Status:
UNKNOWN
The Prospective Risk Factor Evaluation & Discovery In CTEPH Study
Lead Sponsor:
Mark W. Dodson
Conditions:
Chronic Thromboembolic Pulmonary Hypertension
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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...
Detailed Description
Chronic thromboembolic pulmonary hypertension (CTEPH) is due to non-resolution of pulmonary embolism (PE), and is the most serious long-term sequela of PE. Without treatment, CTEPH leads to progressiv...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
April 17 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2021
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT03470207
Start Date
April 17 2018
End Date
August 1 2021
Last Update
May 17 2019
Active Locations (1)
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1
Intermountain Medical Center
Murray, Utah, United States, 84107