Acute Pulmonary EmbolismIPERNCT01604538
Italian Pulmonary Embolism Registry - IPER
An observational study of Acute Pulmonary Embolism, run by University Of Perugia.
Trial summary
RAZIONALE Pulmonary embolism is a complex disease, with a highly variable clincal presentation. Diagnosis starts with clinical probability assessment mainly based on medical history and rapidly available clinical data. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pulmonary Embolism
- How many people
- 1,700 participants
- Where
- No sites listed yet
- Study dates
- Mar 2006to not given
- 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: consecutive patients with acute pulmonary embolism
Who may be able to join
- consecutive patients with acute pulmonary embolism
Who cannot join
- age <18 years
About this study
Official title: Italian Pulmonary Embolism Registry
RAZIONALE
Pulmonary embolism is a complex disease, with a highly variable clincal presentation. Diagnosis starts with clinical probability assessment mainly based on medical history and rapidly available clinical data. Pulmonary embolism can be managed by emergency department, cardiology, pneumology geriatrics or internal medicine physicians. Thus, initial clinical management can varies based on the attitude of the attending physician.
Read more
Diagnosis is a crucial point as it can influence short term mortality.
OBJECTIVE
The registry has 3 main objectives:
- educational objective,
- improvement in the knowledge of epidemiology, management and outcome of acute pulmonary embolism in Italy
- scientific objective
- Conditions
- Acute 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 |
|---|---|---|
| patients with acute pulmonary embolism | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2012 (estimated)
- Study startMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Acute 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
- 1,700 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Of Perugia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cecilia Becattini, University Of Perugia
- Investigators
- Franco Casazza, MD, Study chair, San Carlo Borromeo hospital, Milan, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01604538
- Sponsor's protocol ID
- protocol_364
- Acronym
- IPER
- Status last verified
- May 2012
- First submitted
- 21 May 2012
- Last updated
- 23 May 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Zuin M, Bilato C, Enea I, Bongarzoni A, Casazza F, Roncon L, Becattini C. An exploratory model for short-term risk stratification in intermediate-high-risk pulmonary embolism running head: The STAMP score. Eur J Intern Med. 2026 Feb;144:106484. doi: 10.1016/j.ejim.2025.106484. Epub 2025 Aug 20.
PubMed 40841246Zuin M, Piazza G, Rigatelli G, Bongarzoni A, Enea I, Casazza F, Picariello C, Bilato C, Roncon L. Clinical phenotypes and risk of early hemodynamic deterioration in intermediate-high-risk patients with acute pulmonary embolism. Thromb Res. 2025 Aug;252:109380. doi: 10.1016/j.thromres.2025.109380. Epub 2025 Jun 10.
PubMed 40505225Zuin M, Rigatelli G, Bilato C, Bongarzoni A, Zonzin P, Casazza F, Roncon L. Risk of early clinical deterioration and 30-day mortality in pulmonary embolism intermediate-high-risk patients with patent foramen ovale. Intern Emerg Med. 2024 Sep;19(6):1637-1644. doi: 10.1007/s11739-024-03657-w. Epub 2024 May 31.
PubMed 38822190Zuin M, Piazza G, Rigatelli G, Bilato C, Bongarzoni A, Henkin S, Zonzin P, Casazza F, Roncon L. Prognostic Role of Tricuspid Annular Plane Systolic Excursion to Systolic Pulmonary Artery Pressure Ratio for the Identification of Early Clinical Deterioration in Intermediate-High-Risk Pulmonary Embolism Patients. Am J Cardiol. 2024 Mar 1;214:40-46. doi: 10.1016/j.amjcard.2023.12.053. Epub 2024 Jan 11.
PubMed 38218392Zuin M, Bilato C, Bongarzoni A, Zonzin P, Casazza F, Roncon L. Prognostic impact of the e-TAPSE ratio in intermediate-high risk pulmonary embolism patients. Int J Cardiovasc Imaging. 2024 Mar;40(3):467-476. doi: 10.1007/s10554-023-03010-w. Epub 2023 Nov 30.
PubMed 38032504Zuin M, Rigatelli G, Bongarzoni A, Enea I, Bilato C, Zonzin P, Casazza F, Roncon L. Mean arterial pressure predicts 48 h clinical deterioration in intermediate-high risk patients with acute pulmonary embolism. Eur Heart J Acute Cardiovasc Care. 2023 Feb 9;12(2):80-86. doi: 10.1093/ehjacc/zuac169.
PubMed 36580441Zuin M, Bilato C, Bongarzoni A, Zonzin P, Casazza F, Rigatelli G, Roncon L. Impact of clinical profile at admission on the outcomes in patients hospitalized for acute pulmonary embolism: data from the IPER Registry. J Thromb Thrombolysis. 2023 Jan;55(1):166-174. doi: 10.1007/s11239-022-02726-1. Epub 2022 Nov 9.
PubMed 36350468Becattini C, Casazza F, Forgione C, Porro F, Fadin BM, Stucchi A, Lignani A, Conte L, Imperadore F, Bongarzoni A, Agnelli G. Acute pulmonary embolism: external validation of an integrated risk stratification model. Chest. 2013 Nov;144(5):1539-1545. doi: 10.1378/chest.12-2938.
PubMed 23764909
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Italian Pulmonary Embolism Registry
- ClinicalTrials.gov ID
- NCT01604538
- Acronym / sponsor ID
- IPER / protocol_364
- Conditions
- Acute Pulmonary Embolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,700 participants (actual)
- Lead sponsor
- University Of PerugiaUniversity, hospital or other
- Study start
- Mar 2006
- First posted
- 23 May 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.
RAZIONALE
Pulmonary embolism is a complex disease, with a highly variable clincal presentation. Diagnosis starts with clinical probability assessment mainly based on medical history and rapidly available clinical data. Pulmonary embolism can be managed by emergency department, cardiology, pneumology geriatrics or internal medicine physicians. Thus, initial clinical management can varies based on the attitude of the attending physician.
Diagnosis is a crucial point as it can influence short term mortality.
OBJECTIVE
The registry has 3 main objectives:
- educational objective,
- improvement in the knowledge of epidemiology, management and outcome of acute pulmonary embolism in Italy
- scientific objective
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with acute pulmonary embolism | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- consecutive patients with acute pulmonary embolism
Key inclusion criteria (1 listed)
- consecutive patients with acute pulmonary embolism
Key exclusion criteria (1 listed)
- age <18 years
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
Not reported in the source record.
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 23 May 2012.
- Derived from this study: PubMed 40841246Zuin M, Bilato C, Enea I, Bongarzoni A, Casazza F, Roncon L, Becattini C. An exploratory model for short-term risk stratification in intermediate-high-risk pulmonary embolism running head: The STAMP score. Eur J Intern Med. 2026 Feb;144:106484. doi: 10.1016/j.ejim.2025.106484. Epub 2025 Aug 20.
- Derived from this study: PubMed 40505225Zuin M, Piazza G, Rigatelli G, Bongarzoni A, Enea I, Casazza F, Picariello C, Bilato C, Roncon L. Clinical phenotypes and risk of early hemodynamic deterioration in intermediate-high-risk patients with acute pulmonary embolism. Thromb Res. 2025 Aug;252:109380. doi: 10.1016/j.thromres.2025.109380. Epub 2025 Jun 10.
- Derived from this study: PubMed 38822190Zuin M, Rigatelli G, Bilato C, Bongarzoni A, Zonzin P, Casazza F, Roncon L. Risk of early clinical deterioration and 30-day mortality in pulmonary embolism intermediate-high-risk patients with patent foramen ovale. Intern Emerg Med. 2024 Sep;19(6):1637-1644. doi: 10.1007/s11739-024-03657-w. Epub 2024 May 31.
- Derived from this study: PubMed 38218392Zuin M, Piazza G, Rigatelli G, Bilato C, Bongarzoni A, Henkin S, Zonzin P, Casazza F, Roncon L. Prognostic Role of Tricuspid Annular Plane Systolic Excursion to Systolic Pulmonary Artery Pressure Ratio for the Identification of Early Clinical Deterioration in Intermediate-High-Risk Pulmonary Embolism Patients. Am J Cardiol. 2024 Mar 1;214:40-46. doi: 10.1016/j.amjcard.2023.12.053. Epub 2024 Jan 11.
- Derived from this study: PubMed 38032504Zuin M, Bilato C, Bongarzoni A, Zonzin P, Casazza F, Roncon L. Prognostic impact of the e-TAPSE ratio in intermediate-high risk pulmonary embolism patients. Int J Cardiovasc Imaging. 2024 Mar;40(3):467-476. doi: 10.1007/s10554-023-03010-w. Epub 2023 Nov 30.
- Derived from this study: PubMed 36580441Zuin M, Rigatelli G, Bongarzoni A, Enea I, Bilato C, Zonzin P, Casazza F, Roncon L. Mean arterial pressure predicts 48 h clinical deterioration in intermediate-high risk patients with acute pulmonary embolism. Eur Heart J Acute Cardiovasc Care. 2023 Feb 9;12(2):80-86. doi: 10.1093/ehjacc/zuac169.
- Derived from this study: PubMed 36350468Zuin M, Bilato C, Bongarzoni A, Zonzin P, Casazza F, Rigatelli G, Roncon L. Impact of clinical profile at admission on the outcomes in patients hospitalized for acute pulmonary embolism: data from the IPER Registry. J Thromb Thrombolysis. 2023 Jan;55(1):166-174. doi: 10.1007/s11239-022-02726-1. Epub 2022 Nov 9.
- Derived from this study: PubMed 23764909Becattini C, Casazza F, Forgione C, Porro F, Fadin BM, Stucchi A, Lignani A, Conte L, Imperadore F, Bongarzoni A, Agnelli G. Acute pulmonary embolism: external validation of an integrated risk stratification model. Chest. 2013 Nov;144(5):1539-1545. doi: 10.1378/chest.12-2938.
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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.
Franco Casazza, MD study chair
San Carlo Borromeo hospital, Milan, Italy
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Pulmonary Embolism, run by University Of Perugia.
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 1 inclusion and 1 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 23 May 2012. Status can change between updates, so confirm with the study contact before making plans.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01604538, which also lists 8 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 23 May 2012.