Chronic Thromboembolic Disease 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.
Conditions:
🦠 Chronic Thromboembolic Pulmonary Hypertension 🦠 Chronic Thromboembolic Disease
🗓️ Study Start (Actual) 1 August 2023
🗓️ Primary Completion (Estimated) 1 July 2028
✅ Study Completion (Estimated) 1 July 2028
👥 Enrollment (Estimated) 100
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 San Francisco, California, United States

📋 Eligibility Criteria

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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ 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 Registration Dates

  • First Submitted 24 April 2023
  • First Submitted that Met QC Criteria 24 April 2023
  • First Posted 6 May 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 14 August 2023
  • Last Update Posted 18 August 2023
  • Last Verified August 2023