The Prospective Risk Factor Evaluation & Discovery In CTEPH Study

Status unconfirmed · Not applicable

Conditions studied: Chronic Thromboembolic Pulmonary Hypertension

In brief

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.

Key facts

Study ID

NCT03470207

Run by

Mark W. Dodson

People needed

130

Starts

2018-04-17

Expected to finish

2021-08-01

Last updated by the study team

2019-05-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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).

Where it is running

• Intermountain Medical Center — Murray, Utah, United States (enrolling)

Full record on ClinicalTrials.gov

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