- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05843500
Chronic Thromboembolic Disease Registry
August 14, 2023 updated by: University of California, San Francisco
Chronic Thromboembolic Disease: A Prospective Registry
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:
- Long-term outcome after various types of treatment, including medication, balloon pulmonary angioplasty, and pulmonary endarterectomy
- Effect of treatment on patient's quality of life and exercise tolerance Participants will be followed longitudinally to assess their health outcomes and quality of life via chart review and health quality surveys.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Miles Conrad, MD
- Phone Number: (415) 353-1300
- Email: miles.conrad@ucsf.edu
Study Contact Backup
- Name: Xiao Wu, MD
- Phone Number: 628-286-7340
- Email: xiao.wu@ucsf.edu
Study Locations
-
-
California
-
San Francisco, California, United States, 94143
- Recruiting
- University of California San Francisco
-
Contact:
- Xiao Wu, MD
- Phone Number: 628-286-7340
- Email: xiao.wu@ucsf.edu
-
Contact:
- Miles Conrad, MD
- Phone Number: 415-353-1300
- Email: miles.conrad@ucsf.edu
-
Principal Investigator:
- Miles Conrad, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients with diagnosed chronic thromboembolic disease (CTED) or chronic thromboembolic pulmonary hypertension (CTEPH)
Description
Inclusion Criteria:
Patients referred with CTED and/or CTEPH defined as:
- Mean pulmonary arterial pressure (mPAP) > 20 mmHg at rest with pulmonary vascular resistance (PVR) > 2 Wood units (WU); or if mPAP ≤ 20 mmHg or PVR ≤ 2 WU at rest, have exercise limitations from chronic thromboembolic pulmonary disease (CTEPD) without pulmonary hypertension (PH)
- Radiologic finding of chronic thromboembolic disease, including abnormal ventilation perfusion scan, pulmonary angiogram, computer tomographic pulmonary angiogram, or magnetic resonance pulmonary angiogram
- Post-embolic exercise intolerance and evidence of chronic thromboembolic disease in the absence of resting pulmonary hypertension
- Treatment with anticoagulation for ≥ 3 months before diagnosis of CTEPH or CTEPD without PH
- Age ≥ 18 years
Exclusion Criteria:
- Main cause of PH other than World Health Organization (WHO) group 4 (CTEPH)
- Patient's refusal to participate in clinical research and/or receive intervention
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Chronic thromboembolic disease
Patients with chronic thromboembolic disease/pulmonary hypertension
|
Patients who received medical, surgical or interventional treatment for chronic thromboembolic pulmonary hypertension will be followed and given quality of life questionnaires.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total number of patients who survive
Time Frame: Through study completion, an average of 5 years
|
The total number of patients who are alive
|
Through study completion, an average of 5 years
|
Changes in exercise tolerance
Time Frame: Baseline to end of the study, an average of 5 years
|
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
Time Frame: Baseline to end of the study, an average of 5 years
|
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
Time Frame: Baseline to end of the study, an average of 5 years
|
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
Time Frame: Baseline to end of the study, an average of 5 years
|
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
|
Number of patients undergoing lung transplantation
Time Frame: Baseline to end of the study, an average of 5 years
|
Number of patients undergoing lung transplantation
|
Baseline to end of the study, an average of 5 years
|
Changes in patients' emPHasis-10 scores
Time Frame: Baseline to end of the study, an average of 5 years
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
History of undergoing pulmonary endarterectomy
Time Frame: Through study completion, an average of 5 years
|
Number of patients undergoing pulmonary endarterectomy
|
Through study completion, an average of 5 years
|
History of undergoing pulmonary balloon angioplasty
Time Frame: Through study completion, an average of 5 years
|
Number of patients undergoing pulmonary balloon angioplasty
|
Through study completion, an average of 5 years
|
Changes in CTEPH-/CTED- specific medication
Time Frame: Baseline to end of the study, an average of 5 years
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Miles Conrad, MD, University of California, San Francisco
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2023
Primary Completion (Estimated)
July 1, 2028
Study Completion (Estimated)
July 1, 2028
Study Registration Dates
First Submitted
April 24, 2023
First Submitted That Met QC Criteria
April 24, 2023
First Posted (Actual)
May 6, 2023
Study Record Updates
Last Update Posted (Actual)
August 18, 2023
Last Update Submitted That Met QC Criteria
August 14, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 23-38534
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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