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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03579862
Other study ID # 1024723
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 25, 2013
Est. completion date December 31, 2023

Study information

Verified date October 2022
Source Intermountain Health Care, Inc.
Contact Valerie T Aston, MBA
Phone 801-507-4606
Email valerie.aston@imail.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Some patients who have blood clots come down with a life-threatening condition known as Chronic Thromboembolic Pulmonary Hypertension (CTEPH), which is high blood pressure only in the arteries of the lungs. This study seeks to understand more about the genetics causes of CTEPH by obtaining blood samples and examining family histories.


Description:

This project proposes to identify a cohort of Utah patients with CTEPH, and to perform a comprehensive analysis of family history and CTEPH risk factors in these patients, and in controls with acute pulmonary embolism (PE) and pulmonary arterial hypertension (PAH). Detailed family history interviews will be performed with all patients, and all enrolled patients will provide a blood sample for thrombophilia testing and for gene sequencing with the goal of identifying novel genetic variants that contribute to CTEPH risk.


Recruitment information / eligibility

Status Recruiting
Enrollment 260
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - CTEPH cohort: 1. Confirmed CTEPH based on having undergone PEA surgery. 2. Strongly suspected CTEPH based on right heart catheterization data showing mPAP>26 and PCWP<15, and imaging demonstrating chronic thromboembolic disease (either ventilation/perfusion scan, CT pulmonary angiography, or conventional pulmonary angiography). - PE cohort: 1. PE diagnosed by CT pulmonary angiography or ventilation/perfusion scan within the preceding 24 months. 2. No evidence of PH at the time of enrollment (based on absence of dyspnea, exertional chest pain, or exertional presyncope on history, lack of physical exam findings of PH or right heart failure, and lack of signs of PH on objective data including echocardiography and/or right heart catheterization). 3. No evidence of chronic thromboembolic disease at the time of enrollment (based on chronic appearing thrombus on CT pulmonary angiography or conventional pulmonary angiography, or based on prior high probability ventilation/perfusion scan showing a similar pattern of perfusion defects). - PAH cohort: 1. Diagnosis of group 1 PAH. 2. Prior normal or low probability ventilation/perfusion scan. 3. No reported history of prior VTE events. 4. If available, all prior evaluations for VTE (including CT pulmonary angiography and Doppler ultrasound exams) must also be negative. Exclusion Criteria: - Under the age of 18

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Blood Draw


Locations

Country Name City State
United States Intermountain Medical Center Murray Utah

Sponsors (1)

Lead Sponsor Collaborator
Intermountain Health Care, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rates of family history of VTE in relatives of CTEPH patients compared to PE and PAH patients in Intermountain populations through study completion, approximately 18 months
Secondary Characteristics of familial and, apparently, sporadic CTEPH in Intermountain populations through study completion, approximately 18 months
Secondary Estimates of prevalence of familial CTEPH in Intermountain populations through study completion, approximately 18 months
Secondary Heritability and penetrance patterns of familial CTEPH through study completion, approximately 18 months
Secondary Discovery and validation of genetic polymorphisms present in familial CTEPH patients through study completion, approximately 18 months
Secondary Identification of gene pathways that may be relevant to the development of CTEPH after actue PE through study completion, approximately 18 months
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