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NCT03349164 Clinical Trial

Registry of Patients With Chronic Thromboembolic Pulmonary Hypertension in Novosibirsk Region

Chronic Thromboembolic Pulmonary Hypertension Clinical Trial

— NCTEPHR  

Official title:
Local Registry of Patients With Chronic Thromboembolic Pulmonary Hypertension in Novosibirsk Region

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03349164
Other study ID # NCTEPHR
Secondary ID
Status Recruiting
Phase N/A
First received November 12, 2017
Last updated November 18, 2017
Start date January 1, 2017
Est. completion date March 10, 2018

Study information
Verified date November 2017
Source Novosibirsk Scientific Research Institute for Circulatory Pathology
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date March 10, 2018
Est. primary completion date November 10, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Russian Federation Novosibirsk research institute of circulation pathology Novosibirsk Novosibirskaya Oblast'

Sponsors (1)
Lead Sponsor Collaborator
Novosibirsk Scientific Research Institute for Circulatory Pathology

Country where clinical trial is conducted

Russian Federation, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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 3-4 month after acute pulmonary embolism
Secondary presence of perfusion deficit in pulmonary artery according to VQ scan presence of perfusion deficit in pulmonary artery according to VQ scan 3-4 month after acute pulmonary embolism
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