NCT04773028

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 26, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 4, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 4, 2021

Completed
3 months until next milestone

Results Posted

Study results publicly available

August 10, 2021

Completed
Last Updated

August 10, 2021

Status Verified

August 1, 2021

Enrollment Period

10 months

First QC Date

February 19, 2021

Results QC Date

May 4, 2021

Last Update Submit

August 9, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Concentration of Matrix Metalloproteinase 2 and 9 Enzymes

    Measurement the concentration of matrix metalloproteinase 2 and 9 enzymes by elisa and western blot techniques.

    1 year

Study Arms (2)

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.

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.

Other: matrix metalloproteinase enzymes 2 and 9

Interventions

concentration of matrix metalloproteinase 2 and 9 enzymes

CONTROL GROUP(GROUP 2)PATİENT GROUP(GROUP 1)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Study population has chronic thromboembolic pulmonary hypertension and will be performed pulmonary thromboendarterectomy.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kartal Kosuyolu High Speciality Training and Research Hospital

Istanbul, Eyalet/Yerleşke, 34800, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Samples was teken from pulmonary endarterectomy material during the operation. This material is removed routinly this surgical procedure. At this studt any extra surgical procedure did not performed to participans.

Results Point of Contact

Title
Dr.Ahmet Zengin
Organization
Kartal Kosuyolu Hihg Speciality Training and Research Hospital

Study Officials

  • mehmet yanartas

    kartal kosuyolu hıgh specıalty training and research hospital

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
medical doctor

Study Record Dates

First Submitted

February 19, 2021

First Posted

February 26, 2021

Study Start

July 1, 2020

Primary Completion

May 4, 2021

Study Completion

May 4, 2021

Last Updated

August 10, 2021

Results First Posted

August 10, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

The data used in the study will be kept closed to the use of other users.

Locations