The Prospective Risk Factor Evaluation & Discovery In CTEPH Study

NCT03470207 | Unknown DMC

• 1 other identifier: 1050516
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Chronic Thromboembolic Pulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Post-Intervention Cohort (Aim 1)

NO INTERVENTION

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.

Pre-Intervention Cohort (Aim 3)

EXPERIMENTAL

This arm will have the intervention of the implementation of the structured post-pulmonary embolism follow up protocol that is outlined in Aim 1.

Procedure: Post-pulmonary embolism follow up protocol

Interventions

Post-pulmonary embolism follow up protocol PROCEDURE

Structured post-pulmonary embolism follow up protocol (outlined in Aim 1)

Pre-Intervention Cohort (Aim 3)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• Mark W. Dodson: lead

Study Sites (1)

Intermountain Medical Center

Murray, Utah, 84107, United States

RECRUITING

Study Officials

• Mark W Dodson, MD PhD

  Intermountain Health Care, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Valerie T Aston, MBA

CONTACT

801-507-4606; valerie.aston@imail.org

David P Tomer, MS

CONTACT

801-507-4694; David.Tomer@imail.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Director, CTEPH Program

Study Record Dates

• First Submitted: March 12, 2018
• First Posted: March 19, 2018
• Study Start: April 17, 2018
• Primary Completion: May 1, 2021
• Study Completion: August 1, 2021
• Last Updated: May 17, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Available: After the end of the study For how long: Indefinite
• Access Criteria: Appropriate data sharing agreements must be established with Intermountain Healthcare prior to any sharing of individual participant data.

Locations

US (1)