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The goal of this patient registry is to learn about the natural history in patients with chronic thromboembolic disease (CTD) and/or chronic thromboembolic pulmonary hypertension (CTEPH). The main question[s] it aims to answer are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chronic thromboembolic disease | Patients with chronic thromboembolic disease/pulmonary hypertension |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Survey | Other | Patients who received medical, surgical or interventional treatment for chronic thromboembolic pulmonary hypertension will be followed and given quality of life questionnaires. |
| Measure | Description | Time Frame |
|---|---|---|
| Total number of patients who survive | The total number of patients who are alive | Through study completion, an average of 5 years |
| Changes in exercise tolerance | Measured by 6-min walk test, which will be done approximately every 3 months at follow up per standard of care | Baseline to end of the study, an average of 5 years |
| Changes in supplemental oxygen use severity | Number of patients on supplemental oxygen, which will be recorded approximately every 3 months at follow up per standard of care. This will be compiled at the end of the study to provide overall change in measurement. | Baseline to end of the study, an average of 5 years |
| Changes in New York Heart Association (NYHA) functional class | Grading of patients by NYHA functional class, which include functional capacity and objective assessment. This will be compiled at the end of the study to provide overall change in measurement. | Baseline to end of the study, an average of 5 years |
| European Quality of Life Five Dimension (EQ-5D) - Scale Score | Assessment of quality of life will be measured using EQ-5D-5L. This instrument is a self-assessed, health-related, quality of life questionnaire that measures quality of life on a 5-component scale. The scores range from Level 1 to Level 5, with lower scores indicating a higher quality of life. This will be collected every 3 months and compiled at the end of the study to provide overall change in measurement. | Baseline to end of the study, an average of 5 years |
| Changes in patients' emPHasis-10 scores |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in CTEPH-/CTED- specific medication | The frequency and dose of medication specifically for management of CTEPH or CTED, which will be assessed approximately every 3 months as routine medical follow up. This will be compiled at the end of the study to assess overall change. | Baseline to end of the study, an average of 5 years |
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Inclusion Criteria:
Patients referred with CTED and/or CTEPH defined as:
Treatment with anticoagulation for ≥ 3 months before diagnosis of CTEPH or CTEPD without PH
Age ≥ 18 years
Exclusion Criteria:
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Patients with diagnosed chronic thromboembolic disease (CTED) or chronic thromboembolic pulmonary hypertension (CTEPH)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Miles Conrad, MD | Contact | (415) 353-1300 | miles.conrad@ucsf.edu | |
| Xiao Wu, MD | Contact | 628-286-7340 | xiao.wu@ucsf.edu |
| Name | Affiliation | Role |
|---|---|---|
| Miles Conrad, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Francisco | Recruiting | San Francisco | California | 94143 | United States |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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Assessed by the emPHasis-10 (pulmonary hypertension) instrument, which is an instrument specifically designed to assess the quality of life in patients with pulmonary hypertension. Each item will be scored from 0 to 5 where 0 was the best score. This will be collected every 3 months and compiled at the end of the study to assess overall change in measurement.
| Baseline to end of the study, an average of 5 years |
| Number of patients undergoing lung transplantation | Number of patients undergoing lung transplantation | Baseline to end of the study, an average of 5 years |
| History of undergoing pulmonary endarterectomy |
Number of patients undergoing pulmonary endarterectomy |
| Through study completion, an average of 5 years |
| History of undergoing pulmonary balloon angioplasty | Number of patients undergoing pulmonary balloon angioplasty | Through study completion, an average of 5 years |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |