- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03470207
The Prospective Risk Factor Evaluation & Discovery In CTEPH Study (PREDICT PH)
The Prospective Risk Factor Evaluation and Discovery In Chronic Thromboembolic Pulmonary Hypertension Study
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Utah
-
Murray, Utah, United States, 84107
- Recruiting
- Intermountain Medical Center
-
Contact:
- David P Tomer, MS
- Phone Number: (801) 507-4694
- Email: David.Tomer@imail.org
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Principal Investigator:
- Mark W Dodson, MD PhD
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Sub-Investigator:
- Greg Elliott, MD
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Sub-Investigator:
- Lynette M Brown, MD PhD
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Sub-Investigator:
- Kirk Knowlton, MD
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Sub-Investigator:
- Matthew Rondina, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Post-Intervention Cohort (Aim 1)
This arm will not have the intervention of the implementation of the structured post-pulmonary embolism follow up protocol that is outlined in Aim 1.
|
|
Experimental: Pre-Intervention Cohort (Aim 3)
This arm will have the intervention of the implementation of the structured post-pulmonary embolism follow up protocol that is outlined in Aim 1.
|
Structured post-pulmonary embolism follow up protocol (outlined in Aim 1)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Chronic Thromboembolic Pulmonary Hypertension (CTEPH) diagnosis rate
Time Frame: Day of diagnosis of pulmonary embolism (PE) until 2 years after day of diagnosis of PE
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mark W Dodson, MD PhD, Intermountain Health Care, Inc.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1050516
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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