3D CT imaging of pulmonary blood vessels before and after anticoagulation for pulmonary embolism
Quantitative 3-Dimensional Chest CT Vascular Reconstruction Before and After Anticoagulation for Pulmonary Embolism (OPTALYSE-3DAC)
This study is trying to see how standard blood-thinning treatment affects the blood vessels in the lungs of patients with acute pulmonary embolism by comparing CT scans taken before and after the treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT04113421 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess changes in the pulmonary vasculature in patients diagnosed with acute pulmonary embolism (PE) who are treated with standard anticoagulation. It involves performing a contrast-enhanced chest CT scan 48 hours after anticoagulation and comparing it with a baseline CT scan. The study utilizes a validated 3-dimensional reconstruction technique to analyze the pulmonary vascular response, which has previously been applied in other contexts but not specifically for standard anticoagulation in acute PE. The goal is to better understand how anticoagulation affects the pulmonary vasculature and right ventricular function.
Who should consider this trial
Good fit: Ideal candidates include inpatients over 18 years old diagnosed with acute pulmonary embolism who are receiving anticoagulation treatment and meet specific imaging criteria.
Not a fit: Patients with renal impairment, pregnancy, contrast allergies, or those requiring alternative treatments like fibrinolytics or embolectomy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of anticoagulation effects on pulmonary vasculature, potentially leading to improved treatment strategies for patients with pulmonary embolism.
How similar studies have performed: While this approach has been validated in other contexts, the specific application of 3D reconstruction for assessing pulmonary vascular response to anticoagulation in acute PE is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Inpatients diagnosed with acute PE, in whom clinical providers have elected to prescribe anticoagulation alone for treatment based on clinical grounds at BWH. * Eligibility for the study will include patients over the age of 18 with bilateral proximal PE on CT (filling defect in ≥ 1 main, lobar, or segmental pulmonary artery), PE symptom duration ≤ 14 days, RV-to-LV diameter ratio ≥ 0.9 on contrast-enhanced chest CT, and a clinically-determined decision to pursue treatment with anticoagulation alone. Exclusion Criteria: 1. Serum creatinine greater than 2 mg/dL 2. GFR \< 60 mL/min 3. Pregnancy (pregnancy test will have been done as standardly required by Radiology before the initial clinically-indicated, clinically-protocolled chest CT) 4. Contrast allergy 5. Treatment with any fibrinolytics-based technique, or surgical/ catheter embolectomy 6. Expected hospital stay \< 48 hours. The length of stay will be determined by the treating provider prior to enrollment. Subjects will not extend their stay to 48 hours if they are deemed ready for discharge prior to the time.
Where this trial is running
Boston, Massachusetts
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Gregory Piazza, MD, MS — Bwh
- Study coordinator: Gregory Piazza, MD, MS
- Email: gpiazza@partners.org
- Phone: 6177326984
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.