Pulmonary EmbolismOPTALYSE-3DACNCT04113421
Quantitative 3-Dimensional Chest CT Vascular Reconstruction Before and After Anticoagulation for Pulmonary Embolism
An observational study of Pulmonary Embolism, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism
- What is being tested?
- Contrast-enhanced chest CT
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2019to 30 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Quantitative 3-Dimensional Chest CT Vascular Reconstruction Before and After Anticoagulation for Pulmonary Embolism (OPTALYSE-3DAC)
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.
Read more
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.
Read the detailed description
The pulmonary vascular response to ultrasound-facilitated, catheter-directed fibrinolysis for treatment of pulmonary embolism (PE) results in rapid improvement in patient symptoms and right ventricular (RV) recovery, while minimizing the risk of intracranial hemorrhage. The investigators recently completed an analysis of the chest computed tomographic (CT) data from the SEATTLE II Trial of ultrasound-facilitated, catheter-directed fibrinolysis for treatment of PE using a previously-validated 3-dimensional (3D) reconstruction technique pioneered at Brigham and Women's Hospital (BWH). This software-based 3D technique enables anatomic and structural resolution of the distal pulmonary arteries (microvasculature) far beyond the imaging capabilities of clinically utilized methods. This technique also provides a precise quantitation of RV volume and quantification of the perfusion of the proximal and distal pulmonary arteries. In our 3D reconstruction analysis of the multicenter, U.S.-based SEATTLE II Trial chest CT data, the investigators found that loss of intraparenchymal blood vessel volume was associated with RV enlargement and change in distal small vessel pulmonary artery perfusion predicted RV recovery with ultrasound-facilitated, catheter-directed fibrinolysis in subjects with acute PE. These data were presented at the American Heart Association (AHA) Annual Scientific Sessions in 2017 and have been submitted for publication.
While ultrasound-facilitated, catheter-directed fibrinolysis has been studied using this 3D reconstruction technique, the pulmonary vascular response in PE patients treated clinically with anticoagulation alone has not been. The investigators propose a study to evaluate inpatients diagnosed with acute PE, in whom clinical providers have already prescribed standard anticoagulation alone for treatment based on clinical grounds at Brigham and Women's Hospital, applying this 3-dimensional reconstruction technique to compare data from a standard clinical contrast-enhanced chest CT scan performed 48 hours after initiation of therapy and those data from the standard clinically-indicated baseline contrast-enhanced chest CT scan.
The specific aims for this proposed study are as follows:
Aim #1: To quantify the 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.
Hypothesis #1: The greatest change in pulmonary vascular perfusion following anticoagulation alone for acute PE will take place in the distal small (<5 mm2 cross-sectional area) pulmonary arteries compared with larger (>5 mm2 cross-sectional area) vessels. However, the magnitude of change will be less than that observed in our previously reported analysis focused on patients with acute PE undergoing ultrasound-facilitated, catheter-based fibrinolysis.
Aim #2: To quantify the CT-determined percent change in 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.
Hypothesis #2: RV volume will decrease over 48 hours of anticoagulation alone but the percent change will be less than that observed in our previously reported analysis focused on patients with acute PE undergoing ultrasound-facilitated, catheter-based fibrinolysis
- Conditions
- Pulmonary Embolism
- Being tested
- Contrast-enhanced chest CT
- Keywords
- pulmonary embolism, anticoagulation
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contrast-enhanced chest CTDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Contrast-enhanced chest CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 48 ± 6 hours
Secondary outcomes (1)
Change in RV volume
Percent change in RV volume using quantitative 3-D vascular reconstruction of baseline and follow-up (at 48 ± 6 hours) standard contrast-enhanced chest CTs.
Measured: 48 ± 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2019
- Study start1 Dec 2019
- Primary completion30 Dec 2023
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gregory Piazza, MD, MS, Brigham and Women's Hospital
- Investigators
- Gregory Piazza, MD, MS, Principal investigator, BWH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04113421
- Sponsor's protocol ID
- 2019P002124
- Acronym
- OPTALYSE-3DAC
- Status last verified
- Jan 2026
- First submitted
- 1 Oct 2019
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Will not participate in data sharing
Publications
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.
PubMed 30025734Piazza 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.
PubMed 26315743
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative 3-Dimensional Chest CT Vascular Reconstruction Before and After Anticoagulation for Pulmonary Embolism (OPTALYSE-3DAC)
- ClinicalTrials.gov ID
- NCT04113421
- Acronym / sponsor ID
- OPTALYSE-3DAC / 2019P002124
- Conditions
- Pulmonary Embolism
- Keywords
- pulmonary embolism, anticoagulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 2 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The pulmonary vascular response to ultrasound-facilitated, catheter-directed fibrinolysis for treatment of pulmonary embolism (PE) results in rapid improvement in patient symptoms and right ventricular (RV) recovery, while minimizing the risk of intracranial hemorrhage. The investigators recently completed an analysis of the chest computed tomographic (CT) data from the SEATTLE II Trial of ultrasound-facilitated, catheter-directed fibrinolysis for treatment of PE using a previously-validated 3-dimensional (3D) reconstruction technique pioneered at Brigham and Women's Hospital (BWH). This software-based 3D technique enables anatomic and structural resolution of the distal pulmonary arteries (microvasculature) far beyond the imaging capabilities of clinically utilized methods. This technique also provides a precise quantitation of RV volume and quantification of the perfusion of the proximal and distal pulmonary arteries. In our 3D reconstruction analysis of the multicenter, U.S.-based SEATTLE II Trial chest CT data, the investigators found that loss of intraparenchymal blood vessel volume was associated with RV enlargement and change in distal small vessel pulmonary artery perfusion predicted RV recovery with ultrasound-facilitated, catheter-directed fibrinolysis in subjects with acute PE. These data were presented at the American Heart Association (AHA) Annual Scientific Sessions in 2017 and have been submitted for publication.
While ultrasound-facilitated, catheter-directed fibrinolysis has been studied using this 3D reconstruction technique, the pulmonary vascular response in PE patients treated clinically with anticoagulation alone has not been. The investigators propose a study to evaluate inpatients diagnosed with acute PE, in whom clinical providers have already prescribed standard anticoagulation alone for treatment based on clinical grounds at Brigham and Women's Hospital, applying this 3-dimensional reconstruction technique to compare data from a standard clinical contrast-enhanced chest CT scan performed 48 hours after initiation of therapy and those data from the standard clinically-indicated baseline contrast-enhanced chest CT scan.
The specific aims for this proposed study are as follows:
Aim #1: To quantify the 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.
Hypothesis #1: The greatest change in pulmonary vascular perfusion following anticoagulation alone for acute PE will take place in the distal small (<5 mm2 cross-sectional area) pulmonary arteries compared with larger (>5 mm2 cross-sectional area) vessels. However, the magnitude of change will be less than that observed in our previously reported analysis focused on patients with acute PE undergoing ultrasound-facilitated, catheter-based fibrinolysis.
Aim #2: To quantify the CT-determined percent change in 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.
Hypothesis #2: RV volume will decrease over 48 hours of anticoagulation alone but the percent change will be less than that observed in our previously reported analysis focused on patients with acute PE undergoing ultrasound-facilitated, catheter-based fibrinolysis
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anticoagulation | – | Diagnostic Test: Contrast-enhanced chest CTInpatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contrast-enhanced chest CTA 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. | Diagnostic test | Anticoagulation |
Primary outcome
Perfusion of the pulmonary arteries
Time frame: 48 ± 6 hours
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.
1 secondary outcome
Change in RV volume
Time frame: 48 ± 6 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Background: PubMed 30025734Tapson 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.
- Background: PubMed 26315743Piazza 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.
- Individual participant dataSharing planned: No. Will not participate in data sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory Piazza, MD, MS principal investigator
BWH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Embolism, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perfusion of the pulmonary arteries (time frame: 48 ± 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04113421, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.