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

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

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

Study Overview

• Status: Unknown
• Conditions: Chronic Thromboembolic Pulmonary Hypertension
• Intervention / Treatment: 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
• Enrollment (Anticipated): 40

Contacts and Locations

Study Locations

• Russian Federation
  • Novosibirskaya Oblast'
    • Novosibirsk, Novosibirskaya Oblast', Russian Federation, 630055
      • Recruiting
      • Novosibirsk Research Institute of Circulation Pathology
      • Contact: Alexander Edemskiy, MD; Phone Number: +79139160665; Email: aeskander@yandex.ru

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Novosibirsk Scientific Research Institute for Circulatory Pathology

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): November 10, 2017
• Study Completion (Anticipated): March 10, 2018

Study Registration Dates

• First Submitted: November 12, 2017
• First Submitted That Met QC Criteria: November 18, 2017
• First Posted (Actual): November 21, 2017

Study Record Updates

• Last Update Posted (Actual): November 21, 2017
• Last Update Submitted That Met QC Criteria: November 18, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Hypertension, Pulmonary
• Other Study ID Numbers: NCTEPHR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No