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Trial record 12 of 33 for:    CTEPH | Recruiting, Not yet recruiting, Available Studies

Registry of Patients With Chronic Thromboembolic Pulmonary Hypertension in Novosibirsk Region (NCTEPHR)

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ClinicalTrials.gov Identifier: NCT03349164
Recruitment Status : Recruiting
First Posted : November 21, 2017
Last Update Posted : November 21, 2017
Sponsor:
Information provided by (Responsible Party):
Novosibirsk Scientific Research Institute for Circulatory Pathology

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

Condition or disease Intervention/treatment
Chronic Thromboembolic Pulmonary Hypertension Diagnostic Test: acute PE survivors

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 Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Other
Time Perspective: Other
Official Title: Local Registry of Patients With Chronic Thromboembolic Pulmonary Hypertension in Novosibirsk Region
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : November 10, 2017
Estimated Study Completion Date : March 10, 2018



Intervention Details:
  • Diagnostic Test: acute PE survivors
    Patients from this group will be assessed by cardiologist, echocardiography and VQ scanning


Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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 pulmonary hypertension - mean pulmonary artery pressure > 25 mm Hg according to echocardiography

  2. presence of perfusion deficit in pulmonary artery according to VQ scan [ Time Frame: 3-4 month after acute pulmonary embolism ]
    presence of perfusion deficit in pulmonary artery according to VQ scan



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03349164


Locations
Russian Federation
Novosibirsk research institute of circulation pathology Recruiting
Novosibirsk, Novosibirskaya Oblast', Russian Federation, 630055
Contact: Alexander Edemskiy, MD    +79139160665    aeskander@yandex.ru   
Sponsors and Collaborators
Novosibirsk Scientific Research Institute for Circulatory Pathology

Responsible Party: Novosibirsk Scientific Research Institute for Circulatory Pathology
ClinicalTrials.gov Identifier: NCT03349164     History of Changes
Other Study ID Numbers: NCTEPHR
First Posted: November 21, 2017    Key Record Dates
Last Update Posted: November 21, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases