Quantitative Assessment of RV Strain Using cMRI Following Catheter Intervention on PE

NCT03341208 | Unknown

• 1 other identifier: UArizonaIR
• Study Type: observational
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

Acute pulmonary embolism (PE) is a condition in which the vessels carrying blood to the lungs become suddenly blocked, usually by a blood clot. There are a number of adverse consequences that result, with one of the most significant being strain on the right side of the heart (which must push blood through the blocked arteries to the lungs). Although this strain on the right heart is very important, current methods for measuring it are flawed. The standard practice is to obtain an echocardiogram (ultrasound of the heart), from which indirect measurements of the size of the heart are used to make inferences about right heart strain. This method can help guide management in some patients, but it in not a sensitive test and does not provide detailed information. Patients with PE are treated with blood thinning medications. Some patients may be referred to the Interventional Radiology (IR) team for endovascular intervention, in which catheters are placed into the patient's vessels under radiologic guidance and advanced to the lungs to remove the clot entirely. Cardiac magnetic resonance imaging (MRI) is a well-established imaging technique that produces highly detailed images of the heart's structure and function, with no risks to patients of ionizing radiation or intravenous contrast. Cardiac MRI is far superior to echocardiogram in evaluation of the right side of the heart, however it has not been widely used in the evaluation of patients with PE. We propose that by using a fast MRI protocol, we will be able to detect right heart strain with more accuracy than echocardiogram. Furthermore, we hypothesize that MRI images obtained before and after IR catheter-directed therapy will demonstrate the degree to which strain is relieved with this treatment. Finally, we believe that using MRI may help to guide management of patients with PE by detecting early or mild heart strain before it progresses. In order to test these hypotheses, we plan to image PE patients who have been referred to the IR team with MRI. Patients recruited for this study will undergo two short MRI scans - one immediately before treatment, and one after completion of IR treatment (which lasts approximately 12-24 hours).

Conditions

Right Ventricular Failure; Pulmonary Embolism

Outcome Measures

Primary Outcomes (1)

• Measure RVEF prior to and after catheter directed therapy to remove pulmonary thromboembolus

  Will predict severity of PE and identify patients that would most benefit from catheter therapy

  2 years

Interventions

Cardiac Magnetic Resonance Imaging DIAGNOSTIC_TEST

Cardiac MRI will be performed before and after subject has undergone catheter directed therapy

Eligibility Criteria

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

Study Population

Approximately 10 patients will be recruited for the study. Participants will be patients who present to the emergency department or are inpatients in the hospital, who are found to have a diagnosis of acute pulmonary embolism (confirmed by computed tomography pulmonary angiography), and who have been referred to Interventional Radiology for evaluation for CDT. Patients appropriate for recruitment into this study will have large PEs involving lobar branches or more central segments of the pulmonary arteries. However, patients with massive PE (resulting in hemodynamic instability) will not be appropriate participants for this study.

You may qualify if:

• Participants will be patients who present to the emergency department or are inpatients in the hospital, who are found to have a diagnosis of acute pulmonary embolism (confirmed by computed tomography pulmonary angiography), and who have been referred to Interventional Radiology for evaluation for CDT. Patients appropriate for recruitment into this study will have large PEs involving lobar branches or more central segments of the pulmonary arteries.

Sponsors & Collaborators

• University of Arizona: lead

Related Publications (18)

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MeSH Terms

Conditions

Heart Failure; Pulmonary Embolism

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases

Study Officials

• Charles Hennemeyer, MD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shannon Urbina, BS

CONTACT

520-626-7500; Shannon.Urbina@bannerhealth.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Vascular and Interventional Radiology

Study Record Dates

• First Submitted: November 7, 2017
• First Posted: November 14, 2017
• Study Start: December 1, 2017
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: November 14, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share