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NCT03341208: RVEF
Quantitative Assessment of RV Strain Using cMRI Following Catheter Intervention on PE
trial testing Cardiac Magnetic Resonance Imaging in Right Ventricular Failure in 10 participants. Status unknown.
1 December 2019
Quick facts
| Lead sponsor | University of Arizona |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 10 |
| Start date | 1 December 2017 |
| Primary completion | 1 December 2019 |
| Estimated completion | 1 December 2019 |
Drugs / interventions tested
- Cardiac Magnetic Resonance Imaging
Conditions studied
- Right Ventricular Failure — all drugs for Right Ventricular Failure →
- Pulmonary Embolism — all drugs for Pulmonary Embolism →
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.
Verify or expand the search:
- PubMed search for NCT03341208
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03341208 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Arizona
- Last refreshed: 14 November 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03341208.
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