Chronic Thromboembolic Pulmonary HypertensionNCT04773028
The Role of Matrix Metalloproteinase 2 and 9 Enzymes in Developing Chronic Thromboembolic Pulmonary Hypertension
An observational study of Chronic Thromboembolic Pulmonary Hypertension, run by AHMET ZENGIN at 1 site in Turkey (Türkiye).
Trial summary
Chronic thromboembolic pulmonary hypertension is an occlusive disease in pulmonary artery.Matrix metalloproteinase enzymes play a substantial role of extracellular matrix remodeling. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Thromboembolic Pulmonary Hypertension
- What is being tested?
- matrix metalloproteinase enzymes 2 and 9
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2020to 4 May 2021
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study population has chronic thromboembolic pulmonary hypertension and will be performed pulmonary thromboendarterectomy.
Who may be able to join
- Despite 3 months of anticoagulation therapy
- mean pulmonary arterial pressure > 20 mmHg
- pulmonary vasculary resistance > 3 wood
- pulmonary capillary wedge pressure < 15 mmHg
- perfusion defect in ventilation perfusion scintigraphy
- pulmonary angiography or computed tomography angiography showing pulmonary artery occlusive lesions
Who cannot join
- Patients undergoing pulmonary thromboendarterectomy concomitant coronary bypass, carotid endarterectomy, aortic valve, ascending aorta, mitral valve, tricuspid valve, pulmonary valve surgery
- Patients who have undergone surgical or percutaneous procedures due to atherosclerotic disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kartal Kosuyolu High Speciality Training and Research Hospital
Istanbul, Eyalet/Yerleşke, 34800
About this study
Chronic thromboembolic pulmonary hypertension is an occlusive disease in pulmonary artery.Matrix metalloproteinase enzymes play a substantial role of extracellular matrix remodeling. The clot formed in chronic thromboembolic pulmonary hypertension does not melt and turns into a fibrous state, it occludes the pulmonary artery.In this study, investigators aimed to investigate the role of matrix metalloproteinase enzymes in pulmonary arterial wall remodeling in patients with chronic thromboembolic pulmonary hypertension
Read the detailed description
Chronic thromboembolic pulmonary hypertension is an occlusive disease in pulmonary artery. Only 4% of patients with acute pulmonary embolism develop chronic thromboembolic pulmonary hypertension and acute pulmonary embolism or deep vein thrombosis is reported in the anamnesis of 75% of those with chronic thromboembolic disease. Therefore, the etiology of the disease is not clear. Altought many studies are done, especially the role of inflamation is emhasised underlie the disease.
Matrix metalloproteinase enzymes play a substantial role of extracellular matrix remodeling. The clot formed in chronic thromboembolic pulmonary hypertension does not melt and turns into a fibrous state, it occludes the pulmonary artery.In this study, investigators aimed to investigate the role of matrix metalloproteinase enzymes in pulmonary arterial wall remodeling in patients with chronic thromboembolic pulmonary hypertension.
Matrix metalloprotinase enzymes are known to play a role in atherosclerosis. This research will investigate whether there is atherosclerosis together with inflamattion in the background of chronic thromboembolic hypertension.
- Being tested
- matrix metalloproteinase enzymes 2 and 9
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
matrix metalloproteinase enzymes 2 and 9Other
concentration of matrix metalloproteinase 2 and 9 enzymes
| Study group | Role | What they receive |
|---|---|---|
| PATİENT GROUP(GROUP 1) | This group is the group that underwent pulmonary thromboendarterectomy due to chronic thromboembolic pulmonary hypertension.Sample was taken from the material extracted from this group during operation. Receives: Other: matrix metalloproteinase enzymes 2 and 9 | |
| CONTROL GROUP(GROUP 2) | This group is the group that underwent lobectomy or pneumonectomy for another reason that the pulmonary artery is not affected. Patients operated for a reason other than chronic thromboembolic pulmonary hypertension and samples were taken from the intact pulmonary artery of the removed lung. Receives: Other: matrix metalloproteinase enzymes 2 and 9 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of Matrix Metalloproteinase 2 and 9 Enzymes
Measurement the concentration of matrix metalloproteinase 2 and 9 enzymes by elisa and western blot techniques.
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 posted26 Feb 2021
- Study start1 Jul 2020
- Primary completion4 May 2021
- Study completion4 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- AHMET ZENGIN
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, AHMET ZENGIN, Kartal Kosuyolu High Speciality Training and Research Hospital
- Investigators
- mehmet yanartas, Study director, kartal kosuyolu hıgh specıalty training and research hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04773028
- Sponsor's protocol ID
- 2020-071
- Status last verified
- Aug 2021
- First submitted
- 19 Feb 2021
- Last updated
- 10 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data used in the study will be kept closed to the use of other users.
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Matrix Metalloproteinase 2 and 9 Enzymes in Developing Chronic Thromboembolic Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT04773028
- Acronym / sponsor ID
- 2020-071
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- AHMET ZENGINOther government
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 4 May 2021 (actual)
- Study completion
- 4 May 2021 (actual)
- First posted
- 26 Feb 2021 (actual)
- Results
- Posted 10 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic thromboembolic pulmonary hypertension is an occlusive disease in pulmonary artery.Matrix metalloproteinase enzymes play a substantial role of extracellular matrix remodeling. The clot formed in chronic thromboembolic pulmonary hypertension does not melt and turns into a fibrous state, it occludes the pulmonary artery.In this study, investigators aimed to investigate the role of matrix metalloproteinase enzymes in pulmonary arterial wall remodeling in patients with chronic thromboembolic pulmonary hypertension
Detailed description
Chronic thromboembolic pulmonary hypertension is an occlusive disease in pulmonary artery. Only 4% of patients with acute pulmonary embolism develop chronic thromboembolic pulmonary hypertension and acute pulmonary embolism or deep vein thrombosis is reported in the anamnesis of 75% of those with chronic thromboembolic disease. Therefore, the etiology of the disease is not clear. Altought many studies are done, especially the role of inflamation is emhasised underlie the disease.
Matrix metalloproteinase enzymes play a substantial role of extracellular matrix remodeling. The clot formed in chronic thromboembolic pulmonary hypertension does not melt and turns into a fibrous state, it occludes the pulmonary artery.In this study, investigators aimed to investigate the role of matrix metalloproteinase enzymes in pulmonary arterial wall remodeling in patients with chronic thromboembolic pulmonary hypertension.
Matrix metalloprotinase enzymes are known to play a role in atherosclerosis. This research will investigate whether there is atherosclerosis together with inflamattion in the background of chronic thromboembolic hypertension.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PATİENT GROUP(GROUP 1) | – | Other: matrix metalloproteinase enzymes 2 and 9This group is the group that underwent pulmonary thromboendarterectomy due to chronic thromboembolic pulmonary hypertension.Sample was taken from the material extracted from this group during operation. |
| CONTROL GROUP(GROUP 2) | – | Other: matrix metalloproteinase enzymes 2 and 9This group is the group that underwent lobectomy or pneumonectomy for another reason that the pulmonary artery is not affected. Patients operated for a reason other than chronic thromboembolic pulmonary hypertension and samples were taken from the intact pulmonary artery of the removed lung. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population has chronic thromboembolic pulmonary hypertension and will be performed pulmonary thromboendarterectomy.
Key inclusion criteria (6 listed)
- Despite 3 months of anticoagulation therapy
- mean pulmonary arterial pressure > 20 mmHg
- pulmonary vasculary resistance > 3 wood
- pulmonary capillary wedge pressure < 15 mmHg
- perfusion defect in ventilation perfusion scintigraphy
Key exclusion criteria (2 listed)
- Patients undergoing pulmonary thromboendarterectomy concomitant coronary bypass, carotid endarterectomy, aortic valve, ascending aorta, mitral valve, tricuspid valve, pulmonary valve surgery
- Patients who have undergone surgical or percutaneous procedures due to atherosclerotic disease
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 |
|---|---|---|
| matrix metalloproteinase enzymes 2 and 9concentration of matrix metalloproteinase 2 and 9 enzymes | Other | CONTROL GROUP(GROUP 2), PATİENT GROUP(GROUP 1) |
Primary outcome
Concentration of Matrix Metalloproteinase 2 and 9 Enzymes
Time frame: 1 year
Measurement the concentration of matrix metalloproteinase 2 and 9 enzymes by elisa and western blot techniques.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. The data used in the study will be kept closed to the use of other users.
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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.
mehmet yanartas study director
kartal kosuyolu hıgh specıalty training and research 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 Chronic Thromboembolic Pulmonary Hypertension, run by AHMET ZENGIN at 1 site in Turkey (Türkiye).
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 6 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: finished, as of the sponsor's last update on 10 Aug 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 Turkey (Türkiye). 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?
Yes. Results are posted in the registry (first posted 10 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Concentration of Matrix Metalloproteinase 2 and 9 Enzymes (time frame: 1 year). 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 10 Aug 2021.