Pulmonary EmbolismPROTECTNCT00880737
Prognostic Value of Computed Tomography (CT) Scan in Hemodynamically Stable Patients With Acute Symptomatic Pulmonary Embolism
An observational study of Pulmonary Embolism, run by Carlos III Health Institute at 1 site in Spain.
Trial summary
The objectives of the PROTECT study are: To assess the role of CT pulmonary angiography in the risk stratification of hemodynamically stable patients with acute symptomatic pulmonary embolism (PE). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism
- How many people
- 850 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2009to Jun 2011
- 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: Hemodynamically stable outpatients with suspicion of pulmonary embolism, confirmed by objective testing
Who may be able to join
- Acute symptomatic Pulmonary Embolism (PE) confirmed by:
- CT pulmonary angiography positive for PE
- Ventilation/ perfusion lung scan with high likelihood of PE (according to PIOPED criteria)
- V/Q ventilation/ perfusion lung scan inconclusive for PE or negative CT pulmonary angiography in a patient with thoracic symptoms and a lower limb ultrasound showing a positive diagnosis for deep vein thrombosis.
Who cannot join
- Contraindication for CT pulmonary angiography (allergy to iodine contrasts or creatinin clearance < 30 ml/min).
- Informed consent not obtained.
- Pregnancy.
- Life expectancy of less than 3 months.
- Hemodynamic unstability defined as SBP < 90 mm Hg, need for cardiopulmonary reanimation, need for vasoactive drugs or orotracheal intubation.
- Thrombectomy, insertion of filter in the cava vein, or need for fibrinolytic treatment for PE episode.
- Participation in another clinical trial for treatment of PE.
Trial locations and contacts
1 site in 1 country.
About this study
The objectives of the PROTECT study are:
- To assess the role of CT pulmonary angiography in the risk stratification of hemodynamically stable patients with acute symptomatic pulmonary embolism (PE).
- To assess the role of transthoracic echocardiography in the risk stratification of hemodynamically stable patients with acute symptomatic PE.
- To assess the role of 2 biomarkers (troponin and brain natriuretic peptide) in the risk stratification of hemodynamically stable patients with acute symptomatic PE.
- To assess the role of the Pulmonary Embolism Severity Index (PESI) in the risk stratification of hemodynamically stable patients with acute symptomatic PE.
- To assess the combined role of CT pulmonary angiography, transthoracic echocardiography, PESI, troponin I and brain natriuretic peptide in the risk stratification of hemodynamically stable patients with acute symptomatic PE.
- Conditions
- Pulmonary Embolism
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Stable PE patients | Hemodynamically stable patients with acute symptomatic pulmonary embolism |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome considered will be death by any cause in the month following diagnosis.
Measured: 30 days after PE diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2009 (estimated)
- Study startFeb 2009
- Primary completionJun 2011
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
- 850 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carlos III Health Institute
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00880737
- Sponsor's protocol ID
- FIS 2008
- Acronym
- PROTECT
- Status last verified
- Feb 2010
- First submitted
- 13 Apr 2009
- Last updated
- 15 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lankeit M, Jimenez D, Kostrubiec M, Dellas C, Kuhnert K, Hasenfuss G, Pruszczyk P, Konstantinides S. Validation of N-terminal pro-brain natriuretic peptide cut-off values for risk stratification of pulmonary embolism. Eur Respir J. 2014 Jun;43(6):1669-77. doi: 10.1183/09031936.00211613. Epub 2014 Mar 13.
PubMed 24627529
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Computed Tomography (CT) Scan in Hemodynamically Stable Patients With Acute Symptomatic Pulmonary Embolism
- ClinicalTrials.gov ID
- NCT00880737
- Acronym / sponsor ID
- PROTECT / FIS 2008
- Conditions
- Pulmonary Embolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 850 participants (estimated)
- Lead sponsor
- Carlos III Health InstituteOther government
- Study start
- Feb 2009
- Primary completion
- Jun 2011 (actual)
- First posted
- 14 Apr 2009 (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.
The objectives of the PROTECT study are:
- To assess the role of CT pulmonary angiography in the risk stratification of hemodynamically stable patients with acute symptomatic pulmonary embolism (PE).
- To assess the role of transthoracic echocardiography in the risk stratification of hemodynamically stable patients with acute symptomatic PE.
- To assess the role of 2 biomarkers (troponin and brain natriuretic peptide) in the risk stratification of hemodynamically stable patients with acute symptomatic PE.
- To assess the role of the Pulmonary Embolism Severity Index (PESI) in the risk stratification of hemodynamically stable patients with acute symptomatic PE.
- To assess the combined role of CT pulmonary angiography, transthoracic echocardiography, PESI, troponin I and brain natriuretic peptide in the risk stratification of hemodynamically stable patients with acute symptomatic PE.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stable PE patients | – | –Hemodynamically stable patients with acute symptomatic pulmonary embolism |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hemodynamically stable outpatients with suspicion of pulmonary embolism, confirmed by objective testing
Key inclusion criteria (4 listed)
- Acute symptomatic Pulmonary Embolism (PE) confirmed by:
Key exclusion criteria (7 listed)
- Contraindication for CT pulmonary angiography (allergy to iodine contrasts or creatinin clearance < 30 ml/min).
- Informed consent not obtained.
- Pregnancy.
- Life expectancy of less than 3 months.
- Hemodynamic unstability defined as SBP < 90 mm Hg, need for cardiopulmonary reanimation, need for vasoactive drugs or orotracheal intubation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The primary outcome considered will be death by any cause in the month following diagnosis.
Time frame: 30 days after PE diagnosis
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 15 Jun 2011.
- Derived from this study: PubMed 24627529Lankeit M, Jimenez D, Kostrubiec M, Dellas C, Kuhnert K, Hasenfuss G, Pruszczyk P, Konstantinides S. Validation of N-terminal pro-brain natriuretic peptide cut-off values for risk stratification of pulmonary embolism. Eur Respir J. 2014 Jun;43(6):1669-77. doi: 10.1183/09031936.00211613. Epub 2014 Mar 13.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Carlos III Health Institute at 1 site in Spain.
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 4 inclusion and 7 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 15 Jun 2011. 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 Spain. 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?
The primary outcome considered will be death by any cause in the month following diagnosis. (time frame: 30 days after PE diagnosis). 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 NCT00880737, 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 15 Jun 2011.