Chronic Thromboembolic Pulmonary Hypertension Clinical Trial
— PREDICT PHOfficial title:
The Prospective Risk Factor Evaluation and Discovery In Chronic Thromboembolic Pulmonary Hypertension Study
NCT number | NCT03470207 |
Other study ID # | 1050516 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | April 17, 2018 |
Est. completion date | August 2021 |
This research study wants to find markers in the blood that may help to predict a patient's
future risk of developing a disease called CTEPH. The study also wants to see if active
monitoring for signs and symptoms of CTEPH after a pulmonary embolism (a blood clot in the
lungs) can improve the diagnosis of CTEPH.
Patients who enroll in this study will have periodic blood draws and clinic and/or phone
follow-up to monitor for signs and symptoms of CTEPH. Patients' medical records will also be
reviewed for information related to pulmonary embolisms and/or CTEPH.
Status | Recruiting |
Enrollment | 130 |
Est. completion date | August 2021 |
Est. primary completion date | May 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: i. Age = 18 years. ii. Presence of pulmonary embolism (PE) objectively diagnosed by ventilation/perfusion (V/Q) scan or computed tomography pulmonary angiography (CTPA). iii. Plus one of: - Prior history of PE before the index event (predicted 2-year incidence of chronic thromboembolic pulmonary hypertension (CTEPH) of 35%). - Transthoracic echocardiogram (TTE) performed within 72 hours of PE diagnosis demonstrating a maximum velocity of the tricuspid regurgitant (TR) jet = 3.0 meters/second (predicted 2-year incidence of CTEPH of approximately 25%). - CTPA demonstrating involvement of one of the main pulmonary arteries with PE (predicted 2-year incidence of CTEPH of approximately 15%). - CTEPH prediction score = 6 (this score is based on several clinical factors, including unprovoked nature of the PE, presence of right ventricular dysfunction by CTPA or TTE, presence of hypothyroidism or diabetes, and thrombolytic therapy for PE). Exclusion Criteria: i. The patient previously met diagnostic criteria for pulmonary hypertension of any cause. ii. Presence of significant left ventricular systolic dysfunction (defined by left ventricular ejection fraction = 45% by TTE), or left sided valvular disease (including mitral or aortic regurgitation or stenosis). iii. Age > 85 years. iv. The presence of metastatic malignancy (due to the expected limitation of lifespan to less than the study follow-up period of 2 years). v. The presence of a significant psychiatric disorder or significant cognitive impairment, which would make follow-up and/or symptom reporting difficult. vi. Inability or unwillingness to attend follow-up clinic appointments at Intermountain Medical Center (including geographical, financial, and insurance limitations). |
Country | Name | City | State |
---|---|---|---|
United States | Intermountain Medical Center | Murray | Utah |
Lead Sponsor | Collaborator |
---|---|
Mark W. Dodson |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Chronic Thromboembolic Pulmonary Hypertension (CTEPH) diagnosis rate | Number of CTEPH diagnoses divided by number of patients in each cohort (pre- and post-intervention) | Day of diagnosis of pulmonary embolism (PE) until 2 years after day of diagnosis of PE |
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