Chronic Thromboembolic Pulmonary HypertensionNCTEPHRNCT03349164
Registry of Patients With Chronic Thromboembolic Pulmonary Hypertension in Novosibirsk Region
An observational study of Chronic Thromboembolic Pulmonary Hypertension, run by Novosibirsk Scientific Research Institute for Circulatory Pathology at 1 site in Russia.
Trial summary
There will be assessment of patients after acute pulmonary embolism for the development of CTEPH Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Thromboembolic Pulmonary Hypertension
- What is being tested?
- acute PE survivors
- How many people
- 40 participants
- Where
- 1 siteRussia
- Study dates
- 1 Jan 2017to 10 Mar 2018
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients are survivors after acute PE. Than they should intake anticoagulation treatment at least 3-4 month. Then they will be assessed clinically by local cardiologists, echocardiography and VQ scan will be performed.
Who may be able to join
- patients who had episodes of acute pulmonary embolism
- 3-4 months of anticoagulation treatment after acute pulmonary embolism
- informed consent
Who cannot join
- pregnancy
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Novosibirsk research institute of circulation pathology
Novosibirsk, Novosibirsk Oblast, 630055
Alexander Edemskiy, MD, +79139160665, aeskander@yandex.ru
About this study
Official title: Local Registry of Patients With Chronic Thromboembolic Pulmonary Hypertension in Novosibirsk Region
There will be assessment of patients after acute pulmonary embolism for the development of CTEPH
Read the detailed description
There will be assessment of patients after acute pulmonary embolism for the development of CTEPH.
There will be analysis of case histories of 40 patients with acute pulmonary embolism. All this patients will be clinically assessed by local cardiologist. Also echocardiography, lung VQ scans (perfusion and ventilation) will be performed.
Patients with chronic thromboembolic pulmonary hypertension will be assessed by local team experienced in CTEPH treatment.
- Being tested
- acute PE survivors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acute PE survivorsDiagnostic test
Patients from this group will be assessed by cardiologist, echocardiography and VQ scanning
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical presentation of chronic thromboembolic pulmonary hypertension
presence of dyspnea after acute pulmonary embolism will be the sign of clinical symptomatic patients. Dyspnea will be assessed with Borg scale
Measured: 3-4 month after acute pulmonary embolism
clinical presentation of chronic thromboembolic pulmonary hypertension
clinical assessment of physical capacity of patient with 6 minute walking distance test and NYHA functional class
Measured: 3-4 month after acute pulmonary embolism
Secondary outcomes (2)
presence of pulmonary hypertension - mean pulmonary artery pressure > 25 mm Hg according to echocardiography
presence of pulmonary hypertension - mean pulmonary artery pressure > 25 mm Hg according to echocardiography
Measured: 3-4 month after acute pulmonary embolism
presence of perfusion deficit in pulmonary artery according to VQ scan
presence of perfusion deficit in pulmonary artery according to VQ scan
Measured: 3-4 month after acute pulmonary embolism
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2017
- Study start1 Jan 2017
- Primary completion10 Nov 2017
- Study completion10 Mar 2018 (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
- Other
- Time perspective
- Other
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novosibirsk Scientific Research Institute for Circulatory Pathology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03349164
- Sponsor's protocol ID
- NCTEPHR
- Acronym
- NCTEPHR
- Status last verified
- Nov 2017
- First submitted
- 12 Nov 2017
- Last updated
- 21 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Registry of Patients With Chronic Thromboembolic Pulmonary Hypertension in Novosibirsk Region
- ClinicalTrials.gov ID
- NCT03349164
- Acronym / sponsor ID
- NCTEPHR / NCTEPHR
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Novosibirsk Scientific Research Institute for Circulatory PathologyUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 10 Nov 2017 (actual)
- Study completion
- 10 Mar 2018 (estimated)
- First posted
- 21 Nov 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.
There will be assessment of patients after acute pulmonary embolism for the development of CTEPH
Detailed description
There will be assessment of patients after acute pulmonary embolism for the development of CTEPH.
There will be analysis of case histories of 40 patients with acute pulmonary embolism. All this patients will be clinically assessed by local cardiologist. Also echocardiography, lung VQ scans (perfusion and ventilation) will be performed.
Patients with chronic thromboembolic pulmonary hypertension will be assessed by local team experienced in CTEPH treatment.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients are survivors after acute PE. Than they should intake anticoagulation treatment at least 3-4 month. Then they will be assessed clinically by local cardiologists, echocardiography and VQ scan will be performed.
Key inclusion criteria (3 listed)
- patients who had episodes of acute pulmonary embolism
- 3-4 months of anticoagulation treatment after acute pulmonary embolism
- informed consent
Key exclusion criteria (1 listed)
- pregnancy
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 |
|---|---|---|
| acute PE survivorsPatients from this group will be assessed by cardiologist, echocardiography and VQ scanning | Diagnostic test | – |
Primary outcome
clinical presentation of chronic thromboembolic pulmonary hypertension
Time frame: 3-4 month after acute pulmonary embolism
presence of dyspnea after acute pulmonary embolism will be the sign of clinical symptomatic patients. Dyspnea will be assessed with Borg scale
clinical presentation of chronic thromboembolic pulmonary hypertension
Time frame: 3-4 month after acute pulmonary embolism
clinical assessment of physical capacity of patient with 6 minute walking distance test and NYHA functional class
2 secondary outcomes
presence of pulmonary hypertension - mean pulmonary artery pressure > 25 mm Hg according to echocardiography
Time frame: 3-4 month after acute pulmonary embolism
presence of perfusion deficit in pulmonary artery according to VQ scan
Time frame: 3-4 month after acute pulmonary embolism
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2017.
- Individual participant dataSharing planned: Undecided
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The Effect of Levosimendan on Pulmonary Artery Pressure and Right Ventricular Function in the Perioperative Period in Patients With CTEPH After Pulmonary Thromboendarterectomy
LEVOSIMENDAN, PULMONARY THROMBOENDARTERECTOMY
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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.
Novosibirsk research institute of circulation pathology
Novosibirsk, Russia
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, run by Novosibirsk Scientific Research Institute for Circulatory Pathology at 1 site in Russia.
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 21 Nov 2017. 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 Russia. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical presentation of chronic thromboembolic pulmonary hypertension (time frame: 3-4 month after acute pulmonary embolism). The study lists 2 primary outcomes in all. 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 21 Nov 2017.