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

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

Study Contact Backup

Study Locations

    • California
      • San Francisco, California, United States, 94143
        • Recruiting
        • University of California San Francisco
        • Contact:
        • Contact:
        • 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:

    1. 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)
    2. Radiologic finding of chronic thromboembolic disease, including abnormal ventilation perfusion scan, pulmonary angiogram, computer tomographic pulmonary angiogram, or magnetic resonance pulmonary angiogram
    3. 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

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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