Quantitative 3-Dimensional Chest CT Vascular Reconstruction Before and After Anticoagulation for Pulmonary Embolism

NCT04113421 | Completed

• 1 other identifier: 2019P002124
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Design: U.S.-based, single-center, proof-of-concept study Brief Description: A standard clinical contrast-enhanced chest CT scan performed 48 hours after clinically-indicated standard anticoagulation will be compared with a standard clinically-indicated baseline contrast-enhanced chest CT scan using a previously-studied and previously-validated 3-dimensional reconstruction technique to assess changes in the pulmonary vasculature in patients with acute pulmonary embolism (PE). This previously-studied and previously-validated 3-dimensional reconstruction technique has been used to assess the response of the pulmonary vasculature to catheter-based fibrinolysis in acute PE as well as to assess the pulmonary vasculature in a number of chronic lung diseases. However, the pulmonary vascular response to standard anticoagulation for acute PE has not been assessed previously. Purpose: To compare the pulmonary vasculature before and after standard clinically-indicated anticoagulation for acute PE using a previously-studied and previously-validated 3-dimensional reconstruction technique applied with a standard clinically-indicated baseline contrast-enhanced chest CT scan (used to diagnose the acute PE) and a standard clinical contrast-enhanced chest CT scan performed 48 hours later as indicated by the study protocol. Population: Inpatients diagnosed with acute PE, in whom clinical providers have prescribed standard anticoagulation alone for treatment based on clinical grounds at Brigham and Women's Hospital. Enrollment: 10 subjects with acute PE Clinical Site Location: Single-center, Brigham and Women's Hospital Study Duration: 12 months Primary Imaging Outcome: CT-determined percent change in perfusion of the pulmonary vasculature from baseline to 48 hours in inpatients diagnosed with acute PE, in whom clinical providers have prescribed standard anticoagulation alone for treatment based on clinical grounds at Brigham and Women's Hospital. Secondary Imaging Outcome: CT-determined percent change in right ventricular (RV) volume from baseline to 48 hours in inpatients diagnosed with acute PE, in whom clinical providers have prescribed standard anticoagulation alone for treatment based on clinical grounds at Brigham and Women's Hospital.

Conditions

Pulmonary Embolism

Keywords

pulmonary embolism; anticoagulation

Outcome Measures

Primary Outcomes (1)

• Perfusion of the pulmonary arteries

  Percent change in perfusion of the pulmonary arteries using quantitative 3-D vascular reconstruction of baseline and follow-up (at 48 ± 6 hours) standard contrast-enhanced chest CTs.

  48 ± 6 hours

Secondary Outcomes (1)

• Change in RV volume

  48 ± 6 hours

Study Arms (1)

Anticoagulation

Inpatients diagnosed with acute PE, in whom clinical providers have elected to prescribe anticoagulation alone for treatment based on clinical grounds at BWH. In this population, a single follow-up contrast-enhanced chest CT will be performed to compare off-line with the contrast-enhanced chest CT done at baseline for the diagnosis of PE.

Diagnostic Test: Contrast-enhanced chest CT

Interventions

Contrast-enhanced chest CT DIAGNOSTIC_TEST

A single follow-up contrast-enhanced chest CT to compare off-line with the contrast-enhanced chest CT done at baseline for the diagnosis of PE.

Anticoagulation

Eligibility Criteria

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

Study Population

Inpatients diagnosed with acute PE, in whom clinical providers have elected to prescribe anticoagulation alone for treatment based on clinical grounds at BWH.

You may qualify if:

• 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.

You may not qualify if:

• Serum creatinine greater than 2 mg/dL
• GFR \< 60 mL/min
• Pregnancy (pregnancy test will have been done as standardly required by Radiology before the initial clinically-indicated, clinically-protocolled chest CT)
• Contrast allergy
• Treatment with any fibrinolytics-based technique, or surgical/ catheter embolectomy
• 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.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (2)

• Tapson VF, Sterling K, Jones N, Elder M, Tripathy U, Brower J, Maholic RL, Ross CB, Natarajan K, Fong P, Greenspon L, Tamaddon H, Piracha AR, Engelhardt T, Katopodis J, Marques V, Sharp ASP, Piazza G, Goldhaber SZ. A Randomized Trial of the Optimum Duration of Acoustic Pulse Thrombolysis Procedure in Acute Intermediate-Risk Pulmonary Embolism: The OPTALYSE PE Trial. JACC Cardiovasc Interv. 2018 Jul 23;11(14):1401-1410. doi: 10.1016/j.jcin.2018.04.008.

  PMID: 30025734 BACKGROUND

• Piazza G, Hohlfelder B, Jaff MR, Ouriel K, Engelhardt TC, Sterling KM, Jones NJ, Gurley JC, Bhatheja R, Kennedy RJ, Goswami N, Natarajan K, Rundback J, Sadiq IR, Liu SK, Bhalla N, Raja ML, Weinstock BS, Cynamon J, Elmasri FF, Garcia MJ, Kumar M, Ayerdi J, Soukas P, Kuo W, Liu PY, Goldhaber SZ; SEATTLE II Investigators. A Prospective, Single-Arm, Multicenter Trial of Ultrasound-Facilitated, Catheter-Directed, Low-Dose Fibrinolysis for Acute Massive and Submassive Pulmonary Embolism: The SEATTLE II Study. JACC Cardiovasc Interv. 2015 Aug 24;8(10):1382-1392. doi: 10.1016/j.jcin.2015.04.020.

  PMID: 26315743 BACKGROUND

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

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

Study Officials

• Gregory Piazza, MD, MS

  BWH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Director, Thrombosis Research Group

Study Record Dates

• First Submitted: October 1, 2019
• First Posted: October 2, 2019
• Study Start: December 1, 2019
• Primary Completion: December 30, 2023
• Study Completion: November 30, 2025
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)