Pulmonary EmbolismSPESNCT01635257
Accuracy of Multi-organ Ultrasound for the Diagnosis of Pulmonary Embolism
An observational study of Pulmonary Embolism, run by Azienda Ospedaliero-Universitaria Careggi at 3 sites in Italy.
Trial summary
Patients with suspected Pulmonary Embolism (PE) and a high clinical probability or a high D-dimer level should undergo a second level diagnostic test such as Multidetector Computed Tomography Angiography (MCTPA). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Embolism
- What is being tested?
- Ultrasound scan
- How many people
- 357 participants
- Where
- 3 sitesItaly
- Study dates
- Jun 2012to Dec 2012
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients more than 18 years presenting to three emergency departments with clinical suspected pulmonary embolism. Clinical suspected pulmonary embolism is defined as new onset or worsening dyspnea, chest pain, syncope or shock/Hypotension without an alternative obvious cause
Who may be able to join
- Patients with clinical suspected pulmonary embolism
- Simplified Well's score>4 (PE likely) or D-dimer value ≥500ng/ml
- Patients that undergo MCTPA in the Emergency Department for suspected pulmonary embolism
Who cannot join
- Refused consent
- Less than 18 years old
- Not possible to perform ultrasound scan within 3 hours before MCTPA
Trial locations and contacts
3 sites in 1 country.
Italy3 sites
Emergency Department Azienda Ospedaliera Universitaria Careggi
Florence, Tuscany, 50134
Department of Emergency Medicine, Pierantoni Morgagni Hospital
Forlì, 47121
Department of Emergency Medicine, San Luigi Gonzaga University Hospital
Torino, 10043
About this study
Official title: Accuracy of Multi-organ Ultrasound (Venous, Cardiac and Thoracic) for the Diagnosis of Pulmonary Embolism: Suspected Pulmonary Embolism Sonographic Assessment (SPES) Multicenter Prospective Study
Patients with suspected Pulmonary Embolism (PE) and a high clinical probability or a high D-dimer level should undergo a second level diagnostic test such as Multidetector Computed Tomography Angiography (MCTPA). Unfortunately MCTPA involves radiation exposure, is expensive, is not feasible in unstable patients and has contraindications. UltraSound (US) is safe and rapidly available even in unstable patients. Many authors evaluated the diagnostic role of Compression Ultrasound Scan (CUS) for detecting limbs Deep Vein Thrombosis (DVT), TransThoracic Echocardiography (TTE) for detecting Right Ventricular Dysfunction (RVD) or Thoracic UltraSound (TUS) for detecting subpleural infarcts in patients with suspected PE. No previous studies have investigated the diagnostic accuracy of CUS, TTE and TUS combined (multiorgan US) for the diagnosis of PE. This study evaluates the diagnostic accuracy of multiorgan US.
Methods. Consecutive patients that underwent MCTPA in the Emergency Department for clinical suspicion of PE and with a simplified Well's score>4 (PE likely) or with a D-dimer value ≥500ng/ml were enrolled in the study. MCTPA was considered the gold standard for PE diagnosis. A multiorgan US was performed by an emergency physician sonographer before MCTPA. PE was considered echographically present if CUS was positive for DVT or TTE was positive for RVD or at least one pulmonary subpleural infarct was detected with TUS. The accuracy of the single and multiorgan US was calculated.
- Conditions
- Pulmonary Embolism
- Being tested
- Ultrasound scan
- Keywords
- pulmonary embolism diagnosis, ultrasound
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound scanOther
A multiorgan ultrasound was performed by an emergency physician sonographer before MCTPA. Pulmonary embolism was considered echographically present if compression ultrasound was positive for deep vein thrombosis or transthoracic-echocardiography was positive for right ventricular dysfunction or at least one pulmonary subpleural infarct was detected with thoracic ultrasound.
| Study group | Role | What they receive |
|---|---|---|
| suspected pulmonary embolism patients | patients with clinical suspicion of PE and with a simplified Well's score>4 (PE likely) or with a D-dimer value ≥500ng/ml presenting to the emergency departments of Careggi University Hospital (Firenze), of San Luigi Gonzaga University Hospital (Torino) of Ospedale Pierantoni-Morgagni (Forlì) Receives: Other: Ultrasound scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of ultrasound for the diagnosis of pulmonary embolism
Sensitivity, specificity, negative and positive predictive value, negative and positive likelihood ratio of limb, cardiac, thoracic and multi-organ ultrasound for the diagnosis of pulmonary embolism in the emergency department considering as gold standard the Multidetector Computed Tomography Angiography (MCTPA)
Measured: The goldstandard for PE diagnosis is the MCTPA performed within 24 hours from ED presentation. The recruiting period is 5 months. There is not a follow-up for the included patients.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2012 (estimated)
- Study startJun 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- 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
- 357 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria Careggi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peiman Nazerian, Azienda Ospedaliero-Universitaria Careggi
- Investigators
- Stefano Grifoni, MD, Study chair, Director of Pronto Soccorso generale of AUO Careggi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01635257
- Sponsor's protocol ID
- 080974
- Acronym
- SPES
- Status last verified
- Mar 2013
- First submitted
- 1 Jul 2012
- Last updated
- 18 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Nazerian P, Vanni S, Volpicelli G, Gigli C, Zanobetti M, Bartolucci M, Ciavattone A, Lamorte A, Veltri A, Fabbri A, Grifoni S. Accuracy of point-of-care multiorgan ultrasonography for the diagnosis of pulmonary embolism. Chest. 2014 May;145(5):950-957. doi: 10.1378/chest.13-1087.
PubMed 24092475
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Multi-organ Ultrasound (Venous, Cardiac and Thoracic) for the Diagnosis of Pulmonary Embolism: Suspected Pulmonary Embolism Sonographic Assessment (SPES) Multicenter Prospective Study
- ClinicalTrials.gov ID
- NCT01635257
- Acronym / sponsor ID
- SPES / 080974
- Conditions
- Pulmonary Embolism
- Keywords
- pulmonary embolism diagnosis, ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 357 participants (actual)
- Lead sponsor
- Azienda Ospedaliero-Universitaria CareggiUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 9 Jul 2012 (estimated)
- 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.
Patients with suspected Pulmonary Embolism (PE) and a high clinical probability or a high D-dimer level should undergo a second level diagnostic test such as Multidetector Computed Tomography Angiography (MCTPA). Unfortunately MCTPA involves radiation exposure, is expensive, is not feasible in unstable patients and has contraindications. UltraSound (US) is safe and rapidly available even in unstable patients. Many authors evaluated the diagnostic role of Compression Ultrasound Scan (CUS) for detecting limbs Deep Vein Thrombosis (DVT), TransThoracic Echocardiography (TTE) for detecting Right Ventricular Dysfunction (RVD) or Thoracic UltraSound (TUS) for detecting subpleural infarcts in patients with suspected PE. No previous studies have investigated the diagnostic accuracy of CUS, TTE and TUS combined (multiorgan US) for the diagnosis of PE. This study evaluates the diagnostic accuracy of multiorgan US.
Methods. Consecutive patients that underwent MCTPA in the Emergency Department for clinical suspicion of PE and with a simplified Well's score>4 (PE likely) or with a D-dimer value ≥500ng/ml were enrolled in the study. MCTPA was considered the gold standard for PE diagnosis. A multiorgan US was performed by an emergency physician sonographer before MCTPA. PE was considered echographically present if CUS was positive for DVT or TTE was positive for RVD or at least one pulmonary subpleural infarct was detected with TUS. The accuracy of the single and multiorgan US was calculated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| suspected pulmonary embolism patients | – | Other: Ultrasound scanpatients with clinical suspicion of PE and with a simplified Well's score>4 (PE likely) or with a D-dimer value ≥500ng/ml presenting to the emergency departments of Careggi University Hospital (Firenze), of San Luigi Gonzaga University Hospital (Torino) of Ospedale Pierantoni-Morgagni (Forlì) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients more than 18 years presenting to three emergency departments with clinical suspected pulmonary embolism. Clinical suspected pulmonary embolism is defined as new onset or worsening dyspnea, chest pain, syncope or shock/Hypotension without an alternative obvious cause
Key inclusion criteria (3 listed)
- Patients with clinical suspected pulmonary embolism
- Simplified Well's score>4 (PE likely) or D-dimer value ≥500ng/ml
- Patients that undergo MCTPA in the Emergency Department for suspected pulmonary embolism
Key exclusion criteria (3 listed)
- Refused consent
- Less than 18 years old
- Not possible to perform ultrasound scan within 3 hours before MCTPA
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 |
|---|---|---|
| Ultrasound scanA multiorgan ultrasound was performed by an emergency physician sonographer before MCTPA. Pulmonary embolism was considered echographically present if compression ultrasound was positive for deep vein thrombosis or transthoracic-echocardiography was positive for right ventricular dysfunction or at least one pulmonary subpleural infarct was detected with thoracic ultrasound. | Other | suspected pulmonary embolism patients |
Primary outcome
Accuracy of ultrasound for the diagnosis of pulmonary embolism
Time frame: The goldstandard for PE diagnosis is the MCTPA performed within 24 hours from ED presentation. The recruiting period is 5 months. There is not a follow-up for the included patients.
Sensitivity, specificity, negative and positive predictive value, negative and positive likelihood ratio of limb, cardiac, thoracic and multi-organ ultrasound for the diagnosis of pulmonary embolism in the emergency department considering as gold standard the Multidetector Computed Tomography Angiography (MCTPA)
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 18 Mar 2013.
- Derived from this study: PubMed 24092475Nazerian P, Vanni S, Volpicelli G, Gigli C, Zanobetti M, Bartolucci M, Ciavattone A, Lamorte A, Veltri A, Fabbri A, Grifoni S. Accuracy of point-of-care multiorgan ultrasonography for the diagnosis of pulmonary embolism. Chest. 2014 May;145(5):950-957. doi: 10.1378/chest.13-1087.
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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.
Stefano Grifoni, MD study chair
Director of Pronto Soccorso generale of AUO Careggi
3 sites 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 Azienda Ospedaliero-Universitaria Careggi at 3 sites in Italy.
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 3 inclusion and 3 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 18 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. 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?
Accuracy of ultrasound for the diagnosis of pulmonary embolism (time frame: The goldstandard for PE diagnosis is the MCTPA performed within 24 hours from ED presentation. The recruiting period is 5 months. There is not a follow-up for the included patients.). 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 NCT01635257, which also lists 1 linked publication.
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 18 Mar 2013.