical analysis, and the risk factors analyzed a posteriori. Higher scores mean a worse outcome.
1 secondary outcome
The number of the subject with a diagnosis of CTEPH on the total number of subjects enrolled.
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Chronic Thromboembolic Pulmonary Hypertension and Pulmonary Embolism, run by iPHNET (italian Pulmonary Hypertension NETwork) 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 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: status not confirmed, as of the sponsor's last update on 23 Dec 2020. 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?
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?
CTEPH-SOLUTION score (time frame: 24 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 23 Dec 2020.