NCT03349164

Brief Summary

There will be assessment of patients after acute pulmonary embolism for the development of CTEPH

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2017

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

November 12, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 21, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2018

Completed
Last Updated

November 21, 2017

Status Verified

November 1, 2017

Enrollment Period

10 months

First QC Date

November 12, 2017

Last Update Submit

November 18, 2017

Conditions

Chronic Thromboembolic Pulmonary Hypertension

Outcome Measures

Primary Outcomes (2)

  • 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

    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

    3-4 month after acute pulmonary embolism

Secondary Outcomes (2)

  • presence of pulmonary hypertension - mean pulmonary artery pressure > 25 mm Hg according to echocardiography

    3-4 month after acute pulmonary embolism

  • presence of perfusion deficit in pulmonary artery according to VQ scan

    3-4 month after acute pulmonary embolism

Interventions

acute PE survivorsDIAGNOSTIC_TEST

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

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novosibirsk research institute of circulation pathology

Novosibirsk, Novosibirsk Oblast, 630055, Russia

RECRUITING

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2017

First Posted

November 21, 2017

Study Start

January 1, 2017

Primary Completion

November 10, 2017

Study Completion

March 10, 2018

Last Updated

November 21, 2017

Record last verified: 2017-11

Locations

RU(1)