CClinicalTrials.gg
Sign In
Status unknownNCT03349164NCTEPHRUpdated Nov 21, 2017

Registry of Patients With Chronic Thromboembolic Pulmonary Hypertension in Novosibirsk Region

An observational study in Chronic Thromboembolic Pulmonary Hypertension, sponsored by Novosibirsk Scientific Research Institute for Circulatory Pathology. Status unknown at 1 site in Russian Federation. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-11-21.

Sponsored by Novosibirsk Scientific Research Institute for Circulatory Pathology · Observational

The sponsor has not verified this record recently (last verified Nov 2017), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Other
Enrollment
40
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Chronic Thromboembolic Pulmonary Hypertension
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Inclusion criteria

  • patients who had episodes of acute pulmonary embolism
  • 3-4 months of anticoagulation treatment after acute pulmonary embolism
  • informed consent

Exclusion criteria

Exclusion Criteria:

  • pregnancy
04

Study design

Observational model
Other
Time perspective
Other
Enrollment
40 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testacute PE survivors

    Patients from this group will be assessed by cardiologist, echocardiography and VQ scanning

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: 3-4 month after acute pulmonary embolism

  2. clinical presentation of chronic thromboembolic pulmonary hypertension

    clinical assessment of physical capacity of patient with 6 minute walking distance test and NYHA functional class

    Time frame: 3-4 month after acute pulmonary embolism

Secondary outcomes

  1. 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

    Time frame: 3-4 month after acute pulmonary embolism

  2. presence of perfusion deficit in pulmonary artery according to VQ scan

    presence of perfusion deficit in pulmonary artery according to VQ scan

    Time frame: 3-4 month after acute pulmonary embolism

06

Study locations

1 of 1 sites recruiting
  • Novosibirsk research institute of circulation pathology
    Novosibirsk, Novosibirskaya Oblast' 630055, Russian Federation
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03349164
Lead sponsor
Novosibirsk Scientific Research Institute for Circulatory Pathology
Responsible party
Sponsor
First posted
Nov 21, 2017
Start date
Jan 1, 2017
Primary completion
Nov 10, 2017
Completion
Mar 10, 2018 (estimated)
Last update
Nov 21, 2017

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Hypertension, Pulmonary→

Other studies from this sponsor

Novosibirsk Scientific Research Institute for Circulatory Pathology

Start the discussion