Recruiting

Observational Study

Sponsor:

Mark W. Dodson

Code:

NCT03470207

Conditions

Chronic Thromboembolic Pulmonary Hypertension

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Post-pulmonary embolism follow up protocol

Study Details

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

Study ID

NCT03470207

Start date

Apr 17, 2018

Status verified date

May, 2019

Completion date

Aug, 2021

Anticipated

Primary completion date

May, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

130 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

Arms

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.

Interventions

Post-pulmonary embolism follow up protocol

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

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Locations

Intermountain Medical Center

Recruiting

Murray, Utah, United States, 84107

Contacts

Principal Investigator:

Mark W Dodson, MD PhD

More Information

Sponsor

Mark W. Dodson

Last update posted

May 17, 2019

Last verified

May, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Mark W. Dodson on 2019-05-17.