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NCT03341208: RVEF

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

Status unknown Last updated 14 November 2017
What this trial tests

trial testing Cardiac Magnetic Resonance Imaging in Right Ventricular Failure in 10 participants. Status unknown.

Timeline
1 December 2017
Primary endpoint
1 December 2019
1 December 2019

Quick facts

Lead sponsorUniversity of Arizona
StatusStatus unknown
Study typeOBSERVATIONAL
Enrollment10
Start date1 December 2017
Primary completion1 December 2019
Estimated completion1 December 2019

Drugs / interventions tested

Conditions studied

Sponsor

University of Arizona

Who can join

18 and older, any sex, with Right Ventricular Failure or Pulmonary Embolism. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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